Calcium-Silicate Cements: MTA, Biodentine and Bioceramic Putties Compared
Sixteen repair and pulp-capping cements from ten manufacturers, with the setting times, radiopacity, pH, labelled indications, contraindications, handling warnings and restoration timing that their own instructions for use, safety data sheets and brochures print.
Last updated: September 2026
Overview
Sixteen repair and pulp-capping cements from ten manufacturers, with the setting times, radiopacity, pH, labelled indications, contraindications, handling warnings and restoration timing that their own instructions for use, safety data sheets and brochures print. Dycal, a calcium hydroxide liner, sits at the end as the comparator most clinical studies measure against. Values are copied from the documents; a cell reading "not stated" means the obtained documents carry no such figure, not that the property is unknown.
Tier tags tell you where a value comes from: IFU values are labelling; SDS values come from the safety data sheet and often describe the powder, not the set cement; brochure values are the manufacturer's marketing and are shown with that tag. Setting times are only comparable when the test is named; most IFUs print a single undifferentiated "setting time".
Specification table
01ProRoot MTADentsply Sirona
Manufacturer
Dentsply Sirona
Solubility (%)
not stated in the obtained documents
02MTA AngelusAngelus
Manufacturer
Angelus
Solubility (%)
IFU: "Low solubility" only. Profile: 0.84 ± 0.33 % *(brochure)*. Line folder: 0.1% in an unlabelled table *(brochure)*, see flagsBrochure
03MTA Repair HPAngelus
Manufacturer
Angelus
Solubility (%)
IFU: "Low solubility" only. Folder: −0.02 % *(brochure)*Brochure
04MTA FlowUltradent
Manufacturer
Ultradent
Solubility (%)
Powder "Solubility in Water: < 3 %" *(SDS)* — ledger note: a powder SDS figure, not an ISO 6876 set-material valueSDS
05NeoMTA 2NuSmile
Manufacturer
NuSmile
Solubility (%)
< 3 %, "as required" — listed under the IFU heading "ADA 57, ISO 6876 and ISO 9917-1 criteria" (the heading also covers the other physical properties on that page)
06BiodentineSeptodont
Manufacturer
Septodont
Solubility (%)
not stated in the obtained documents
07Biodentine XPSeptodont
Manufacturer
Septodont
Solubility (%)
not stated in the obtained documents
08Bio-C RepairAngelus
Manufacturer
Angelus
Solubility (%)
< 3 %; ISO 6876:2012 test table "Average" 0.39 % *(brochure)*Brochure
09NeoPUTTYNuSmile
Manufacturer
NuSmile
Solubility (%)
< 3 %
10EndoSequence BC RRMBrasseler USA
Manufacturer
Brasseler USA
Solubility (%)
not stated in the obtained documents
11TotalFill BC RRMFKG Dentaire
Manufacturer
FKG Dentaire
Solubility (%)
not stated in the obtained documents
12iRoot BP PlusInnovative BioCeramix
Manufacturer
Innovative BioCeramix
Solubility (%)
not stated in the obtained documents
13CeraPuttyMeta Biomed
Manufacturer
Meta Biomed
Solubility (%)
not stated in the obtained documents
14TheraCal LCBISCO
Manufacturer
BISCO
Solubility (%)
not stated in the obtained documents
15TheraCal PTBISCO
Manufacturer
BISCO
Solubility (%)
not stated in the obtained documents
16Dycal ComparatorDentsply Sirona
Manufacturer
Dentsply Sirona
Solubility (%)
not stated in the obtained documents
Product by product
ProRoot MTA
The original mineral trioxide aggregate: a tri- and dicalcium silicate powder with bismuth oxide as radiopacifier, mixed with the supplied water ampoule. Sold as 0.5 g pouches (white in the EU labelling; the brochure also lists grey and 1 g). Radiopacity is labelled as at least 4 mm Al and compressive strength above 24 MPa.
Indications as labelled
- Root-end filling
- Apical plug during apexification
- Repair of root perforations
- Internal resorption
- Pulp capping
- Pulpotomy of primary teeth (ages > 2–12 and > 12–21)
Contraindications
- None known, according to the IFU
Warnings and precautions
- Store dry; the powder is moisture-sensitive
- Place immediately after mixing to avoid dehydration
- In the aesthetic zone, weigh the procedure and the exposed surface
- Avoid skin contact (irritation in the US labelling, corrosion in the EU labelling); wear protective clothing
- Single use
Restoration timing
Canal procedures: temporary restoration for at least 4 hours, check hardness after 4 hours or at the next appointment, then obturate. Pulp capping: cover with a flowable compomer or liner and restore. Primary pulpotomy: fill the chamber and fit a stainless-steel crown.
Discolouration
The EU IFU lists slight tooth discolouration in the following months as a possible adverse reaction; an aesthetic-zone precaution is printed in both IFUs.
All labelled values
- Class
- Tri-/di-calcium silicate cement (mineral trioxide aggregate) with bismuth oxide
- Composition as listed
- Tri- and di-calcium silicates 69–74 %; minor components 2–7 % combined; bismuth oxide 17–22 % (IFU). SDS: Portland cement + bismuth oxide (+ gypsum in AU SDS)
- Presentation
- Powder–liquid: 0.5 g powder pouches + water ampoules (EUR: white shade); brochure lists white and gray, ½-gram and 1-gram
- Mixing / working time
- Mix about 1 min with the supplied liquid; working time ≈ 3 min. NAM pulpotomy protocol instead mixes the powder with sterile saline at 3:1 to a putty consistency
- Final setting
- Net setting time ≈ 6 h (EUR properties list); "will set over a period of three hours" (both IFUs' mixing notes); full cure over four weeks
- Radiopacity (mm Al)
- ≥ 4 mm Al
- Compressive strength (MPa)
- > 24 MPa
- pH
- Basic (IFU); 12 to 13 *(US SDS)*; 12–13 as a 1 % solution *(AU SDS)*SDS
- Indications as labelled
- Root-end filling · apical plug in apexification · root perforation repair · internal resorption · pulp capping · pulpotomy of primary teeth in the child (ages > 2–12 years) and adolescent (ages > 12–21 years) populations
- Primary-teeth labelling
- Yes — pulpotomy of primary teeth
- Contraindications
- None known
- Warnings and precautions
- Moisture-sensitive storage; place immediately after mixing; aesthetic-zone precaution; skin contact (NAM: irritation/allergy; EUR: corrosion); PPE; single use; slight tooth discolouration listed as adverse reaction (EUR)
- Restoration timing
- Canal procedures: temporary restoration ≥ 4 h, check hardness after 4 h or next appointment, then obturate. Pulp capping: cover with flowable compomer/liner and restore in the same sequence. Pulpotomy: fill chamber and fit SSC
- IFU document and revision
- NAM: END-IFU-PROROOT-MTA-V06-WEB-NAM-EN-2025-01. EUR: REF. A0405, Basic UDI-DI ++D716MTA012K; version/date carried only in the file stem (V05, 2025-08)
MTA Angelus
A powder-and-distilled-water MTA in grey and white, mixed for 30 seconds (one sachet or spoon to one drop) with a labelled setting time of 15 minutes. The IFU gives only qualitative physical properties; the technical profile adds radiopacity of about 7 mm Al, a pH rising from 10.2 after mixing to 12.5 after setting, and solubility of 0.84 ± 0.33 %.
Indications as labelled
- Perforation of root canal or furcation, iatrogenic or carious
- Perforation from internal resorption, via the canal or surgically
- Periapical surgery with root-end filling
- Direct pulp capping
- Pulpotomy
- Apexogenesis
- Apexification
Contraindications
- Allergy to the components
Warnings and precautions
- Avoid contact with eyes, skin and oral mucosa
- Open only immediately before use; very moisture-sensitive
- Use only after the acute phase is controlled: an acidic pH compromises setting
- Excess material can make healing difficult; not a root-canal filling; keep away from the gingival groove
- Grey MTA in light-exposed areas may stain the tooth; the white version is labelled as non-staining
- Safety in pregnancy and in children not established
Restoration timing
Not stated in the IFU; the technical profile, in the pulp-capping context, restores immediately.
Discolouration
The IFU warns that grey MTA may stain in light-exposed areas and states that the bismuth-free white version does not stain dentine.
All labelled values
- Class
- Endodontic repair cement based on mineral trioxide aggregate (MTA), described as hydraulic and bioceramic *(brochure)*Brochure
- Composition as listed
- Gray: tricalcium silicate, dicalcium silicate, tricalcium aluminate, calcium oxide, iron tetracalcium aluminate, bismuth oxide. White: tricalcium silicate, dicalcium silicate, tricalcium aluminate, calcium oxide, calcium tungstate
- Presentation
- Powder (sachet or bottle) mixed with distilled water; TSP pack sizes 1 g / 2 g Grey and 1 g / 5 g White; the line folder also lists a 2 g White pack (8214) and a 3 g pack (8247) *(brochure)*Brochure
- Mixing / working time
- Mix 30 s, 1 sachet or spoon to 1 drop distilled water; no numeric working time (it can be extended under wet gauze)
- Final setting
- Unqualified "setting time": 15 min
- Radiopacity (mm Al)
- IFU: qualitative only. Profile: ≥ 7 / 7.171 / ≥ 7.2 mm Al *(brochure)*Brochure
- pH
- IFU: "High alkalinity" only. Profile: 10.2 after mixing, 12.5 after setting / after 3 h *(brochure)*Brochure
- Solubility (%)
- IFU: "Low solubility" only. Profile: 0.84 ± 0.33 % *(brochure)*. Line folder: 0.1% in an unlabelled table *(brochure)*, see flagsBrochure
- Indications as labelled
- 1 perforation of root canal / furcation (iatrogenic or carious) · 2 perforation from internal resorption, via canal · 3 the same, surgical · 4 periapical surgery with reverse (root-end) filling · 5 direct pulp capping · 6 pulpotomy · 7 apexogenesis · 8 apexification
- Primary-teeth labelling
- IFU: no primary-tooth indication; safety in children not established. Profile: pulpotomy and pulp capping "in deciduous and permanent teeth" *(brochure)*Brochure
- Contraindications
- Allergy to components
- Warnings and precautions
- Eye, skin and mucosa contact; moisture-sensitive; use only after the acute phase is controlled (acidic pH compromises setting); excess can hinder healing; not a root-canal filling; not in contact with the "gingival groove" (sulcus); Gray may stain in light-exposed areas; White "does not stain"; safety not established in pregnancy or children
- Restoration timing
- IFU: not stated. Profile (pulp capping context): restore immediately *(brochure)*Brochure
MTA Repair HP
A high-plasticity MTA supplied as single-use capsule pairs (0.085 g powder, 0.25 mL liquid), spatulated for 40 seconds and setting in 15 minutes. It uses calcium tungstate instead of bismuth oxide as radiopacifier; the folder gives 6.1 mm Al, a pH of 10.2 rising to 13.1 after 3 hours, and a negative solubility figure.
Indications as labelled
- Perforation of root canal or furcation, iatrogenic or carious
- Perforation from internal resorption, via the canal or surgically
- Periapical surgery with root-end filling
- Direct pulp capping
- Pulpotomy
- Apexogenesis
- Apexification
Contraindications
- Allergy to the components
Warnings and precautions
- Avoid contact with eyes, skin and oral mucosa
- Open only immediately before use; very moisture-sensitive
- Use only after acute signs and symptoms remit: an acidic pH prevents the setting reaction
- Do not let it overflow beyond the cavity; not a root-canal filling; it disintegrates in contact with the gingival sulcus
- Safety in pregnancy and in children not established
Restoration timing
Not stated in the obtained documents.
Discolouration
The IFU states the absence of dental pigmentation, attributing it to the calcium tungstate radiopacifier; the folder calls the product bismuth-free and non-staining.
All labelled values
- Class
- High-plasticity bioceramic reparative cement of mineral oxides
- Composition as listed
- Powder: tricalcium silicate, dicalcium silicate, tricalcium aluminate, calcium oxide, calcium tungstate. Liquid: water and plasticizer
- Presentation
- Powder–liquid in single-use capsules (0.085 g powder / 0.25 ml liquid); packs of 2, 5 and 10 capsule pairs *(brochure)*Brochure
- Mixing / working time
- 1 package powder + 2 drops liquid, spatulate 40 s; no working time stated
- Final setting
- 15 min (IFU unqualified; the folder calls it the "final setting time")
- Radiopacity (mm Al)
- IFU: qualitative only. Folder: 6.1 mm Al *(brochure)*Brochure
- pH
- IFU: "High alkalinity" only. Folder: initial 10.2, 13.1 after 3 h *(brochure)*Brochure
- Solubility (%)
- IFU: "Low solubility" only. Folder: −0.02 % *(brochure)*Brochure
- Indications as labelled
- 1 perforation of root canal / furcation (iatrogenic or carious) · 2 perforation from internal resorption, via canal · 3 the same, surgical · 4 periapical surgery with reverse filling · 5 pulp capping (the summary sentence on {4} says "direct pulp capping") · 6 pulpotomy · 7 apexogenesis · 8 apexification
- Contraindications
- Allergy to components
- Warnings and precautions
- Eye, skin and mucosa contact; moisture-sensitive; not a root-canal filling; disintegrates in contact with the gingival sulcus; use only after acute signs remit (acidic pH prevents setting); overflow can slow healing; single-use capsules; safety not established in pregnancy or children; no dental pigmentation (CaWO4 radiopacifier)
- IFU document and revision
- Document code 1050843; issue date 10/02/2024 (date format not specified in the document)
MTA Flow
Ultradent's powder-and-gel MTA in grey and white, dosed by measuring spoon and gel drops to three consistencies: thick for pulp capping, chamber perforations and pulpotomy; thin for resorption, apexification and apical plugs; putty for root-end filling. The gel is water-based and acidic (pH 3–4) while the mixed cement is about pH 12. Once loaded into the Skini syringe the mix stays usable for up to 15 minutes; no setting time is printed in the English IFU.
Indications as labelled
- Vital pulp: primary-dentition vital pulpotomy; pulp capping
- Periradicular: root-end filling; apexification; perforation repair; root resorption
- The directions also describe an apical-plug technique
Contraindications
- Hypersensitivity to caustic, high-pH solutions
- Not for root canal disinfection
- Primary-tooth pulpectomy, unless the permanent successor is absent
Warnings and precautions
- Limited antimicrobial action; setting is inhibited in acidic or infected sites
- Not for cervical resorption
- Keep unset paste off skin and mucosa; keep the powder sealed against humidity
- Do not overfill; not a sole canal filling (hard to retreat); keep away from the gingival sulcus
- Sterile water only during primary pulpotomy
Restoration timing
No interval is stated. The pulp-capping and pulpotomy steps place a flowable composite or resin-modified glass ionomer over the cement right after air-drying.
Discolouration
No discolouration statement was found in the English text of the obtained documents.
All labelled values
- Class
- Tricalcium/dicalcium silicate powder set with a water-based gel (powder–gel MTA)
- Composition as listed
- IFU: tricalcium and dicalcium silicate powder + water-based gel. SDS grey powder: tricalcium silicate < 50 %, tantalite (Ta2O5) < 50 %, dicalcium silicate < 20 %, calcium sulfate < 5 %, tricalcium aluminate < 5 % *(SDS)*. SDS white powder: tricalcium silicate, tantalite, dicalcium silicate, calcium sulfate — names only, no percentages and no tricalcium aluminate line *(SDS)*. Gel: no hazardous components listed *(SDS)*SDS
- Presentation
- Powder (grey or white) + gel in bottles; measuring spoon; optional Skini syringe delivery
- Mixing / working time
- Proportions depend on use: pulp capping, pulp-chamber perforation and pulpotomy "2 big ends (0.26g)" + 3 drops (thick); resorption, apexification and apical plug 0.19 g + 3 drops (thin); root-end filling 0.19 g + 1 drop (putty). Once loaded in the Skini syringe the mix is usable for up to 15 min. No other working time stated
- pH
- Powder mixed with water ~12; gel pH 3–4 *(SDS)*. The IFU's "caustic (high pH)" wording is a hypersensitivity contraindication, not a measured pHSDS
- Solubility (%)
- Powder "Solubility in Water: < 3 %" *(SDS)* — ledger note: a powder SDS figure, not an ISO 6876 set-material valueSDS
- Indications as labelled
- Vital pulp: 1 primary dentition vital pulpotomy · 2 pulp capping. Periradicular: 1 root-end filling · 2 apexification · 3 perforation repair · 4 root resorption. (Directions for use also give an "Apical Plug" technique.)
- Primary-teeth labelling
- Labelled for primary dentition vital pulpotomy; primary-tooth pulpectomy contraindicated unless the successor is absent; sterile water only during primary pulpotomy
- Contraindications
- Hypersensitivity to caustic (high-pH) solutions, and not for root canal disinfection; primary-tooth pulpectomy unless the successor is absent
- Warnings and precautions
- Limited antimicrobial action; alkaline powder; setting inhibited in acidic/infected sites; not for cervical resorption; unset paste on skin or mucosa; keep sealed (humidity-sensitive); do not overfill; not as a sole canal filling (hard to retreat); not in contact with the gingival sulcus; not in patients sensitive to tricalcium silicates. No discolouration statement found in the English text
- IFU document and revision
- 1008116AR01, dated 012020 (© 2020)
NeoMTA 2
NuSmile's powder-and-gel MTA, formulated with tantalum oxide instead of bismuth oxide and labelled as non-discolouring in primary and permanent teeth. One scoop of powder with one or two drops of gel gives about 14 minutes of working time as a putty (21 minutes thinner). Initial set is 14 minutes and final set 1 h 45 min at 37 °C; radiopacity is 6.5 mm Al as a putty and 5.4 mm Al when mixed for sealer use.
Indications as labelled
- Indirect and direct pulp capping
- Partial pulpotomy and pulpotomy
- Cavity liner and base
- Apexogenesis
- Resorption
- Obturation
- Apexification
Contraindications
- Hypersensitivity to caustic, high-pH solutions
- Primary-tooth pulpectomy, unless the permanent successor is absent
Warnings and precautions
- Caustic powder; keep unset paste off skin and mucosa
- Protect the powder from humidity
- Do not overfill; setting is inhibited in acidic or infected sites
- Bleeding that lasts more than 10 minutes suggests irreversible pulpitis
Restoration timing
Vital pulp procedures: restore immediately, the mix is washout-resistant. Resorption: obturate once the material is firm, after a few minutes. Apexification: a full-coverage restoration normally follows.
Discolouration
The IFU states the product was developed to prevent discolouration in primary or permanent teeth and that it does not discolour teeth.
All labelled values
- Class
- Powder–gel tricalcium/dicalcium silicate (MTA-type), "bioactive bioceramic"
- Composition as listed
- Powder: tricalcium silicate < 50 %, tantalite (Ta2O5) < 50 %, dicalcium silicate < 20 %, calcium sulfate < 5 %, tricalcium aluminate (percentage cell unclear in extraction) *(SDS)*. Gel: water-based (> 50 % water), proprietary *(FAQ)*, no hazardous components *(SDS)*Mixed sources
- Presentation
- Powder in a desiccant-lined container + gel bottle; professional kit 2.5 g powder / 4.0 cc gel *(brochure)*Brochure
- Mixing / working time
- 1 scoop (≈0.05 or 0.1 g) + 1–2 drops gel, adjusted to consistency; working time ~14 min as putty (IFU); FAQ: ~14 min putty, 21 min thinner
- Initial setting
- 14 min (putty consistency, 37 °C)
- Final setting
- Final 1:45 h, initial 14 min (putty consistency, 37 °C, IFU). FAQ: a thick mix "takes about 14 minutes to set within the tooth"; a thinner sealer-type mix sets in ~1 h 10 min *(FAQ)*FAQ
- Radiopacity (mm Al)
- 6.5 mm Al (putty consistency); 5.4 mm Al when "mixed for sealer use" (IFU; the marker extraction truncates this sentence, the pdftotext file completes it)
- pH
- Powder mixed with water ~12 *(SDS)*; gel 3–4 *(SDS)*; "initially high pH" *(FAQ)*Mixed sources
- Solubility (%)
- < 3 %, "as required" — listed under the IFU heading "ADA 57, ISO 6876 and ISO 9917-1 criteria" (the heading also covers the other physical properties on that page)
- Indications as labelled
- Indirect pulp cap · direct pulp cap · partial pulpotomy · cavity liner · base · pulpotomy · apexogenesis · resorption · obturation · apexification (10)
- Primary-teeth labelling
- IFU: developed to prevent discolouration "in primary or permanent teeth"; primary-tooth pulpectomy contraindicated unless the successor is absent. Marketing: for paediatric dentists *(brochure)*Brochure
- Contraindications
- Hypersensitivity to caustic (high-pH) solutions; primary-tooth pulpectomy unless the successor is absent
- Warnings and precautions
- Caustic powder; unset paste on skin or mucosa; protect the powder from humidity; do not overfill; setting inhibited in acidic/infected sites; bleeding > 10 min suggests irreversible pulpitis. "Does not discolor teeth"
- Restoration timing
- Vital pulp procedures: restore immediately (washout resistant). Resorption: obturate once the material is firm ("a few minutes"). Apexification: full-coverage restoration normally follows
Biodentine
A tricalcium silicate powder in a capsule, activated with five drops of an aqueous calcium chloride liquid and mixed for 30 seconds on a mixing device at 4000–4200 rpm. Labelled as a dentine substitute as much as a pulp material: the crown indications include restorations under composite. Initial set is 12 minutes from the start of mixing; the brochure gives a pH of about 12.
Indications as labelled
- Crown: permanent dentine restoration under composite, inlay or onlay; temporary dentine-enamel restoration; deep or large coronal caries (sandwich); cervical and radicular lesions
- Pulp capping and pulpotomy
- Root: root and furcation perforations; perforating internal resorption; external resorption; apexification; root-end filling
Contraindications
- Allergy to an ingredient
- The IFU lists limits of use separately (e.g. not for irreversible pulpitis)
Warnings and precautions
- Use a rubber dam
- Keep water and fluids away during the 12-minute initial set
- Achieve haemostasis before placement
- Single use
Restoration timing
Enamel restoration immediately after the 12-minute set, or the definitive restoration within one week to six months. Perforation, resorption and apexification: temporary filling, then complete the root canal treatment at the next visit.
Discolouration
The IFU makes no discolouration statement; the brochure claims none.
All labelled values
- Class
- Tricalcium silicate powder + aqueous calcium chloride liquid
- Composition as listed
- IFU: tricalcium silicate powder; aqueous calcium chloride solution and excipients. SDS lists calcium carbonate, zirconium oxide (powder) and calcium chloride dihydrate (liquid)
- Presentation
- Capsules + single-dose liquid containers; box of 15 (IFU); brochure adds box of 5
- Mixing / working time
- 5 drops liquid into capsule; mix 30 s on a mixing device at 4000–4200 rpm; working time not given numerically
- Initial setting
- 12 min from start of mix
- pH
- High pH (= 12) *(brochure)*; liquid pH 3.5–5 *(SDS, liquid as supplied)*Mixed sources
- Indications as labelled
- Crown: permanent dentin restoration under composite/inlay/onlay · temporary dentin-enamel restoration · deep/large coronal carious lesions (sandwich) · cervical radicular lesions · pulp capping · pulpotomy. Root: root perforations · furcation perforations · perforating internal resorptions · external resorption · apexification · root-end filling
- Contraindications
- Allergy to an ingredient; limits of use listed separately
- Warnings and precautions
- Rubber dam; avoid water/fluids during initial set (12 min); single use; not for irreversible pulpitis; haemostasis before placement; no known side effects. Discolouration: brochure claims none
- Restoration timing
- Immediate enamel restoration after the 12-min set; or definitive restoration within 1 week–6 months; root perforation / resorption / apexification: temporary filling, complete RCT at next visit; furcation: permanent restoration at a subsequent visit
- IFU document and revision
- US IFU (EN/FR/ES), no document title/revision line beyond the manufacturer code string
Biodentine XP
The cartridge version of Biodentine: powder and liquid pre-dosed in one cartridge (XP 500 = 700 mg / 190 µL, XP 200 = 468 mg / 133 µL), mixed for 30 seconds in the Biodentine Mixer and dispensed with the Biodentine Gun. Setting time averages 12 minutes from the end of mixing (range 9–25). The EU IFU labels compressive strength at 150 MPa or more at 24 hours and 260–300 MPa after 28 days.
Indications as labelled
- Crown (primary and permanent teeth): permanent dentine restoration under composite, inlay or onlay; temporary dentine-enamel restoration; deep or large coronal caries (sandwich); cervical or radicular lesions
- Pulp (primary and permanent): direct and indirect pulp capping; pulpotomy for reversible and irreversible pulpitis when bleeding is controlled within 5 minutes
- Root (permanent): root and furcation perforations; perforating internal resorption; external resorption; root-end filling
- Immature permanent teeth: apexification; revitalisation (EU labelling only)
Contraindications
- Hypersensitivity to the material
- Large loss of tooth substance under high occlusal stress
- Pulp space that will need a post and core (EU labelling)
Warnings and precautions
- May irritate the eyes; wear protective equipment
- Water contamination slows the set; use a rubber dam
- Mix and dispense only with the Biodentine Mixer and Gun; discard a mix that is not homogeneous and creamy
- For revitalisation, wait for the blood clot; vasoconstrictor anaesthetics may prevent it
- Flush the canal with sterile saline to remove irrigant residues
- Single use; hypersensitivity estimated at under 1 in 100 000
Restoration timing
Wait until the end of the setting time before the permanent enamel restoration or removing the matrix. The procedures guide places the second session one week to six months later; the brochures allow the same session or two weeks to six months.
Discolouration
No discolouration statement in the obtained documents.
All labelled values
- Class
- Tricalcium silicate powder + calcium chloride/polycarboxylate liquid, pre-dosed cartridge
- Composition as listed
- Powder: tricalcium silicate, zirconium oxide, calcium oxide, calcium carbonate, iron oxides. Liquid: calcium chloride, polycarboxylate, purified water
- Presentation
- All-in-one cartridge (powder + liquid), XP 500 = 700 mg / 190 µL, XP 200 = 468 mg / 133 µL; boxes of 10; mixed in Biodentine Mixer, dispensed with Biodentine Gun
- Mixing / working time
- Mixing 30 s in Biodentine Mixer; working time ≥ 1 min; discard if 3 min elapse between activation and mixing
- Final setting
- Average 12 min from end of mixing (range 9–25 min) — single "setting time"
- Compressive strength (MPa)
- ≥ 150 MPa at 24 h; 260–300 MPa after 28 days (EU IFU); the brochure's "300 MPa after one month" sentence is written about Biodentine™, not Biodentine XP *(brochure)*Brochure
- pH
- pH 10.99 at release, > 11 for 28 days *(brochure)*; SDS: not applicable / not determinedBrochure
- Indications as labelled
- Crown (temporary + permanent teeth): permanent dentine restoration under composite/inlay/onlay · temporary dentine-enamel restoration · deep/large coronal carious lesions (sandwich) · cervical or radicular lesions. Pulp (temporary + permanent): pulp capping (direct and indirect) · pulpotomy for reversible and irreversible pulpitis with bleeding controlled within 5 min. Root (permanent): root perforations · furcation perforations · perforating internal resorptions · external resorption · root-end filling. Immature permanent: apexification · revitalisation (EU only)
- Primary-teeth labelling
- Yes — crown and pulp indications for temporary teeth from 2 years; root indications permanent teeth only; limited clinical data 2–6 years
- Contraindications
- Hypersensitivity; large tooth-substance loss under high stress; pulp space needing post/core (EU)
- Warnings and precautions
- Eye irritation / PPE; water contamination slows set; rubber dam; single use; Mixer/Gun only; discard if not homogeneous and creamy; wait for set before enamel restoration; revitalisation clot / vasoconstrictor; saline flush in endo; hypersensitivity < 1/100 000. No discolouration statement
- Restoration timing
- Wait until end of setting time before permanent enamel restoration or matrix removal; procedures guide: second session 1 week–6 months; brochures: same session or 2 weeks–6 months
- IFU document and revision
- EU/UK multilingual cartridge IFU (Basic UDI-DI 37601407000004G9); no revision or date string in the extracted text — "2024" is from the file stem only. US IFU: no revision string
Bio-C Repair
A ready-to-use bioceramic putty from Angelus in a screw-in syringe or single-dose capsule, with zirconium oxide as radiopacifier. The IFU labels setting at 30–120 minutes depending on moisture; the brochure adds radiopacity of 7 mm Al or more, a pH near 12, solubility averaging 0.39 % on the ISO 6876 test and compressive strength of 7.933 ± 3.284 MPa.
Indications as labelled
- Root or furcation perforation, via the canal or surgically
- Internal resorption, via the canal or surgery
- External resorption
- Root-end filling in periapical surgery
- Direct and indirect pulp capping
- Apexification and apexogenesis
- Pulpotomy
Contraindications
- Expired product or damaged packaging
- Filling root canals (flow is inadequate)
- Sensitivity to the components
Warnings and precautions
- Avoid contact with eyes, skin and oral mucosa; keep out of reach of children
- Rubber dam for all canal uses
- Moisture-sensitive: close the package firmly; discard a hardened syringe tip
- Use only after the infection is controlled: acidic pH prevents setting
- Not indicated for external resorption above the bone crest
- In primary or young permanent teeth with a large exposure, the protocol switches from capping to pulpotomy
Restoration timing
Pulp capping: cover with glass ionomer and wait 4–6 weeks before the final restoration. Perforation: no composite directly on the material before the final set. Pulpotomy: provisional glass-ionomer restoration.
Discolouration
The IFU carries no discolouration statement; the brochure says the material does not stain.
All labelled values
- Class
- Ready-to-use (premixed) bioceramic repair cement, putty
- Composition as listed
- IFU: calcium silicate, calcium aluminate, calcium oxide, zirconium oxide, iron oxide, silicon dioxide, dispersing agent. Profile table: tricalcium silicate, dicalcium silicate, tricalcium aluminate, calcium oxide, zirconium oxide (radiopacity), silicon oxide, polyethylene glycol (dispersing agent), iron oxide (pigmentation) *(brochure)*Brochure
- Presentation
- Screw-in syringe and single-dose capsule (for a dispensing gun)
- Mixing / working time
- Ready to use, no mixing; no numeric working time
- Final setting
- Unqualified "setting time": IFU 30–120 min; brochure ≤ 120 min / "around 120 minutes"; moisture-dependent
- Radiopacity (mm Al)
- IFU: qualitative only. Brochure: ≥ 7.0 mm Al (ISO 6876:2012) *(brochure)*Brochure
- Compressive strength (MPa)
- 7.933 ± 3.284 MPa *(brochure)*Brochure
- pH
- IFU: "High alkalinity" only. Brochure: ~12 *(brochure)*Brochure
- Solubility (%)
- < 3 %; ISO 6876:2012 test table "Average" 0.39 % *(brochure)*Brochure
- Indications as labelled
- A root/furcation perforation, via canal · B root/furcation perforation, surgical · C internal resorption, via canal or surgery · D external resorption · E retrograde filling in periapical surgery · F direct and indirect pulp capping · G apexification / apexogenesis · H apexogenesis and pulpotomy
- Primary-teeth labelling
- Pulp-capping protocol: for primary or young permanent teeth with a large exposure, do a pulpotomy instead. Safety not established in "vulnerable populations"
- Contraindications
- Past expiry; damaged packaging; filling canals (flow inadequate); sensitivity to components
- Warnings and precautions
- Eye, skin and mucosa contact; vulnerable populations; keep away from children; rubber dam for canal use; moisture-sensitive; discard hardened syringe tip; use only after infection is controlled (acidic pH prevents setting); not indicated for external resorption above the bone crest. IFU has no discolouration statement; brochure says "Does not stain" *(brochure)*Brochure
- Restoration timing
- Pulp capping: cover with glass ionomer and wait 4–6 weeks before the final restoration; perforation: no composite directly over the material before final set; pulpotomy: provisional glass-ionomer restoration
NeoPUTTY
NuSmile's premixed tricalcium/dicalcium silicate putty in a water-free organic carrier that sets with tissue moisture, with tantalum oxide as radiopacifier. No mixing; working time over an hour at room temperature; initial set about 4 hours at 37 °C in a moist environment. Radiopacity is 8.4 mm Al in the IFU (8.1 in the FAQ) and solubility under 3 %.
Indications as labelled
- Vital pulp: indirect and direct pulp capping; partial pulpotomy and pulpotomy; cavity liner and base; apexogenesis
- Periradicular: perforation repair; resorption; obturation; apexification; root-end filling
- Complete endodontic obturation where applicable
Contraindications
- Hypersensitivity to caustic, high-pH solutions
- Primary-tooth pulpectomy, unless the permanent successor is absent
Warnings and precautions
- Caustic; keep unset putty off skin and mucosa
- Keep sealed and recap immediately; non-sterile and cannot be sterilised
- Do not overfill; setting is inhibited in acidic or infected sites
- Bleeding that lasts more than 10 minutes suggests irreversible pulpitis
- Do not etch or bond directly to the putty (brochure)
Restoration timing
Restore immediately; the putty is washout-resistant and keeps setting under the restoration for about 4 hours. Apexification: a full-coverage restoration normally follows.
Discolouration
The IFU states that the product does not discolour teeth.
All labelled values
- Class
- Premixed (ready-to-use) tricalcium/dicalcium silicate paste in a water-free organic carrier; sets with tissue moisture
- Composition as listed
- IFU: tricalcium/dicalcium silicate powder in an organic medium. SDS: tantalite < 50 %, tricalcium silicate < 25 %, calcium aluminate < 25 %, dicalcium silicate < 10 %, grossite < 6 %, tricalcium aluminate < 1 %, calcium sulfate "<1" (printed inside the component cell; the % column of that row is blank) *(SDS)*; organic carrier not identifiedSDS
- Presentation
- Ready-to-use syringe stored in an aluminium container; kits 1.2 g / 2.4 g *(brochure)* or 0.65 g / 2.4 g *(FAQ)*, see flagsMixed sources
- Mixing / working time
- No mixing; working time > 1 h at room temperature
- Initial setting
- ~4 h at 37 °C in vivo or in a moist environment
- Radiopacity (mm Al)
- IFU 8.4 mm Al; FAQ and quick start 8.1 mm Al, see flags
- pH
- ~10–12 mixed with water *(SDS)*; "initially high pH" *(FAQ)*Mixed sources
- Solubility (%)
- < 3 %
- Indications as labelled
- Vital pulp: indirect pulp cap · direct pulp cap · partial pulpotomy · cavity liner · base · pulpotomy · apexogenesis. Periradicular: perforation repair · resorption · obturation · apexification · root-end filling (12). "Other applications": complete endodontic obturation when applicable
- Primary-teeth labelling
- IFU: no explicit primary-tooth indication; primary-tooth pulpectomy contraindicated unless the successor is absent. Marketing: step-by-step placement in primary teeth, "for pediatric dentistry" *(brochure)*Brochure
- Contraindications
- Hypersensitivity to caustic (high-pH) solutions; primary-tooth pulpectomy unless the successor is absent
- Warnings and precautions
- Caustic; unset putty on skin or mucosa; keep sealed and recap immediately; do not overfill; non-sterile and cannot be sterilised; setting inhibited in acidic/infected sites; bleeding > 10 min suggests irreversible pulpitis; do not etch or bond directly to it *(brochure)*. "Does not discolor teeth"Brochure
- Restoration timing
- Restore immediately (washout resistant); the material keeps setting under the restoration for ~4 h *(brochure)*. Apexification: full-coverage restoration normally followsBrochure
EndoSequence BC RRM
Brasseler's premixed calcium-silicate family in three forms: an injectable paste with disposable tips, a putty (also sold as BC Pediatric Putty) in syringe or jar, and a Fast Set putty. Paste and putty are labelled to set in at least 2 hours under normal conditions and Fast Set in at least 10 minutes; the brochure quotes 20 minutes for Fast Set. The safety data sheets give a pH above 12. No working-time or radiopacity value is printed.
Indications as labelled
- Repair of root perforation
- Repair of root resorption
- Root-end filling
- Apexification
- Pulp capping (the directions cover indirect and direct capping)
Contraindications
- Known allergy to any ingredient
Warnings and precautions
- Unset material may irritate; do not use excessive force when applying
- Not tested in pregnant or nursing women
- Overfilling can cause sensitivity, foreign-body inflammation, sinus aspergillosis or nerve impingement
- Control bleeding first or the material may wash out
- No composite over unset material; no indirect pulp cap in irreversible pulpitis; do not sterilise
Restoration timing
Direct pulp cap: reinforced glass-ionomer core, observe for 4–6 weeks before the final composite. Indirect: final restoration once the glass ionomer has set. Perforation: glass-ionomer cap then complete the root canal treatment in one visit, or a moist pellet and a second visit. Apexification: backfill the same visit or revisit in a week.
Discolouration
The IFUs carry no discolouration statement; the brochure describes the material as non-staining and bismuth-free.
All labelled values
- Class
- Premixed calcium silicate in all three forms: Putty "based on a calcium silicate composition, which requires the presence of water to set and harden"; Paste "hydraulic premixed injectable BioAggregate paste"; Fast Set "hydraulic premixed bioceramic paste"
- Composition as listed
- Putty: calcium silicates, zirconium oxide, tantalum pentoxide, calcium sulfate (anhydrous), calcium phosphate monobasic, filler agents. Paste + Fast Set: same list with "calcium sulfate" (no "anhydrous"). SDS (Paste 4609 and Fast Set 4611, identical tables): tricalcium silicate 30.0–36.0 %, zirconium oxide 15.0–18.0 %, tantalum pentoxide 12.0–15.0 %, dicalcium silicate 9.0–13.0 %, calcium sulfate 3.0–8.0 %, fillers withheld (CBI). Brochure (Fast Set): lists calcium hydroxide; no calcium sulfate
- Presentation
- Paste: preloaded syringe + disposable BC Tips. Putty / Pediatric Putty: preloaded syringe or preloaded jar. Fast Set Putty: preloaded syringe (0.3 g per SDS/brochure)
- Mixing / working time
- No mixing; no working-time value stated (all three IFUs, identical wording under the heading "WORKING TIME")
- Final setting
- Undifferentiated "setting time" (not labelled initial/final): Paste and Putty ≥ 2 h; Fast Set ≥ 10 min "in normal conditions" — longer in extremely dry canals, and the IFU adds that inadequately dried canals may set quickly. Brochure: Fast Set "20 min"
- pH
- > 12 *(SDS, Paste and Fast Set)*; "+12 pH" *(brochure, Fast Set)*Mixed sources
- Indications as labelled
- Identical five in all three IFUs: repair of root perforation · repair of root resorption · root end filling · apexification · pulp capping (directions cover indirect and direct pulp capping)
- Primary-teeth labelling
- No primary-teeth indication in the list. All three IFUs carry a deciduous-teeth note under direct pulp capping; the 4610 IFU also names a "BC Pediatric Putty" (no separate pediatric directions)
- Contraindications
- Known allergy to any ingredient
- Warnings and precautions
- Unset material irritant; no excessive force; not tested in pregnancy/nursing; overfilling risks; control bleeding (washout); no composite over unset material; no indirect cap in irreversible pulpitis; do not sterilise. IFU: no discolouration statement. Brochure: "Non-Staining", bismuth-free
- Restoration timing
- Direct pulp cap: reinforced GIC core, observe 4–6 weeks before final composite. Indirect: final restoration once GIC is set. Perforation, single visit: GIC cap, then complete RCT; two visits: moist pellet, complete at second visit. Apexification: backfill same visit, or revisit in a week
- IFU document and revision
- Paste IFU 4609 REV 7.0 (2023-04-15); Putty/Pediatric Putty IFU 4610 REV 11.0 (2023-04-15); Fast-Set Putty IFU 4611 REV 7.0 (2023-04-15). Marker dropped the footers; revision lines come from pdftotext
TotalFill BC RRM
FKG's premixed, water-setting calcium-silicate line: a 1 g paste syringe, a 2.5 g putty jar and a 0.3 g Fast Set putty syringe. Working time is labelled at over 30 minutes; paste and putty set in at least 2 hours and Fast Set in about 20 minutes. Safety data sheets give a pH above 12; radiopacity is stated only qualitatively.
Indications as labelled
- Repair of root perforation
- Repair of root resorption
- Root-end filling
- Apexification
- Pulp capping (the directions cover indirect and direct capping)
Contraindications
- Known allergy to any ingredient
Warnings and precautions
- Unset material may irritate; do not use excessive force when applying
- Not tested in pregnant or nursing women
- Overfilling can cause sensitivity, foreign-body inflammation, sinus aspergillosis or nerve impingement
- Control bleeding first or the material may wash out
- Discard the BC Tips after each application; do not sterilise
- No composite over unset material; no indirect pulp cap in irreversible pulpitis
Restoration timing
Direct pulp cap: reinforced glass-ionomer core, observe for 4–6 weeks before the final composite. Indirect: final restoration once the glass ionomer has set. Perforation: glass-ionomer cap then complete the root canal treatment in one visit, or a moist pellet and a second visit. Apexification: backfill the same visit or revisit in a week.
Discolouration
The IFU carries no discolouration statement; the scientific overview only summarises a third-party study.
All labelled values
- Class
- Premixed calcium silicate ("bioceramic"), water-setting
- Composition as listed
- IFU (English part): no composition section. SDS (one table for all three forms): tricalcium silicate 30.0–36.0 %, zirconium oxide 15.0–18.0 %, tantalum pentoxide 12.0–15.0 %, dicalcium silicate 9.0–13.0 %, calcium sulfate 3.0–8.0 %, fillers withheld (CBI)
- Presentation
- BC RRM (paste): syringe, 1 g. BC RRM Putty: jar, 2.5 g. BC RRM Fast Set Putty: syringe, 0.3 g
- Mixing / working time
- No mixing; working time > 30 minutes
- Final setting
- Undifferentiated "setting time": BC RRM and Putty ≥ 2 h; Fast Set Putty ≈ 20 min
- pH
- > 12 *(SDS)*SDS
- Indications as labelled
- Repair of root perforation · repair of root resorption · root end filling · apexification · pulp capping (directions cover indirect and direct)
- Primary-teeth labelling
- No primary-teeth indication; deciduous-teeth note under direct pulp capping
- Contraindications
- Known allergy to any ingredient
- Warnings and precautions
- Unset material irritant; no excessive force; not tested in pregnancy/nursing; overfilling risks; control bleeding (washout); discard BC Tips; do not sterilise; no composite over unset material; no indirect cap in irreversible pulpitis. IFU: no discolouration statement. Scientific overview: third-party study summary only
- Restoration timing
- Direct pulp cap: reinforced GIC core, observe 4–6 weeks before final composite. Indirect: final restoration once GIC is set. Perforation: GIC cap then complete RCT (single visit); moist pellet, complete at second visit (two visits). Apexification: backfill same visit, or revisit in a week
- IFU document and revision
- B-4940A, REV 1. The English text names Innovative BioCeramix Inc. (Burnaby, Canada) with Emergo Europe; no revision date printed in the extracted text
iRoot BP Plus
Innovative BioCeramix's premixed calcium-silicate paste in a preloaded syringe or jar; the same chemistry family as the EndoSequence and TotalFill root-repair materials. Labelled to set in at least 2 hours under normal conditions, longer in very dry canals; the safety data sheet gives a pH above 12. No working-time or radiopacity value is printed.
Indications as labelled
- Repair of root perforation
- Repair of root resorption
- Root-end filling
- Apexification
- Pulp capping (the directions cover indirect and direct capping)
Contraindications
- Known allergy to any ingredient
Warnings and precautions
- Unset material may irritate; do not use excessive force when applying
- Not tested in pregnant or nursing women
- Overfilling can cause sensitivity, foreign-body inflammation, sinus aspergillosis or nerve impingement
- Control bleeding first or the material may wash out
- Do not sterilise; no composite over unset material; no indirect pulp cap in irreversible pulpitis
Restoration timing
Direct pulp cap: reinforced glass-ionomer core, observe for 4–6 weeks before the final composite. Indirect: final restoration once the glass ionomer has set. Perforation: glass-ionomer cap then complete the root canal treatment, in one or two visits. Apexification: backfill the same visit or revisit in a week.
Discolouration
No discolouration statement in the obtained documents.
All labelled values
- Class
- Premixed calcium silicate ("bioceramic"), water-setting
- Composition as listed
- IFU: calcium silicates, zirconium oxide, tantalum pentoxide, calcium sulfate (anhydrous), calcium phosphate monobasic, filler agents. SDS: tricalcium silicate 30.0–36.0 %, zirconium oxide 15.0–18.0 %, tantalum pentoxide 12.0–15.0 %, dicalcium silicate 9.0–13.0 %, calcium sulfate 3.0–8.0 %, fillers withheld (CBI)
- Presentation
- Preloaded syringe or preloaded jar; the IFU calls the material a "ready-to-use premixed bioceramic paste"
- Mixing / working time
- No mixing; no working-time value stated
- Final setting
- Undifferentiated "setting time": ≥ 2 h "in normal conditions" — longer in extremely dry canals; the IFU adds that inadequately dried canals may set quickly
- pH
- > 12 *(SDS)*SDS
- Indications as labelled
- Repair of root perforation · repair of root resorption · root end filling · apexification · pulp capping (directions cover indirect and direct)
- Primary-teeth labelling
- No primary-teeth indication; deciduous-teeth note under direct pulp capping
- Contraindications
- Known allergy to any ingredient
- Warnings and precautions
- Unset material irritant; no excessive force; not tested in pregnancy/nursing; overfilling risks; control bleeding (washout); do not sterilise; no composite over unset material; no indirect cap in irreversible pulpitis. No discolouration statement in the obtained documents
- Restoration timing
- Direct pulp cap: reinforced GIC core, observe 4–6 weeks before final composite. Indirect: final restoration once GIC is set. Perforation: GIC cap then complete RCT, or two visits. Apexification: backfill same visit, or revisit in a week
- IFU document and revision
- IFU 4610 REV 12.0, Rev Date 2023-05-15. Marker dropped the footer; revision line from pdftotext
CeraPutty
Meta Biomed's premixed, moisture-setting calcium-silicate putty in a polypropylene syringe sealed in an aluminium pouch (0.5 g and 1.0 g units). The IFU labels setting within 1 hour on the ISO 6876:2012 test, shorter in humid and longer in dry conditions; the leaflet quotes an initial set of 2 minutes and a final set of 20 minutes, radiopacity of 6.6 and a pH above 12.7. Bismuth-free, with zirconium dioxide as radiopacifier.
Indications as labelled
- Repair of root perforation
- Repair of root resorption (listed, but without directions)
- Root-end filling
- Apexification
- Pulp capping (not split into direct and indirect)
Contraindications
- Listed as "not known yet"; the warnings bar use in patients with a hypersensitivity history or an allergy to an ingredient
Warnings and precautions
- Specialist use only
- Not for patients with a history of hypersensitivity or an allergy to the ingredients
- Not for pregnant or lactating women (untested)
- Do not use excessive force; take a radiograph to confirm the seal
- Avoid eye and skin contact; wear gloves, mask and protective glasses
Restoration timing
No interval stated. Pulp capping: base of light-cured resin or glass ionomer, then the final composite. Perforation: base and final composite, then check hardening at the next visit and redo if unset. Apexification: moist pellet and temporary filling, check hardening at the next visit.
Discolouration
The IFU carries no discolouration statement; the leaflet says the bismuth-free formula with zirconium dioxide does not cause tooth discolouration.
All labelled values
- Class
- Premixed calcium silicate ("bioceramic") putty, moisture-setting
- Composition as listed
- IFU raw materials: tricalcium silicate, zirconium dioxide, dicalcium silicate, tricalcium aluminate (+ thickening agent). MSDS wt%: zirconium dioxide 30~35, tricalcium silicate 5~15, dicalcium silicate 1~10, tricalcium aluminate 25~40; thickening agent withheld. Leaflet: "approximately 65% of bioactive ingredients", "Resin-free"
- Presentation
- Preloaded polypropylene syringe in an aluminium pouch; pack list 0.5 g ×1, 1.0 g ×1, 0.5 g ×2; model codes CP10, CP05, CP052 are listed separately (code-to-pack mapping not stated)
- Mixing / working time
- No mixing; no working-time value stated
- Initial setting
- 2 min *(brochure)*; described as surface setting under a wet cotton pellet. IFU: not statedBrochure
- Final setting
- IFU: within 1 hour (ISO 6876:2012), an undifferentiated "setting time" — shorter in humid, longer in dry conditions. Leaflet: final 20 min *(brochure)*Brochure
- Radiopacity (mm Al)
- 6.6 *(brochure)*; a preceding symbol is garbled in extraction (see flag c). IFU: qualitative onlyBrochure
- pH
- SDS: > 12. Leaflet: > 12.72 (wet cotton pellet); 12.72 at 3 days, max 13.22 at 10 days *(brochure)*Brochure
- Indications as labelled
- Repair of root perforation · repair of root resorption · root end filling · apexification · pulp capping (general indication "Endodontic Treatment"). The IFU directions cover pulp capping, perforation, root end filling and apexification only (no resorption directions); pulp capping is not split into direct/indirect
- Contraindications
- "Not known yet" (but the Warnings section bars use in allergy / hypersensitivity history; see flag e)
- Warnings and precautions
- Specialist use only; no use with hypersensitivity history or ingredient allergy; not for pregnant/lactating women (untested); no excessive force; X-ray to confirm seal; avoid eye/skin contact; PPE. IFU: no tooth-discolouration statement. Leaflet: bismuth-free, "does not cause tooth discoloration"
- Restoration timing
- No interval stated. Pulp capping: base (light-cured resin or GIC), then final composite restoration (no wait given). Perforation: base and final composite, then check hardening at the next visit and redo if unset. Apexification: moist pellet + temporary filling; check hardening at the next visit
- IFU document and revision
- IFU DM-232-1, dated 2024-02-02 (revision history on the sheet: 2023-10-06 new registration; 2024-02-02 general-name change, model names added)
TheraCal LC
A light-cured, resin-modified calcium silicate in a single-paste syringe, placed in increments of no more than 1 mm on visibly moist dentine and cured layer by layer. The brochure gives a pH of 10–11 and the safety data sheet 10. No working, setting, radiopacity or strength values are printed in the obtained documents.
Indications as labelled
- Direct pulp capping of carious, mechanical and traumatic exposures
- Indirect pulp capping in deep preparations; protective liner, base or sealer under amalgam, Class I/II composites, other bases and cements
Contraindications
- No contraindications heading in the English IFU; a warning advises against use in patients with a history of severe allergic reaction to methacrylate resins
Warnings and precautions
- Contains methacrylate monomers: irritation and allergic reactions are possible
- Its basic nature needs protection from the oral environment; keep off enamel and cavity margins; isolate
- Control pulpal haemorrhage first; if it cannot be controlled, consider endodontic therapy instead
- Place on visibly moist dentine in increments of 1 mm or less
- Protective eyewear for patient and staff
Restoration timing
Immediately after light-curing each increment, place the adhesive, base or restoration.
Discolouration
No discolouration statement in the obtained documents.
All labelled values
- Class
- Light-cured resin-modified calcium silicate
- Composition as listed
- IFU: none listed. SDS: Portland cement 30–50 %, BisGMA 5–10 %, barium zirconate 1–5 % (+ silicon dioxide 1–5 % in EU SDS). Brochure: tri-calcium silicate particles in a hydrophilic monomer
- Presentation
- Single-paste syringe with disposable tips; 1 g syringes *(brochure)*Brochure
- pH
- 10–11 *(brochure)*; 10 *(SDS, paste)*Mixed sources
- Indications as labelled
- 1. Direct pulp capping (carious, mechanical, traumatic exposures). 2. Indirect pulp capping in deep preparations, protective liner, base or sealer: under amalgam; under Class I/II composites; under other bases; under cements; as alternative to calcium hydroxide, glass ionomer/RMGI, cavity varnish sealer, zinc phosphate, IRM/ZOE
- Contraindications
- No "Contraindications" heading in the English IFU; the closest statement is a warning: not recommended with a history of severe allergic reaction to methacrylate resins
- Warnings and precautions
- Methacrylate monomers (irritation, allergy); not for severe methacrylate allergy; basic nature — protect from oral environment, not on enamel/margins; isolation; control haemorrhage; place on visibly moist dentin; ≤ 1 mm increments; eyewear. No discolouration statement
- Restoration timing
- Immediately after light-curing each increment, place adhesive/base/restoration
- IFU document and revision
- IN-192R17, Rev. 6/24 (supersedes IN-192R16 Rev. 5/22)
TheraCal PT
A dual-cured, resin-modified calcium silicate in a dual-barrel auto-mix syringe, labelled primarily for pulpotomy. Working time is at least 45 seconds at 35 °C and the single setting time a maximum of 5 minutes at 35 °C, with a 10-second light cure. The brochure describes an alkaline pH without a number.
Indications as labelled
- Primary: pulpotomy
- Secondary: direct pulp capping of pulp exposures; protective liner (indirect pulp capping) and base under a variety of substrates
Contraindications
- No contraindications heading; a warning advises against use in patients with a history of severe allergic reaction to methacrylate resins
Warnings and precautions
- Contains methacrylate monomers; isolate and wear eyewear
- Patient history of pain influences suitability; control haemorrhage first
- Leave the mixing tip on the syringe until the next use
- Staining can occur when chlorhexidine and sodium hypochlorite are used together; rinse with saline between them
- Devitalising procedures such as formocresol may prevent secondary bridge formation
Restoration timing
Immediately after the 10-second light cure, place the adhesive, base or restoration.
Discolouration
The only staining statement concerns chlorhexidine used together with sodium hypochlorite, not the material itself.
All labelled values
- Class
- Dual-cured resin-modified calcium silicate
- Composition as listed
- IFU: none listed. SDS base: "SG-Mix Cement" 50–75 %, BisGMA 5–10 %, barium zirconate 1–5 %. SDS catalyst: BisGMA 10–30 %, TEGDMA 10–30 %, barium zirconate 5–10 %, ytterbium fluoride 1–5 %, benzoyl peroxide < 1 %. Brochure: synthetic Portland cement calcium silicate particles in a hydrophilic matrix
- Presentation
- Dual-barrel auto-mix syringe with mixing tips; 4 g syringe *(brochure)*Brochure
- Mixing / working time
- Auto-mix; working time minimum 45 s at 35 °C
- Final setting
- Maximum 5 min at 35 °C (IFU; single "setting time"); comparison sheet says "less than 5 minutes" *(brochure)*; light-cure 10 sBrochure
- pH
- No numeric pH stated; brochure states an "alkaline pH" qualitatively *(brochure)*; SDS base: no dataBrochure
- Indications as labelled
- Primary: pulpotomy. Secondary: pulp exposures (direct pulp capping); protective liner (indirect pulp capping) and base under a variety of substrates
- Contraindications
- No "Contraindications" heading; the closest statement is a warning: not recommended with a history of severe allergic reaction to methacrylate resins
- Warnings and precautions
- Methacrylate monomers; severe methacrylate allergy; isolation; history of pain; haemorrhage control; eyewear; proceed immediately; leave the dual-syringe mixing tip in place until the next application; staining when chlorhexidine and sodium hypochlorite are used together; devitalising procedures may prevent secondary bridge formation
- Restoration timing
- Immediately after 10 s light cure, place adhesive/base/restoration
- IFU document and revision
- IN-201R7 Rev. 5/22
Dycal
Not a calcium silicate: a two-paste, self-curing, radiopaque calcium hydroxide liner, kept here as the comparator the pulp-capping literature measures against. Mixed in equal volumes and set in about 2–3 minutes on the pad, faster in the mouth. The catalyst paste has a pH of 11.5 in the safety data sheet.
Indications as labelled
- Direct pulp capping
- Indirect pulp capping / protective barrier under restorative materials
Contraindications
- None known; hypersensitivity is listed under the warnings
Warnings and precautions
- Contains sensitising components
- Protect from the oral environment; keep off enamel and cavity margins
- Insufficient data as a base, filling, luting or root-canal repair material
- Control haemorrhage before placing; apply a thin layer
Restoration timing
After the complete set, place the adhesive, base or restoration; reassess pulp status at the next appointment.
Discolouration
No discolouration statement in the obtained documents.
All labelled values
- Class
- Two-component self-curing radiopaque calcium hydroxide liner
- Composition as listed
- Base: disalicylate ester of 1,3-butylene glycol, calcium phosphate, calcium tungstate, zinc oxide, iron oxide. Catalyst: calcium hydroxide, ethyl toluenesulfonamide, zinc sterate [sic — IFU spelling], titanium dioxide, zinc oxide, iron oxide
- Presentation
- Paste–paste, collapsible laminate tubes, shades ivory and dentin
- Mixing / working time
- Equal volumes (1.17 to 1.00 by weight); complete mixing within 10 s; working time not given numerically
- Final setting
- ≈ 2–3 min on the pad at 21 °C / 50 % RH (single "set" time); shorter in the mouth
- pH
- Catalyst paste pH 11.5 *(SDS)*; IFU: "essentially basic"SDS
- Indications as labelled
- Direct pulp capping · indirect pulp capping / protective barrier under restorative materials
- Contraindications
- None known (hypersensitivity listed under Warnings)
- Warnings and precautions
- Sensitising components; protect from oral environment, not on enamel/margins; insufficient data as base/filling/luting or root-canal repair; haemorrhage control; thin layer; no discolouration statement
- Restoration timing
- After complete set, place adhesive/base/restoration; pulp status at next appointment
- IFU document and revision
- 523001WEB (R 1/9/25); Basic UDI-DI ++D002BASE55
What the clinical evidence says
Eighty-six claims from twenty-nine guidelines and systematic reviews, read in full text. Each statement is EndoGuide's own summary; open the quote to see the sentence it rests on and the page it sits on.
The ESE 2019 position statement asks for a hydraulic calcium silicate cement directly on the pulp in every vital pulp treatment, with the definitive restoration placed immediately to limit micro-leakage.
Duncan HF 2019Quote from the full text
In all cases, a hydraulic calcium silicate cement should be placed directly onto the pulp tissue and the tooth definitively restored immediately to prevent further micro -leakage (Al -Hiyasat *et al* .
p. 13
The same statement notes that the available hydraulic calcium silicate cements share biology but differ chemically in ways that change radiopacity, setting time and the tendency to discolour the tooth.
Duncan HF 2019Quote from the full text
A range of hydraulic calcium silicate cements are available, which share similar biological properties, but exhibit chemical differences, which influences radiopacity, setting time and the potential to discolour the tooth (Parirokh *et al* .
p. 14
It records that hydraulic calcium silicates such as MTA have shown better histological and clinical outcomes than calcium hydroxide on the exposed pulp.
Duncan HF 2019Quote from the full text
Hydraulic calcium silicate materials, such as mineral trioxide aggregate (MTA), have demonstrated superior histological (Aeinehchi *et al* .
p. 14
The ESE 2023 S3 guideline gives a weak recommendation for either root canal treatment or full pulpotomy in permanent teeth with pulpitis and spontaneous pain.
Duncan HF 2023Quote from the full text
We suggest treatment with either root canal treatment or full pulpotomy
p. 33
The guideline recommends a meticulous aseptic technique for pulp exposure and pulpitis: dental dam, good light and magnification.
Duncan HF 2023Quote from the full text
including the use of dental dam, good light and magnifying devices
p. 24
For revitalisation, the guideline names tooth discolouration from bismuth-oxide-containing MTA as the most frequently reported adverse event.
Duncan HF 2023Quote from the full text
Revitalization: The most frequently reported adverse event was tooth discolouration due to bismuth oxide containing MTA.
p. 46
The AAE 2021 position statement reports success of 85–100 % at 1–2 years when MTA and other calcium silicate cements are used for vital pulp therapy in permanent teeth with irreversible pulpitis, against 43–92 % for calcium hydroxide, glass ionomer and resin-based materials.
American Association of Endodontists 2021Quote from the full text
When MTA and other CSCs are used for VPT procedures in permanent teeth with symptomatic or asymptomatic irreversible pulpitis, success rates range from 85-100% at 1-2 years.
p. 3
The AAE notes that newer calcium silicate generations bring faster setting and compositions modified to reduce discolouration.
American Association of Endodontists 2021Quote from the full text
The newer generations of CSCs do demonstrate improved setting times (72,73,74) including modified compositions that reduce tooth discoloration.
p. 3
For haemostasis, the AAE states that sodium hypochlorite can be used in direct contact with pulp tissue across a range of concentrations without compromising pulp integrity.
American Association of Endodontists 2021Quote from the full text
Although several hemostatic options are available, sodium hypochlorite can be used safely in direct contact with pulp tissue at various concentrations, from dilute solutions to full bottle strength, without compromising pulp integrity (30,46,47,48) Sodium hypochlorite has not been shown to adversely alter pulp cell recruitment, cytodifferentiation, and hard tissue deposition.
p. 3
The AAPD's guideline on vital pulp therapy in primary teeth recommended against calcium hydroxide for pulpotomy.
American Academy of Pediatric Dentistry 2024Quote from the full text
recommended against the use of calcium hydroxide for pulpotomy
p. 3
The AAPD reports that calcium silicate cements such as MTA and Biodentine have shown higher pulpotomy success than other materials.
American Academy of Pediatric Dentistry 2024Quote from the full text
Caries Lesions* recommended against the use of calcium hydroxide for pulpotomy.16 Recently, calcium silicate cements, such as MTA and biodentine, have shown increased success rates in pulpotomies compared to other materials.17 After the coronal pulp chamber is filled with
p. 3
In the Cvek pulpotomy section the AAPD warns that MTA may cause tooth discolouration.
American Academy of Pediatric Dentistry 2024Quote from the full text
MTA may cause tooth discoloration
p. 6
In cariously exposed permanent teeth, direct pulp capping with MTA outperformed calcium hydroxide at one year (OR 2.66) and at 2–3 years (OR 2.21), with no difference at six months.
Cushley S 2021Quote from the full text
As shown in **Figure 2,** there is no significant difference in the success rate of calcium hydroxide and MTA at 6 months, but MTA performed better than calcium hydroxide at 12 months (OR 2.66, 95% CI; 1.46 - 4.84, p=0.001) and 2-3 years (OR 2.21, 95% CI; 1.42 -3.44, p=0.0004).
p. 8
The same meta-analysis found no significant difference between MTA and Biodentine at any of its three time points.
Cushley S 2021Quote from the full text
There is no significant difference between the two materials at any of the three-time points or between the results of the randomised and the non-randomised studies at the one time-point when both are available (1 year).
p. 8
Its summary: calcium hydroxide success falls with longer follow-up while MTA and Biodentine stay reasonably stable.
Cushley S 2021Quote from the full text
In summary, the data gathered for this review suggest that the success of calcium hydroxide reduces with long-term follow up, while that of MTA and Biodentine remained reasonably stable.
p. 9
The authors caution that the Biodentine studies are limited by small samples compared with the MTA literature.
Cushley S 2021Quote from the full text
However, the available studies investigating Biodentine are limited by a small sample size compared to the studies of MTA with evidence of publication bias, the results for this material should therefore be interpreted with caution (Careddu & Duncan 2018).
p. 10
A 2024 network meta-analysis of 21 randomised trials found a 2–3 times higher failure rate for calcium hydroxide products than for MTA in vital pulp treatment over two years.
Komora P 2024Quote from the full text
Te current network meta-analysis showed solid statistical evidence for MTA over Ca(OH)2 products, such as Ca(OH)2 and Ca(OH)2LC, with a 2–3 times higher failure rate in VPT over two years.
p. 17
In that analysis Biodentine was not inferior to MTA in any treatment-modality subgroup.
Komora P 2024Quote from the full text
Te current meta-analysis showed that the clinical efcacy of Biodentine in VPT is not inferior to MTA in any subgroups of treatment modality, suggesting that it has an excellent alternative.
p. 18
TotalFill was likewise not inferior to MTA at each pooled follow-up, on fewer studies.
Komora P 2024Quote from the full text
Te network meta-analysis showed that Totalfll was not inferior to MTA at each follow-up in the pooled subgroups.
p. 18
TheraCal LC was inferior to MTA at 12 and 24 months, with odds ratios of 2.09 and 2.10; it had been used only for direct pulp capping in the included trials.
Komora P 2024Quote from the full text
Te hypothesis that the newer bioactive materials would be as efcient in VPT as MTA was partially rejected as TeraCalLC was inferior to MTA at 12 and 24 months by signifcant odds ratios of 2.09 and 2.10.
p. 18
The authors suggest Biodentine where aesthetics are mandatory, such as the anterior region.
Komora P 2024Quote from the full text
In cases where aesthetics are mandatory (in the anterior region), Biodentine could be a better alternative for VPT.
p. 19
A 2023 meta-analysis of randomised trials found MTA more successful than calcium hydroxide regardless of procedure (OR 2.94, 95 % CI 1.93–4.49).
Fasoulas A 2023Quote from the full text
### Subgroup analysis for treatment performed Regardless of the treatment performed, MTA did result in higher treatment success than CH (OR = 2.94, 95% CI: 1.93 −4.49), with the largest effect in DPC (OR = 3.10, 95% CI: 1.66 −5.79) (Figure [9](#page-14-0)).
p. 9
Its strong evidence in favour of MTA held only for direct pulp capping; the wide confidence intervals lowered confidence elsewhere.
Fasoulas A 2023Quote from the full text
There was strong evidence in favor of MTA only for the treatment of DPC.
p. 9
A 2022 meta-analysis found no difference between TheraCal LC and its controls for direct and indirect pulp capping in permanent teeth.
Argueta-Figueroa L 2022Quote from the full text
Discussion** The findings of the current meta-analyses of the effect of TheraCal LC on direct and indirect pulp capping in permanent teeth revealed no difference between this bioactive biomaterial and the controls.
p. 12
The same review reports more post-operative pain with TheraCal LC than with calcium hydroxide, MTA or Biodentine, especially after direct capping, without a drop in clinical success over the follow-up studied.
Argueta-Figueroa L 2022Quote from the full text
The evidence indicates that TheraCal LC causes more pain than self-cured calcium hydroxide, MTA, or Biodentine, especially in patients who underwent direct pulp capping.
p. 12
A 2026 meta-analysis supports TheraCal LC and other calcium silicates for indirect pulp capping, while for direct capping of mature teeth it points to MTA and Biodentine.
Mohamed MA 2026Quote from the full text
Overall, the evidence supports TheraCal LC and other calcium silicate materials (CSMs) as effective agents for indirect pulp capping, promoting robust dentinogenesis.
p. 16
The GRADE rating across the TheraCal LC trials was predominantly moderate certainty, held down by risk-of-bias concerns.
Mohamed MA 2026Quote from the full text
Despite a growing number of randomized controlled trials (RCTs) evaluating TheraCal LC as a pulp-capping material, the GRADE assessment revealed predominantly *moderate-certainty evidence* across all included studies.
p. 16
A 2020 review cites 92.5–97.96 % success at 9–10 years for pulp capping with MTA.
Kunert M 2020Quote from the full text
revealed 92.5–97.96% success for the teeth pulp-capped with MTA
p. 7
A 2026 meta-analysis found no clinically important difference in treatment success between resin-modified and conventional calcium silicate materials, at low overall certainty.
Cabrera-Fernández A 2026Quote from the full text
Taken together, although the evidence suggests no clinically important difference in treatment success between resin-modified and non-resin-modified calcium silicate-based materials, the overall certainty of evidence was rated as low.
p. 15
Dentine bridge formation at 360 days differed significantly (p = 0.006) in favour of the conventional calcium silicates.
Cabrera-Fernández A 2026Quote from the full text
reveals significant differences (*p* = 0.006) at 360 days, with conventional calcium silicate-based materials demonstrating clear superiority
p. 18
In the one pulpotomy trial of TheraCal PT, it showed lower success and poorer dentine bridge formation than Biodentine at 90, 180 and 360 days.
Cabrera-Fernández A 2026Quote from the full text
TheraCal PT showed lower overall success rates and poorer dentine bridge formation than Biodentine at all follow-up periods (90, 180, and 360 days) when used in pulpotomy procedures.
p. 20
The 2018 Cochrane review concludes that MTA may be the most efficacious medicament after pulpotomy of a primary tooth.
Smaïl-Faugeron V 2018Quote from the full text
The evidence suggests MTA may be the most efficacious medicament to heal the root pulp after pulpotomy of a deciduous tooth.
line 469
For direct pulp capping in primary teeth, the Cochrane review found too few studies and evidence of too low quality to interpret.
Smaïl-Faugeron V 2018Quote from the full text
Regarding direct pulp capping, the small number of studies and low quality of the evidence limited interpretation.
line 478
A 2020 systematic review of 41 papers calls MTA the gold standard for primary-tooth pulpotomy, with Biodentine promising and calcium hydroxide to be avoided.
Bossù M 2020Quote from the full text
Conclusions** Within the limitation of the present systematic review, MTA seemed to be the gold standard material in the pulpotomy of primary teeth.
p. 18
A 2025 meta-analysis of 14 trials found first- and second-generation bioceramics comparable in clinical and radiographic success for primary pulpotomies up to 24 months.
Albernaz Neves J 2025Quote from the full text
First- and second-generation bioceramics have comparable clinical and radiographic success rates in pulpotomies of primary teeth.
p. 12
A 2017 systematic review of in vitro studies found a strong staining potential for ProRoot MTA, MTA Angelus and Ortho MTA.
Możyńska J 2017Quote from the full text
The results clearly indicated a strong staining potential for ProRoot WMTA, A-MTA (Londrina, PR, Brazil), and Ortho MTA (BioMTA, Seoul, Korea).
p. 4
The materials with the smallest staining potential in the individual studies were Biodentine, Retro MTA, Portland cement and EndoSequence Root Repair Material.
Możyńska J 2017Quote from the full text
the materials with the smallest staining potential were Biodentine (Septodont, Saint Maur des Fosses, France), Retro MTA (BioMTA), Portland cement (PC), EndoSequence Root Repair Material (ERRM; Brasseler USA, Savannah, GA), Odontocem (Australian Dental Manufacturing, Brisbane, Australia), MM-MTA, and MTA Ledermix
p. 4
Newer materials using zirconium oxide as radiopacifier did not show a high staining potential; bismuth oxide in contact with collagen turns into a black precipitate.
Możyńska J 2017Quote from the full text
However, newer materials that contained zirconium oxide as a contrasting substance did not have high staining potential [(19).](#page-8-0) When bismuth oxide interacted with collagen, it was converted to a black precipitate [(29)](#page-8-0).
p. 6
Sodium hypochlorite residues react with bismuth and other heavy-metal oxides to form a black precipitate.
Możyńska J 2017Quote from the full text
When NaOCl came into contact with bismuth and other heavy metal oxides, a black precipitation appeared [(5, 9, 10, 29, 34)](#page-8-0).
p. 7
In the presence of blood, tooth colour changed by more than 15 % within 24 hours.
Możyńska J 2017Quote from the full text
In the presence of blood, tooth color changes by more than 15% in just 24 hours [(38).](#page-8-0) Blood significantly increases the value of DE; the amount of change depends on the type of material used and the passage of time.
p. 7
Two layers of a dentine bonding agent before MTA prevented the discolouration caused by white and grey MTA Angelus in one study.
Możyńska J 2017Quote from the full text
It is interesting that an application of 2 layers of a dentin bonding agent before using MTA could prevent tooth discoloration caused by either A-WMTA or A-GMTA [(8)](#page-8-0).
p. 7
Biodentine is not spotless in that literature: one study found a great staining potential after one year while others found none.
Możyńska J 2017Quote from the full text
Ramos et al [(22)](#page-8-0) showed that Biodentine had a great potential for tooth staining after 1 year.
p. 7
The colour change comes from a phase change of bismuth oxide to its black δ-phase.
Camilleri J 2026Quote from the full text
The change in colour is caused by a phase change and formation of the δ-phase, which is black (Camilleri et al. [2026)](#page-4-23).
p. 5
Torabinejad and colleagues report that recent work identifies bismuth oxide, not iron and manganese, as the major cause of MTA discolouration.
Torabinejad M 2018Quote from the full text
Iron and manganese were suggested as the elements responsible for the discolouration (Parirokh & Torabinejad 2010b); however, recent investigations have shown that bismuth oxide is the major culprit (Valles et al. 2013a,b, Berger et al. 2014, Marciano et al. 2014).
p. 14
In laboratory contact with sodium hypochlorite or water, Biodentine and Neo MTA Plus did not discolour, while MTA Plus showed a significantly larger colour change.
Torabinejad M 2018Quote from the full text
Biodentine and Neo MTA Plus did not have a discolouration effect in laboratory conditions in contact with NaOCl or water, whilst MTA Plus had a significantly larger discolouration change in comparison (Camilleri 2015).
p. 16
Residual sodium hypochlorite in dentinal tubules is proposed as the reason tooth-coloured ProRoot MTA discoloured when placed after that irrigant.
Torabinejad M 2018Quote from the full text
Residual NaOCl in dentinal tubules may be the reason for discolouration when tooth-coloured ProRoot MTA was placed following the irrigant (Voveraityte et al. 2017).
p. 16
Their summary lists environment, porosity, composition, blood contamination, bismuth oxide in an oxygen-free lit environment, certain irrigants and light among the factors behind discolouration.
Torabinejad M 2018Quote from the full text
In conclusion, the environment, porosity, chemical composition, contamination with blood, presence of bismuth oxide in an oxygen-free environment with light, use of some types of irrigants, fluorescent light and time of evaluation have an impact on the discolouration potential of BECs.
p. 17
In apexification, apical barrier formation took 3 ± 2.9 months with MTA against 7 ± 2.5 months with calcium hydroxide in one included trial.
Shaik I 2021Quote from the full text
The result showed that it took 3 ± 2.9 months for apical barrier formation in MTA groups and 7 ± 2.5 months in calcium hydroxide groups.
p. 3
A bioceramic apical barrier and MTA reached 93.3 % and 90 % success with no significant difference.
Shaik I 2021Quote from the full text
The success rate in both bioceramic and MTA was 93.3% and 90%, respectively, with no statistically significant difference.
p. 4
The review's conclusion: all three materials reach similar success, but MTA and EndoSequence BC RRM form the apical barrier significantly faster than calcium hydroxide.
Shaik I 2021Quote from the full text
However, MTA and Endosequence BCRRM were associated with a significantly shorter time to achieve apical barrier formation than the calcium hydroxide.
p. 5
A 2022 meta-analysis found MTA apexification and regenerative treatment with similar survival (RR 0.99, 95 % CI 0.93–1.05).
Panda P 2022Quote from the full text
However, a subgroup analysis observation was that apexification with MTA and REP exhibited a similar survival rate at RR 0.99, with 95% CI [0.93, 1.05], *p* = 0.76, I2 = 0%.
p. 23
In the same forest plot, calcium hydroxide apexification had a lower success rate than MTA apexification.
Panda P 2022Quote from the full text
In the same forest plot it was observed that the Ca(OH)2 apexification procedure had a low success rate compared to the MTA apexification procedure.
p. 23
Tooth discolouration was seen more after regenerative treatment than after apexification.
Panda P 2022Quote from the full text
Discoloration to the tooth was seen more in RET than in apexification
p. 29
A 2024 umbrella review finds regenerative treatment gives greater increases in root length and thickness than the other modalities.
Tewari N 2024Quote from the full text
Compared with the other treatment modalities, the RET resulted in greater increases in root length and thickness in the middle and apical thirds of the root.
p. 18
MTA apical plugs show high success in forming an apical barrier, but the evidence quality is weak (class IV).
Tewari N 2024Quote from the full text
MTA apical plugs showed high success rates in forming apical barriers. However, the quality of evidence was weak (Class IV) for both outcomes, and the majority of SRs exhibited low or critically low quality and high risk of bias.
p. 18
A 2015 meta-analysis of ten studies put the pooled success of non-surgical root perforation repair at 72.5 % (CI 61.9–81.0 %).
Siew K 2015Quote from the full text
The pooled overall success rate was estimated as 72.5% (CI, 61.9%–81.0%) for all repair materials included in these reports.
p. 7
When MTA was the repair material the figure was 80.9 % (CI 67.1–89.8 %), a difference the authors did not find statistically significant.
Siew K 2015Quote from the full text
The figure for repair using MTA material was 80.9% (CI, 67.1%–89.8%).
p. 8
The authors conclude that non-surgical repair can exceed 70 % success and may be the preferred first treatment, on a small clinical literature.
Siew K 2015Quote from the full text
On the basis of the evidence available to date, a relatively high success rate (more than 70%) may be achieved by nonsurgical repair for root perforations, suggesting it is a worthwhile attempt to save the affected tooth.
p. 9
In endodontic microsurgery with IRM, MTA, Super EBA or other calcium silicates as root-end filling, eleven studies (915 teeth) pooled to 94.42 % success.
Kohli MR 2018Quote from the full text
The combined sample size of all 11 studies in the EMS group was n = 915 with a weighted pooled success rate of 94.42% (95% CI, 0.9295–0.9590).
p. 4
Microsurgery had 2.89 times the odds of success of resin-based surgery with a shallow composite root-end filling.
Kohli MR 2018Quote from the full text
The odds ratio showed that EMS had 2.89 times the odds of success than RES (odds ratio = 2.892; 95% CI, 2.10753–4.00034).
p. 5
In a 2022 network meta-analysis, MTA (OR 5.62; 95 % CI 1.58–19.99), root repair material (OR 5.23) and Super EBA (OR 3.99) all outperformed gutta-percha at 12 months in the sensitivity analysis.
Chao Y 2022Quote from the full text
(MTA: OR, 5.62; 95% CI, 1.58e19.99; P-score, 0.88; RRM: OR, 5.23; 95% CI, 1.05e25.98; P-score, 0.74; Super EBA: OR, 3.99; 95% CI, 1.06e15.04; P-score, 0.54; reference material, GP).
p. 9
The authors place MTA first among root-end filling materials at the 12-month follow-up.
Chao Y 2022Quote from the full text
and Tsesis et al., our results suggest that MTA remains the best choice of root-end filling materials compared to the competitor materials, based
p. 10
In long-term follow-up the same analysis found no statistically significant difference in success between root-end filling materials.
Chao Y 2022Quote from the full text
Within the limitations of this study, there was no statistically significant difference for success rates between root-end filling materials in long-term follow-up group under our present evidence.
p. 11
The 2021 Cochrane review rates the evidence very uncertain: MTA versus IRM may make little or no difference to one-year success (RR 1.09, 95 % CI 0.97–1.22).
Ma X 2021Quote from the full text
Results suggested that there may be little to no effect of MTA compared to IRM on success rate at one year, but the evidence from two studies is very uncertain due to imprecision and high risk of bias.
line 2243
MTA versus premixed root repair material likewise may make little or no difference at one year (RR 1.00, 95 % CI 0.94–1.07), on very low-certainty evidence.
Ma X 2021Quote from the full text
Evidence also suggests that there may be little to no effect of MTA compared to RRM on success rate at one year, but the evidence from two studies is very uncertain due to imprecision and high risk of bias.
line 2254
Cochrane's conclusion: the limited evidence is insufficient to prefer any one retrograde filling material.
Ma X 2021Quote from the full text
There was insufficient evidence, from these single studies (at high risk of bias and mostly with small sample sizes), to determine differences on success rate at one year between the following comparisons: MTA versus Super-EBA, Super-EBA versus IRM, dentine-bonded resin composite versus glass ionomer cement, and glass ionomer cement versus amalgam.
line 2262
A 2025 meta-analysis of five microsurgery studies found every included study reporting no significant difference between EndoSequence root repair material and MTA.
Ibáñez-Aravena 2025Quote from the full text
All included studies reported no statistically significant differences between the ERRM and MTA groups (*p*>0.05).
p. 4
Its conclusion: newer bioceramics have not shown conclusive superiority over MTA for root-end sealing, though handling may favour them.
Ibáñez-Aravena 2025Quote from the full text
In conclusion, new bioceramics have not demonstrated conclusive superiority over MTA in root-end sealing in endodontic microsurgery.
p. 9
A 2026 meta-analysis of laboratory studies found no significant sealing difference between premixed and hand-mixed bioceramic root-end materials, with better marginal adaptation for premixed products.
Hattab 2026Quote from the full text
Within the limitations of laboratory-based evidence, premixed and manually mixed bioceramic root-end filling materials demonstrated no statistically significant difference in sealing ability, while premixed formulations exhibited significantly superior marginal adaptation.
p. 9
The authors caution that the sealing confidence interval spans both directions, so the absence of a difference is not evidence of equivalence.
Hattab 2026Quote from the full text
The confidence interval surrounding the pooled effect estimate encompasses values favoring either group, indicating statistical imprecision and the potential for a type II error.
p. 8
In a fluid-filtration model no significant leakage was seen when at least 3 mm of MTA remained after root-end resection.
Parirokh M 2010Quote from the full text
No significant leakage was observed when at least 3 mm of MTA remained after root-end resection. However, the authors reported significantly more leakage when 2 mm or less thickness of MTA remained after root-end resection [(27)](#page-8-0).
p. 2
The same review gives a final setting time of 24–83 minutes for MTA Angelus against 228–261 minutes for ProRoot MTA.
Kunert M 2020Quote from the full text
MTA Angelus was developed, offering the advantage of reduced final setting time—24–83 min
p. 5
It also notes that despite short labelled setting times, studies found adequate surface properties only after at least seven days, and that MTA keeps maturing up to a year.
Kunert M 2020Quote from the full text
studies showed adequate setting only after at least 7 days to acquire proper surface properties
p. 9
ProRoot MTA is 80 % Portland cement and 20 % bismuth oxide.
Camilleri J 2026Quote from the full text
ProRoot MTA is composed of 80% Portland cement and 20% bismuth oxide (Camilleri et al. [2005)](#page-4-0).
p. 1
Camilleri's 2026 classification sorts hydraulic cements by whether they release calcium hydroxide, whether the vehicle is water or an alternative, and whether they set on their own or need environmental moisture.
Camilleri J 2026Quote from the full text
Irrespective of the cement chemistry, the cements are either calcium hydroxide releasing or not, the vehicle is water or alternative, and the additives are cementitious or non-cementitious.
p. 1
Acid etching over a hydraulic cement should be kept to a minimum to avoid weakening its surface.
Camilleri J 2026Quote from the full text
The use of acid etching solutions should be kept to a minimum to avoid weakening the surface of the hydraulic cement when used to protect the pulp or as a barrier protecting the newly regenerated tissues (Camilleri [2013](#page-4-8)).
p. 4
Bismuth oxide at 20 % replacement is an effective radiopacifier but unstable, and it led to tooth discolouration.
Camilleri J 2026Quote from the full text
MTA included bismuth oxide, which was an effective radiopacifier when used as 20% replacement of the cement. Bismuth oxide was shown to be unstable and led to tooth discolouration.
p. 4
Alternative radiopacifiers are less radiopaque than bismuth oxide, so a higher percentage is needed for similar radiopacity.
Camilleri J 2026Quote from the full text
Alternative radiopacifiers are less radiopaque than bismuth oxide, and a higher percentage is required to result in similar radiopacity as bismuth containing materials (Camilleri and Gandolfi [2010;](#page-4-13) Húngaro Duarte et al. [2009)](#page-5-32).
p. 5
Replacing bismuth oxide with calcium tungstate or zirconium oxide is the first of the modifications reviewed; MTA HP and other newer calcium silicate cements took that route.
Duarte MAH 2018Quote from the full text
The first one is the replacement of bismuth oxide with calcium tungstate or with zirconium oxide.16 MTA HP and other new calcium silicate cements such as Biodentine and BC Sealer change the radiopacifying agent into calcium tungstate or zirconium oxide.
p. 2
Blood contamination changes the morphology of set MTA and reduces its calcium-ion release.
Duarte MAH 2018Quote from the full text
Contamination of MTA with blood affects the morphology of the set material and reduces the release of calcium ions.9,38 Furthermore, blood can change the color of the material and interfere in radiopacity over time.11
p. 2
A large amount of water increases both the setting time and the solubility of MTA.
Duarte MAH 2018Quote from the full text
A large amount of water increases both the setting time and solubility of MTA.
p. 2
Parirokh and Torabinejad's 2010 review gives the classic mix as 3:1 powder to sterile water and a mean setting time of 165 ± 5 minutes.
Parirokh M 2010Quote from the full text
MTA is prepared by mixing its powder with sterile water in a 3:1 powder-to-liquid ratio [(39)](#page-9-0). The mean setting time of MTA is 165 - 5 minutes, which is longer than amalgam, Super EBA, and intermediate restorative material (IRM) [(11).](#page-8-0)
p. 2
MTA's compressive strength is significantly lower than amalgam, IRM and Super EBA at 24 hours; by three weeks the gap to Super EBA closes.
Parirokh M 2010Quote from the full text
The compressive strength of MTA is significantly less than that of amalgam, IRM, and Super EBA after 24 hours. However, after 3 weeks, there is no significant difference between Super EBA, IRM, and MTA in terms of compressive strength [(11).](#page-8-0)
p. 3
The review relays a suggestion to postpone acid-etch composite restoration for at least 96 hours after MTA placement.
Parirokh M 2010Quote from the full text
The investigators suggested that restoration with acid-etch composite after MTA placement should be postponed for at least 96 hours [(73).](#page-9-0)
p. 3
MTA's pH is 10.2 after mixing and rises to 12.5 at three hours.
Parirokh M 2010Quote from the full text
The pH value of MTA is 10.2 after mixing. This value rises to 12.5 at 3 hours [(11)](#page-8-0).
p. 4
Mean radiopacity for MTA has been reported at 7.17 mm of aluminium-equivalent thickness.
Parirokh M 2010Quote from the full text
The mean radiopacity for MTA has been reported at 7.17 mm of an equivalent thickness of aluminum [(11)](#page-8-0).
p. 4
References
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- Duncan HF, Kirkevang LL, Peters OA, El-Karim I, Krastl G, Del Fabbro M, Chong BS, Galler KM, Segura-Egea JJ, Kebschull M (2023). Treatment of pulpal and apical disease: the European Society of Endodontology (ESE) S3-level clinical practice guideline. guideline. Int Endod J. https://doi.org/10.1111/iej.13974
- American Association of Endodontists (2021). AAE Position Statement on Vital Pulp Therapy. guideline. AAE.
- American Academy of Pediatric Dentistry (2024). Pulp therapy for primary and immature permanent teeth (best practices). guideline. AAPD Reference Manual.
- Cushley S, Duncan HF, Lappin MJ, Chua P, Elamin AD, Clarke M, El-Karim IA (2021). Efficacy of direct pulp capping for management of cariously exposed pulps in permanent teeth: a systematic review and meta-analysis. systematic review and meta-analysis. Int Endod J. https://doi.org/10.1111/iej.13449
- Komora P, Vámos O, Gede N, Hegyi P, Kelemen K, Galvács A, Varga G, Kerémi B, Vág J (2024). Comparison of bioactive material failure rates in vital pulp treatment of permanent matured teeth: a systematic review and network meta-analysis. systematic review and meta-analysis. Sci Rep. https://doi.org/10.1038/s41598-024-69367-7
- Fasoulas A, Keratiotis G, Spineli L, Pandis N, De Bruyne MAA, De Moor RJG, Meire MA (2023). Comparative efficacy of materials used in patients undergoing pulpotomy or direct pulp capping in carious teeth: a systematic review and meta-analysis. systematic review and meta-analysis. Clin Exp Dent Res. https://doi.org/10.1002/cre2.767
- Argueta-Figueroa L, Jurado CA, et al. (2022). Clinical efficacy of biomimetic bioactive biomaterials for dental pulp capping: a systematic review and meta-analysis. systematic review and meta-analysis. Biomimetics. https://doi.org/10.3390/biomimetics7040211
- Mohamed MA, Waly R, Mahmoud S, Fayyad AA, Azab A, Alamoush RA, Abozaid D (2026). Efficacy of TheraCal as pulp capping material in permanent dentition: a systematic review and meta-analysis. systematic review and meta-analysis. BMC Oral Health. https://doi.org/10.1186/s12903-026-09008-9
- Cabrera-Fernández A, Dominguez-Dominguez L, Pérez-Pérez A, Santos JMM, Díaz-Cuenca A, Torres-Lagares D, Sequeira DB, Segura-Egea JJ, Martín-González J (2026). Clinical and radiographic outcomes of vital pulp therapy using resin-modified versus conventional calcium silicate-based materials: a systematic review and meta-analysis. systematic review and meta-analysis. J Funct Biomater. https://doi.org/10.3390/jfb17010032
- Kunert M, Lukomska-Szymanska M (2020). Bio-inductive materials in direct and indirect pulp capping: a review article. narrative review. Materials (Basel). https://doi.org/10.3390/ma13051204
- Smaïl-Faugeron V, Glenny AM, Courson F, Durieux P, Muller-Bolla M, Fron Chabouis H (2018). Pulp treatment for extensive decay in primary teeth. systematic review and meta-analysis. Cochrane Database Syst Rev. https://doi.org/10.1002/14651858.CD003220.pub3
- Bossù M, Iaculli F, Di Giorgio G, Salucci A, Polimeni A, Di Carlo S (2020). Different pulp dressing materials for the pulpotomy of primary teeth: a systematic review of the literature. systematic review. J Clin Med. https://doi.org/10.3390/jcm9030838
- Albernaz Neves J, Bandeira Lopes L, Alves Duarte M, Mendes JJ, Pimentel T (2025). Systematic review and meta-analysis of first and second generation bioceramic materials in primary dentition pulpotomies. systematic review and meta-analysis. Sci Rep. https://doi.org/10.1038/s41598-025-00868-9
- Możyńska J, Metlerski M, Lipski M, Nowicka A (2017). Tooth discoloration induced by different calcium silicate-based cements: a systematic review of in vitro studies. systematic review. J Endod. https://doi.org/10.1016/j.joen.2017.04.002
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- Chao Y, et al. (2022). Effectiveness of different root-end filling materials in modern surgical endodontic treatment: a systematic review and network meta-analysis. systematic review and meta-analysis. J Dent Sci. https://doi.org/10.1016/j.jds.2022.05.013
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Frequently asked questions
01Which of these cements are labelled for pulpotomy of primary teeth?
Which of these cements are labelled for pulpotomy of primary teeth?
Short answer
ProRoot MTA labels pulpotomy of primary teeth in the child and adolescent age bands; MTA Flow labels a primary-dentition vital pulpotomy; Biodentine XP labels crown and pulp indications for temporary teeth from two years.
- 01NeoMTA 2 and NeoPUTTY are marketed for paediatric use and labelled as non-discolouring in primary teeth, but their IFUs contraindicate primary-tooth pulpectomy unless the successor is absent.
- 02The EndoSequence, TotalFill and iRoot IFUs carry only a deciduous-teeth note under direct pulp capping.
02Which cements say they do not discolour teeth, and which warn that they might?
Which cements say they do not discolour teeth, and which warn that they might?
Short answer
ProRoot MTA's EU IFU lists slight discolouration as a possible adverse reaction, and MTA Angelus warns that the grey version may stain in light-exposed areas.
- 01Products that replaced bismuth oxide state the opposite: MTA Angelus White, MTA Repair HP (calcium tungstate), NeoMTA 2 and NeoPUTTY (tantalum oxide) and, in brochures rather than IFUs, Bio-C Repair, EndoSequence BC RRM and CeraPutty (zirconium).
- 02Biodentine, Biodentine XP, TheraCal, MTA Flow, TotalFill and iRoot make no discolouration statement in their IFUs.
03Why do the setting times look so different between products?
Why do the setting times look so different between products?
Short answer
Because the documents measure different things.
- 01Biodentine prints 12 minutes from the start of mixing; NeoMTA 2 separates an initial set of 14 minutes from a final set of 1 h 45 min; the premixed putties print a minimum of 2 hours "in normal conditions" and warn that dry canals set slower and inadequately dried canals faster; CeraPutty cites the ISO 6876:2012 test.
- 02Only values with a named test and a named endpoint can be compared directly.
04Can a composite go straight onto the cement?
Can a composite go straight onto the cement?
Short answer
The resin-modified TheraCal products are restored immediately after light-curing.
- 01NeoMTA 2 and NeoPUTTY are labelled washout-resistant and restored immediately.
- 02The premixed putties from Brasseler, FKG and IBC forbid composite over unset material and route direct pulp caps through a reinforced glass-ionomer core with a 4–6 week observation; Bio-C Repair asks for glass ionomer and a 4–6 week wait; Biodentine and Biodentine XP allow enamel restoration once the set is complete, or a second session up to six months later.
05What does an acidic or infected site do to these cements?
What does an acidic or infected site do to these cements?
Short answer
Angelus, Ultradent and NuSmile all print the same warning in different words: the hydration reaction is inhibited at an acidic pH, so the material is to be used only after the acute phase or infection is controlled.
- 01MTA Flow adds that its antimicrobial action is limited.
- 02Biodentine XP adds that water contamination slows the set.
Related guides
Sources
- ProRoot MTA — NAM: END-IFU-PROROOT-MTA-V06-WEB-NAM-EN-2025-01. EUR: REF. A0405, Basic UDI-DI ++D716MTA012K; version/date carried only in the file stem (V05, 2025-08)
- MTA Angelus — Documents: **IFU** = `mta-angelus-ifu-multilang-eng-1050824-2025-01` (EN section {3}–{5}) · **TSP** = `mta-angelus-technical-scientific-profile-en-v1.000-2024-08-16` · **LINE** = `angelus-mta-line-folder-en` (MTA Angelus pages {28}–{37}; the rest of this folder covers MTA Repair HP and MTA-Fillapex).
- MTA Repair HP — Document code 1050843; issue date 10/02/2024 (date format not specified in the document)
- MTA Flow — 1008116AR01, dated 012020 (© 2020)
- NeoMTA 2 — Documents: **IFU** = `neomta-2-ifu-45-multilang-rev4` (English on {0}) · **QS** = `neomta-products-quick-start-ifu-36-multilang-rev5` (English {0}) · **FAQ** = `neomta-products-faq-ifu-60-en-rev0` · **SDS-P** = `neomta-2-powder-sds8-en-rev2-2020-04-06` · **SDS-GEL** = `neomta-2-gel-sds7-en` · **BROCH** = `neoputty-neomta-2-brochure-en` · **PSHEET** = `neoputty-neomta-2-product-sheet-en`.
- Biodentine — US IFU (EN/FR/ES), no document title/revision line beyond the manufacturer code string
- Biodentine XP — EU/UK multilingual cartridge IFU (Basic UDI-DI 37601407000004G9); no revision or date string in the extracted text — "2024" is from the file stem only. US IFU: no revision string
- Bio-C Repair — Documents: **IFU** = `bio-c-repair-ifu-multilang-eng-105038632-2025-10` (EN section {3}–{8}) · **TSP** = `bio-c-repair-technical-scientific-profile-en-v2.001-2024-08-16` · **FOLDER** = `bio-c-repair-folder-en-v1.002-2024-09-09`.
- NeoPUTTY — Documents: **IFU** = `neoputty-ifu-55-multilang-rev4` (English on {0}) · **FAQ** = `neoputty-faq-ifu-61-en-rev2` · **QS** = `neoputty-quickstart-mkt-nsnppb-rev0` (the "Pulpotomy Playbook" sheet) · **PSHEET** = `neoputty-product-sheet-en` (the "rethink your pulpotomy protocol" sheet: literature and testimonials, no specification values) · **SDS** = `neoputty-sds18-en-rev1-2021-10-28` · **BROCH** = `neoputty-neomta-2-brochure-en` · **PSHEET2** = `neoputty-neomta-2-product-sheet-en`.
- EndoSequence BC RRM — Paste IFU 4609 REV 7.0 (2023-04-15); Putty/Pediatric Putty IFU 4610 REV 11.0 (2023-04-15); Fast-Set Putty IFU 4611 REV 7.0 (2023-04-15). Marker dropped the footers; revision lines come from pdftotext
- TotalFill BC RRM — B-4940A, REV 1. The English text names Innovative BioCeramix Inc. (Burnaby, Canada) with Emergo Europe; no revision date printed in the extracted text
- iRoot BP Plus — IFU 4610 REV 12.0, Rev Date 2023-05-15. Marker dropped the footer; revision line from pdftotext
- CeraPutty — IFU DM-232-1, dated 2024-02-02 (revision history on the sheet: 2023-10-06 new registration; 2024-02-02 general-name change, model names added)
- TheraCal LC — IN-192R17, Rev. 6/24 (supersedes IN-192R16 Rev. 5/22)
- TheraCal PT — IN-201R7 Rev. 5/22
- Dycal — 523001WEB (R 1/9/25); Basic UDI-DI ++D002BASE55
Educational content
Values are copied from the documents; a cell reading "not stated" means the obtained documents carry no such figure, not that the property is unknown.
Reviewed by
Uzm. Dt. Levent Yüksel
DDS · Endodontist
Endodontist — DDS, Hacettepe University; endodontics specialty training, Ankara University. 10+ years of clinical experience. Sole author and reviewer of EndoGuide content.