Deep CariesPhase 4NCT06683833
Comparison Between Egyptian MTA, Biodentine Versus Calcium Hydroxide as Indirect Pulp Capping Materials In Permanent Teeth
A Phase 4 study testing Egyptian MTA, Biodentine and Calcium Hydroxide (Ca(OH)2) in people with Deep Caries and Indirect Pulp Capping, run by Cairo University at 1 site in Egypt.
Trial summary
Compare the clinical performance and patient satisfaction of Egyptian MTA, Biodentine versus Calcium Hydroxide as indirect pulp capping materials in permanent teeth Read more about this study
- Who is it for?
- Ages 22 to 45 years
- Conditions the study is for
- Deep Caries, Indirect Pulp Capping, Mineral Trioxide Aggregate (MTA)
- What is being tested?
- Egyptian MTA, Biodentine and Calcium Hydroxide (Ca(OH)2)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Sep 2025to 3 Jul 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult patients aged 22: 45 years old.
- Males or females.
- Patients with vital teeth with deep carious lesions.
- Patients in good general health.
- Good oral hygiene.
- Co-operative patients who show interest to participate in the study.
Who cannot join
- Patients with systemic diseases.
- Patients with known allergic or adverse reaction to the tested materials.
- Patients with bad oral hygiene.
- Patient who frequently use analgesic or any drugs that could mask the pain.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
El Monira General Hospital
Cairo
El Monira General Hospital, 0020223947206
About this study
Official title: Comparative Analysis of Egyptian MTA, Biodentine, and Calcium Hydroxide as Indirect Pulp Capping Materials in Permanent Teeth. (A 6m Randomized Clinical Trial)
Compare the clinical performance and patient satisfaction of Egyptian MTA, Biodentine versus Calcium Hydroxide as indirect pulp capping materials in permanent teeth
Read the detailed description
Vital pulp treatments (VPTs) represent a group of minimally invasive treatments intended to preserve the health of all or part of the dental pulp. These treatments include a spectrum of modalities including indirect pulp capping as first option, direct pulp capping and pulpotomy (partial or complete).
Indirect pulp capping (IPC) has been proposed as a conservative pulp therapy for several decades. It is a technique for deep caries management without any features of pulp degeneration.This stimulates tertiary dentin formation, avoiding pulp exposure and maintaining pulp vitality. Cases of indirect pulp capping in deep cavities are those where the residual dentin thickness is equal or less than 0.5 mm, the number and size of the "open" dentinal tubules are such that communication with the pulp parenchyma is comparable to that of a true exposure.
Ideal pulp capping material should maintain pulpal vitality and stimulate reparative dentin formation. These materials should possess certain properties such as biocompatibility, bioactivity, radiopacity, insolubility, dimensional stability, and adequate adhesive ability to both the dentin and to the restorative materials. It should also release remineralizing ions, provide bacterial seal, prevent secondary caries, should have bactericidal or bacteriostatic activity against the causative pathogens, and promote the formation of mineralized tissue
- Conditions
- Deep Caries, Indirect Pulp Capping, Mineral Trioxide Aggregate (MTA), Calcium Hydroxide, Biodentine, Patient Reported Outcome Measures
- Being tested
- Egyptian MTA, Biodentine, Calcium Hydroxide (Ca(OH)2)
- Keywords
- Deep caries, Indirect pulp capping, Mineral trioxide aggregate (MTA), Calcium hydroxide, Biodentine, Patient reported outcomes measures (PROMS), Randomized clinical trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Egyptian MTADrug
- Complete caries removal from the cavity.
- The liquid of Egyptian MTA (Toothmate) will be mixed with powder according to the manufacturers' instructions.
- The capping materials will be placed with the passive application on the deepest part of the cavity. Only light pressure will be applied on the MTA mixture using a wet cotton pellet to ensure adaptation of the material onto the dentin.
- A light-cured glass ionomer cement base will be applied in the cavity .
- Selective enamel etching will be applied on enamel only.
- The one-bottle universal adhesive system bond will be applied on enamel and dentine.
- A Nano hybrid composite resin material will then be incrementally inserted into the cavities.
BiodentineDrug
- Complete caries removal from the cavity.
- Gently tapping a capsule of Biodentine (Septodont) on a hard surface to loosen the powder, then opening the capsule, Detaching a single-dose container of liquid and gently tapping on the sealed cap to force all the liquid down the container, Twisting cap to open, Then Pouring 5 drops from the single-dose container into the capsule, Then Closing the capsule and Placing it on a mixing device for 30 seconds, Then Collecting Biodentine with the instrument supplied in the box.
- The capping materials will be placed with the passive application on the deepest part of the cavity.
- A light-cured glass ionomer cement base will be applied in the cavity .
- Selective enamel etching will be applied on enamel only.
- The one-bottle universal adhesive system bond will be applied on enamel and dentine.
- A Nano hybrid composite resin material will then be incrementally inserted into the cavities.
Calcium Hydroxide (Ca(OH)2)Drug
- Complete caries removal from the cavity.
- According to the manufacturers' instructions, Dispensing equal volumes of base and catalyst pastes on the parchment paper pad provided. Using a Dycal (Dentsply) Liner applicator, stirring immediately to mix thoroughly until a uniform color is achieved, complete mixing occurs within 10 seconds, using the ball-pointed Dycal Liner applicator or similar instrument, the mix will be placed directly on the cavity.
- The capping materials will be placed with the passive application on the deepest part of the cavity.
- A light-cured glass ionomer cement base will be applied in the cavity .
- Selective enamel etching will be applied on enamel only.
- The one-bottle universal adhesive system bond will be applied on enamel and dentine.
- A Nano hybrid composite resin material will then be incrementally inserted into the cavities.
| Study group | Role | What they receive |
|---|---|---|
| Egyptian MTA | Experimental | * Complete caries removal from the cavity.
* The liquid of Egyptian MTA (Toothmate) will be mixed with powder according to the manufacturers' instructions.
* The capping materials will be placed with the passive application on the deepest part of the cavity. Only light pressure will be applied on the MTA mixture using a wet cotton pellet to ensure adaptation of the material onto the dentin.
* A light-cured glass ionomer cement base will be applied in the cavity .
* Selective enamel etching will be applied on enamel only.
* The one-bottle universal adhesive system bond will be applied on enamel and dentine.
* A Nano hybrid composite resin material will then be incrementally inserted into the cavities. Receives: Drug: Egyptian MTA |
| Biodentine | Experimental | * Complete caries removal from the cavity.
* Gently tapping a capsule of Biodentine (Septodont) on a hard surface to loosen the powder, then opening the capsule, Detaching a single-dose container of liquid and gently tapping on the sealed cap to force all the liquid down the container, Twisting cap to open, Then Pouring 5 drops from the single-dose container into the capsule, Then Closing the capsule and Placing it on a mixing device for 30 seconds, Then Collecting Biodentine with the instrument supplied in the box.
* The capping materials will be placed with the passive application on the deepest part of the cavity.
* A light-cured glass ionomer cement base will be applied in the cavity .
* Selective enamel etching will be applied on enamel only.
* The one-bottle universal adhesive system bond will be applied on enamel and dentine.
* A Nano hybrid composite resin material will then be incrementally inserted into the cavities. Receives: Drug: Biodentine |
| Calcium Hydroxide | Active comparator | * Complete caries removal from the cavity.
* According to the manufacturers' instructions, Dispensing equal volumes of base and catalyst pastes on the parchment paper pad provided. Using a Dycal (Dentsply) Liner applicator, stirring immediately to mix thoroughly until a uniform color is achieved, complete mixing occurs within 10 seconds, using the ball-pointed Dycal Liner applicator or similar instrument, the mix will be placed directly on the cavity.
* The capping materials will be placed with the passive application on the deepest part of the cavity.
* A light-cured glass ionomer cement base will be applied in the cavity .
* Selective enamel etching will be applied on enamel only.
* The one-bottle universal adhesive system bond will be applied on enamel and dentine.
* A Nano hybrid composite resin material will then be incrementally inserted into the cavities. Receives: Drug: Calcium Hydroxide (Ca(OH)2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical assessment of treatment success
Pulp response to different stimuli by thermal and electrical pulp tests. When tooth normally responds to thermal and electrical pulp tests = success When tooth doesn't respond to thermal and electrical pulp tests = failure
Measured: T( Time) T0( base line)= one week after , T2= 3 months , T3= 6 months
Secondary outcomes (2)
Clinical assessment of pain
Patient reported outcome measures by visual analogue scale visual analogue scale is used to describe the pain by patients themselves in scores as ( 0: no pain ) \& (7-10 : Severe pain)
Measured: T( time) T0( baseline )= 1 week after, T1= 3 months, T2= 6 months
Patient satisfaction with the treatment
Patient reported outcome measure by 4- point likert scale 4- point likert scale used to describe patient satisfaction with the treatment as " (a) yes, very satisfied" \& " (d) not all satisfied"
Measured: T( time) T0= 1 week after, T1= 3 months , T2= 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start3 Sep 2025
- Primary completion3 May 2026 (estimated)
- Study completion3 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep CariesStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Talaat Mostafa Elsorogy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06683833
- Sponsor's protocol ID
- operative 2
- Status last verified
- Mar 2026
- First submitted
- 8 Nov 2024
- Last updated
- 18 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Analysis of Egyptian MTA, Biodentine, and Calcium Hydroxide as Indirect Pulp Capping Materials in Permanent Teeth. (A 6m Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT06683833
- Acronym / sponsor ID
- operative 2
- Conditions
- Deep Caries, Indirect Pulp Capping, Mineral Trioxide Aggregate (MTA), Calcium Hydroxide, Biodentine, Patient Reported Outcome Measures
- Keywords
- Deep caries, Indirect pulp capping, Mineral trioxide aggregate (MTA), Calcium hydroxide, Biodentine, Patient reported outcomes measures (PROMS), Randomized clinical trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 3 Sep 2025 (actual)
- Primary completion
- 3 May 2026 (estimated)
- Study completion
- 3 Jul 2026 (estimated)
- First posted
- 12 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Compare the clinical performance and patient satisfaction of Egyptian MTA, Biodentine versus Calcium Hydroxide as indirect pulp capping materials in permanent teeth
Detailed description
Vital pulp treatments (VPTs) represent a group of minimally invasive treatments intended to preserve the health of all or part of the dental pulp. These treatments include a spectrum of modalities including indirect pulp capping as first option, direct pulp capping and pulpotomy (partial or complete).
Indirect pulp capping (IPC) has been proposed as a conservative pulp therapy for several decades. It is a technique for deep caries management without any features of pulp degeneration.This stimulates tertiary dentin formation, avoiding pulp exposure and maintaining pulp vitality. Cases of indirect pulp capping in deep cavities are those where the residual dentin thickness is equal or less than 0.5 mm, the number and size of the "open" dentinal tubules are such that communication with the pulp parenchyma is comparable to that of a true exposure.
Ideal pulp capping material should maintain pulpal vitality and stimulate reparative dentin formation. These materials should possess certain properties such as biocompatibility, bioactivity, radiopacity, insolubility, dimensional stability, and adequate adhesive ability to both the dentin and to the restorative materials. It should also release remineralizing ions, provide bacterial seal, prevent secondary caries, should have bactericidal or bacteriostatic activity against the causative pathogens, and promote the formation of mineralized tissue
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Egyptian MTA | Experimental | Drug: Egyptian MTA* Complete caries removal from the cavity. * The liquid of Egyptian MTA (Toothmate) will be mixed with powder according to the manufacturers' instructions. * The capping materials will be placed with the passive application on the deepest part of the cavity. Only light pressure will be applied on the MTA mixture using a wet cotton pellet to ensure adaptation of the material onto the dentin. * A light-cured glass ionomer cement base will be applied in the cavity . * Selective enamel etching will be applied on enamel only. * The one-bottle universal adhesive system bond will be applied on enamel and dentine. * A Nano hybrid composite resin material will then be incrementally inserted into the cavities. |
| Biodentine | Experimental | Drug: Biodentine* Complete caries removal from the cavity. * Gently tapping a capsule of Biodentine (Septodont) on a hard surface to loosen the powder, then opening the capsule, Detaching a single-dose container of liquid and gently tapping on the sealed cap to force all the liquid down the container, Twisting cap to open, Then Pouring 5 drops from the single-dose container into the capsule, Then Closing the capsule and Placing it on a mixing device for 30 seconds, Then Collecting Biodentine with the instrument supplied in the box. * The capping materials will be placed with the passive application on the deepest part of the cavity. * A light-cured glass ionomer cement base will be applied in the cavity . * Selective enamel etching will be applied on enamel only. * The one-bottle universal adhesive system bond will be applied on enamel and dentine. * A Nano hybrid composite resin material will then be incrementally inserted into the cavities. |
| Calcium Hydroxide | Active comparator | Drug: Calcium Hydroxide (Ca(OH)2)* Complete caries removal from the cavity. * According to the manufacturers' instructions, Dispensing equal volumes of base and catalyst pastes on the parchment paper pad provided. Using a Dycal (Dentsply) Liner applicator, stirring immediately to mix thoroughly until a uniform color is achieved, complete mixing occurs within 10 seconds, using the ball-pointed Dycal Liner applicator or similar instrument, the mix will be placed directly on the cavity. * The capping materials will be placed with the passive application on the deepest part of the cavity. * A light-cured glass ionomer cement base will be applied in the cavity . * Selective enamel etching will be applied on enamel only. * The one-bottle universal adhesive system bond will be applied on enamel and dentine. * A Nano hybrid composite resin material will then be incrementally inserted into the cavities. |
Who may qualify
- Ages
- 22 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Adult patients aged 22: 45 years old.
- Males or females.
- Patients with vital teeth with deep carious lesions.
- Patients in good general health.
- Good oral hygiene.
Key exclusion criteria (4 listed)
- Patients with systemic diseases.
- Patients with known allergic or adverse reaction to the tested materials.
- Patients with bad oral hygiene.
- Patient who frequently use analgesic or any drugs that could mask the pain.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Egyptian MTA* Complete caries removal from the cavity. * The liquid of Egyptian MTA (Toothmate) will be mixed with powder according to the manufacturers' instructions. * The capping materials will be placed with the passive application on the deepest part of the cavity. Only light pressure will be applied on the MTA mixture using a wet cotton pellet to ensure adaptation of the material onto the dentin. * A light-cured glass ionomer cement base will be applied in the cavity . * Selective enamel etching will be applied on enamel only. * The one-bottle universal adhesive system bond will be applied on enamel and dentine. * A Nano hybrid composite resin material will then be incrementally inserted into the cavities. | Drug | Egyptian MTA |
| Biodentine* Complete caries removal from the cavity. * Gently tapping a capsule of Biodentine (Septodont) on a hard surface to loosen the powder, then opening the capsule, Detaching a single-dose container of liquid and gently tapping on the sealed cap to force all the liquid down the container, Twisting cap to open, Then Pouring 5 drops from the single-dose container into the capsule, Then Closing the capsule and Placing it on a mixing device for 30 seconds, Then Collecting Biodentine with the instrument supplied in the box. * The capping materials will be placed with the passive application on the deepest part of the cavity. * A light-cured glass ionomer cement base will be applied in the cavity . * Selective enamel etching will be applied on enamel only. * The one-bottle universal adhesive system bond will be applied on enamel and dentine. * A Nano hybrid composite resin material will then be incrementally inserted into the cavities. | Drug | Biodentine |
| Calcium Hydroxide (Ca(OH)2)* Complete caries removal from the cavity. * According to the manufacturers' instructions, Dispensing equal volumes of base and catalyst pastes on the parchment paper pad provided. Using a Dycal (Dentsply) Liner applicator, stirring immediately to mix thoroughly until a uniform color is achieved, complete mixing occurs within 10 seconds, using the ball-pointed Dycal Liner applicator or similar instrument, the mix will be placed directly on the cavity. * The capping materials will be placed with the passive application on the deepest part of the cavity. * A light-cured glass ionomer cement base will be applied in the cavity . * Selective enamel etching will be applied on enamel only. * The one-bottle universal adhesive system bond will be applied on enamel and dentine. * A Nano hybrid composite resin material will then be incrementally inserted into the cavities. | Drug | Calcium Hydroxide |
Primary outcome
Clinical assessment of treatment success
Time frame: T( Time) T0( base line)= one week after , T2= 3 months , T3= 6 months
Pulp response to different stimuli by thermal and electrical pulp tests. When tooth normally responds to thermal and electrical pulp tests = success When tooth doesn't respond to thermal and electrical pulp tests = failure
2 secondary outcomes
Clinical assessment of pain
Time frame: T( time) T0( baseline )= 1 week after, T1= 3 months, T2= 6 months
Patient satisfaction with the treatment
Time frame: T( time) T0= 1 week after, T1= 3 months , T2= 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Egyptian MTA, Biodentine and Calcium Hydroxide (Ca(OH)2) in people with Deep Caries and Indirect Pulp Capping, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alaa T Elsorogy, Master's candidate (0020201010009938, alaa.elsorogy@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical assessment of treatment success (time frame: T( Time) T0( base line)= one week after , T2= 3 months , T3= 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.