Pulpotomy of Young Permanent MolarsPhase 3NCT07207382
Clinical and Radiographic Evaluation of Three Biomimetic Materials in Pulp Therapy of Immature Young Permanent Teeth "A Randomized Controlled Clinical Trial"
A Phase 3 study testing MTA group, Premixed Bioceramic material and Treated Dentin Matrix in people with Pulpotomy of Young Permanent Molars, run by Ain Shams University at 1 site in Egypt.
Trial summary
Statement of the problem: Pulpotomy is the most popular technique for maintaining vitality and has a substantial impact on continuing root growth in vital, young permanent molars suffering from dental cavities. Read more about this study
- Who is it for?
- Ages 7 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulpotomy of Young Permanent Molars
- What is being tested?
- MTA group, Premixed Bioceramic material and Treated Dentin Matrix
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Feb 2024to 1 Oct 2026
- Phase
- Phase 3
- 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 7 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged between 7 and 10 years-old.
- Vital permanent first molars with deep caries lesion approaches the pulp without symptoms of irreversible pulpitis, with open apices in the radiograph.
- Permanent first molars with pulpal exposure that occurred during caries excavation.
- Incompletely formed roots
Who cannot join
- Teeth with signs and symptoms of chronic infection such as swelling and mobility.
- Teeth with excessive bleeding from amputated radicular stumps
- Teeth showing radiographic evidence of pathologic root resorption, inter-radicular bone loss, periapical pathology and calcifications in the canals.
- Lack of patient/parent compliance and cooperation.
- Children who are physically or mentally disabled or having any medical condition that will complicate the treatment
Trial locations and contacts
1 site in 1 country.
About this study
Statement of the problem:
Pulpotomy is the most popular technique for maintaining vitality and has a substantial impact on continuing root growth in vital, young permanent molars suffering from dental cavities.
Read more
Biomimetic materials placement after performing pulp therapy is one of the important factors to determine healing of the pulp and continue root formation. In this study a novel material "Treated Dentin Matrix" is used in comparison to premixed bioceramic material and "Mineral Trioxide Aggregate" in pulpotomy of immature permanent molars.
The Aim of the study:
Is to assess the clinical and radiographic success of pulpotomized first permanent immature molars treated with three different Biomimetic materials (Treated Dentin Matrix, Premixed Bio-ceramic material and Mineral Trioxide Aggregate)
- Conditions
- Pulpotomy of Young Permanent Molars
- Being tested
- MTA group, Premixed Bioceramic material, Treated Dentin Matrix
- Keywords
- young permanent, MTA, Pulpotomy, premixed bioceramic, treated dentin matrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MTA groupDrug
MTA group is considered the control group
Premixed Bioceramic materialDrug
Premixed Bioceramic material is test group B
Treated Dentin MatrixDrug
Treated Dentin Matrix is test group C
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Not described Receives: Drug: MTA group |
| B | Experimental | Not described Receives: Drug: Premixed Bioceramic material |
| C | Experimental | Not described Receives: Drug: Treated Dentin Matrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical success
- Absence of pain related to the treated teeth, Including patient reported pain or sensitivity to percussion/palpation.
- No evidence of swelling of supporting soft tissue or presence of sinus tract.
- Absence of excessive mobility affecting treated teeth.
Measured: 18 months
Radiographic success
- Radiographic criteria for success in terms of:
- Progression of root formation
- No Internal or external root resorption.
- No Periapical or furcal radiolucency.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2025
- Study start20 Feb 2024
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulpotomy of Young Permanent MolarsStudies of the same condition, open and under way.
- More trials run by Ain Shams 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Mohamed Fakhry, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07207382
- Sponsor's protocol ID
- PED23-5D
- Status last verified
- Apr 2026
- First submitted
- 2 Oct 2025
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Three Biomimetic Materials in Pulp Therapy of Immature Young Permanent Teeth "A Randomized Controlled Clinical Trial"
- ClinicalTrials.gov ID
- NCT07207382
- Acronym / sponsor ID
- PED23-5D
- Conditions
- Pulpotomy of Young Permanent Molars
- Keywords
- young permanent, MTA, Pulpotomy, premixed bioceramic, treated dentin matrix
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 20 Feb 2024 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 6 Oct 2025 (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.
Statement of the problem:
Pulpotomy is the most popular technique for maintaining vitality and has a substantial impact on continuing root growth in vital, young permanent molars suffering from dental cavities.
Biomimetic materials placement after performing pulp therapy is one of the important factors to determine healing of the pulp and continue root formation. In this study a novel material "Treated Dentin Matrix" is used in comparison to premixed bioceramic material and "Mineral Trioxide Aggregate" in pulpotomy of immature permanent molars.
The Aim of the study:
Is to assess the clinical and radiographic success of pulpotomized first permanent immature molars treated with three different Biomimetic materials (Treated Dentin Matrix, Premixed Bio-ceramic material and Mineral Trioxide Aggregate)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: MTA group |
| B | Experimental | Drug: Premixed Bioceramic material |
| C | Experimental | Drug: Treated Dentin Matrix |
Who may qualify
- Ages
- 7 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children aged between 7 and 10 years-old.
- Vital permanent first molars with deep caries lesion approaches the pulp without symptoms of irreversible pulpitis, with open apices in the radiograph.
- Permanent first molars with pulpal exposure that occurred during caries excavation.
- Incompletely formed roots
Key exclusion criteria (5 listed)
- Teeth with signs and symptoms of chronic infection such as swelling and mobility.
- Teeth with excessive bleeding from amputated radicular stumps
- Teeth showing radiographic evidence of pathologic root resorption, inter-radicular bone loss, periapical pathology and calcifications in the canals.
- Lack of patient/parent compliance and cooperation.
- Children who are physically or mentally disabled or having any medical condition that will complicate the treatment
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 |
|---|---|---|
| MTA groupMTA group is considered the control group | Drug | A |
| Premixed Bioceramic materialPremixed Bioceramic material is test group B | Drug | B |
| Treated Dentin MatrixTreated Dentin Matrix is test group C | Drug | C |
Primary outcome
Clinical success
Time frame: 18 months
* Absence of pain related to the treated teeth, Including patient reported pain or sensitivity to percussion/palpation. * No evidence of swelling of supporting soft tissue or presence of sinus tract. * Absence of excessive mobility affecting treated teeth.
Radiographic success
Time frame: 18 months
* Radiographic criteria for success in terms of: * Progression of root formation * No Internal or external root resorption. * No Periapical or furcal radiolucency.
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 13 Apr 2026.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MTA group, Premixed Bioceramic material and Treated Dentin Matrix in people with Pulpotomy of Young Permanent Molars, run by Ain Shams 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 4 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 13 Apr 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical success (time frame: 18 months). The study lists 2 primary outcomes in all. 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 13 Apr 2026.