Pulpitis - IrreversibleNCT06913283
Outcome of Pulpotomy With MTA and Biodentin in Permanent Teeth With Caries Exposure
A study testing Pulp Therapy with Mineral trioxide aggregate (MTA) and Pulp Therapy with Biodentine in people with Pulpitis - Irreversible, run by Altamash Institute of Dental Medicine at 1 site in Pakistan.
Trial summary
The success of pulpotomy treatment is affected by the type of biologically active material used.The effects of MTA and biodentine are compared in mature permanent teeth with caries exposure.It is expected that pulpotomy using biodentine will have a high success rate in caries exposed mature teeth compared to mineral… Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Pulpitis - Irreversible
- What is being tested?
- Pulp Therapy with Mineral trioxide aggregate (MTA) and Pulp Therapy with Biodentine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 sitePakistan
- Study dates
- 2 May 2025to Jul 2025
- Phase
- Interventional
- 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 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- mature permanent teeth
Who cannot join
- Teeth with restorations
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Dr. Zahid Iqbal contact
Pakistan1 site
Altamash Institute of Dental Medicine
Karachi, Sindh, 75500
Research Department, +92 3341892931, erc@altamash.pk
About this study
Official title: Outcome of Pulpotomy Using Mineral Trioxide Aggregate and Biodentin in the Mature Permanent Teeth With Carious Exposure
The success of pulpotomy treatment is affected by the type of biologically active material used.The effects of MTA and biodentine are compared in mature permanent teeth with caries exposure.It is expected that pulpotomy using biodentine will have a high success rate in caries exposed mature teeth compared to mineral trioxide aggregate.
- Conditions
- Pulpitis - Irreversible
- Being tested
- Pulp Therapy with Mineral trioxide aggregate (MTA), Pulp Therapy with Biodentine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulp Therapy with Mineral trioxide aggregate (MTA)Procedure or surgery
MTA allowed to set for twenty four hours
Pulp Therapy with BiodentineProcedure or surgery
Biodentine is triturated before use
| Study group | Role | What they receive |
|---|---|---|
| Group A Mineral trioxide aggregate pulpotomy | Active comparator | Not described Receives: Procedure: Pulp Therapy with Mineral trioxide aggregate (MTA) |
| Group B Biodentine pulpotomy | Active comparator | Not described Receives: Procedure: Pulp Therapy with Biodentine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants treated with MTA
Measured: 6 months
Number of Participants treated with Biodentine
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study start2 May 2025 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulpitis - IrreversibleStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Altamash Institute of Dental Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ambreen Mengal, Altamash Institute of Dental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06913283
- Sponsor's protocol ID
- Altamash IDM Ambreen
- Status last verified
- Apr 2025
- First submitted
- 30 Mar 2025
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared because it is mentioned in the patient consent form that details given by the patient and their identity will be kept confidential.
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Pulpotomy Using Mineral Trioxide Aggregate and Biodentin in the Mature Permanent Teeth With Carious Exposure
- ClinicalTrials.gov ID
- NCT06913283
- Acronym / sponsor ID
- Altamash IDM Ambreen
- Conditions
- Pulpitis - Irreversible
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Altamash Institute of Dental MedicineUniversity, hospital or other
- Study start
- 2 May 2025 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 6 Apr 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.
The success of pulpotomy treatment is affected by the type of biologically active material used.The effects of MTA and biodentine are compared in mature permanent teeth with caries exposure.It is expected that pulpotomy using biodentine will have a high success rate in caries exposed mature teeth compared to mineral trioxide aggregate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A Mineral trioxide aggregate pulpotomy | Active comparator | Procedure: Pulp Therapy with Mineral trioxide aggregate (MTA) |
| Group B Biodentine pulpotomy | Active comparator | Procedure: Pulp Therapy with Biodentine |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- mature permanent teeth
Key exclusion criteria (1 listed)
- Teeth with restorations
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 |
|---|---|---|
| Pulp Therapy with Mineral trioxide aggregate (MTA)MTA allowed to set for twenty four hours | Procedure or surgery | Group A Mineral trioxide aggregate pulpotomy |
| Pulp Therapy with BiodentineBiodentine is triturated before use | Procedure or surgery | Group B Biodentine pulpotomy |
Primary outcome
Number of participants treated with MTA
Time frame: 6 months
Number of Participants treated with Biodentine
Time frame: 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 24 Apr 2025.
- Individual participant dataSharing planned: No. IPD will not be shared because it is mentioned in the patient consent form that details given by the patient and their identity will be kept confidential.
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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.
Dr. Zahid Iqbal contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulp Therapy with Mineral trioxide aggregate (MTA) and Pulp Therapy with Biodentine in people with Pulpitis - Irreversible, run by Altamash Institute of Dental Medicine at 1 site in Pakistan.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 24 Apr 2025. 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 Pakistan. 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.
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 Ambreen Mengal (+92 3337860653, ambreenmengal@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants treated with MTA (time frame: 6 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 24 Apr 2025.