Irreversible PulpitisNCT07783217
Clinical and Radiographic Outcomes of Pulpotomy Versus Pulpectomy in Primary Molars With Symptomatic Irreversible Pulpitis
A study testing MTA pulp dressing material and Metapex in people with Irreversible Pulpitis, run by Minia University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to learn if MTA pulpotomy compared to pulpectomy have the same clinical and radiographic success in treatment of primary molars diagnosed with symptomatic irreversible pulpitis. Read more about this study
- Who is it for?
- Ages 4 to 8 years
- Conditions the study is for
- Irreversible Pulpitis
- What is being tested?
- MTA pulp dressing material and Metapex
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jul 2025to 15 Jan 2027
- 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 4 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- healthy and cooperative children
- primary mandibular second molars with deep carious lesions and vital pulp
- restorable crowns
- history of spontaneous persistent lingering pain
- normal radiographic appearance
Who cannot join
- clinical signs and symptoms of pulp necrosis
- radiographic evidence of pathological root resorption
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Radiographic Outcomes of Pulpotomy Versus Pulpectomy in Primary Molars With Symptomatic Irreversible Pulpitis: a Parallel Randomized Clinical Trial
The goal of this clinical trial is to learn if MTA pulpotomy compared to pulpectomy have the same clinical and radiographic success in treatment of primary molars diagnosed with symptomatic irreversible pulpitis.
The main questions it aims to answer are:
Does MTA pulpotomy compared to pulpectomy have the same clinical and radiographic success in treatment of primary molars diagnosed with symptomatic irreversible pulpitis?
Read the detailed description
The current Randomized clinical Trial will be conducted on 4-6 year old children to evaluate if MTA pulpotomy compared to pulpectomy have the same clinical and radiographic success in treatment of primary molars diagnosed with symptomatic irreversible pulpitis,
- Conditions
- Irreversible Pulpitis
- Being tested
- MTA pulp dressing material, Metapex
- Keywords
- MTA Pulpotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MTA pulp dressing materialBiological
The patients with symptomatic irreversible pulpitis in their primary molars was treated by MTA pulpotomy
MetapexBiological
The patients with symptomatic irreversible pulpitis in their primary molars was treated by Metapex pulpectomy
| Study group | Role | What they receive |
|---|---|---|
| Pulpotomy group | Experimental | Not described Receives: Biological: MTA pulp dressing material |
| Pulpectomy group | Active comparator | Not described Receives: Biological: Metapex |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of treated teeth demonstrating clinical and functional success during follow up intervals
score 0 was applied for non functional teeth and score 1 was applied for functional teeth
Measured: at 3-month postoperatively, at 6-month postoperatively, at 12-month postoperatively, at 18-month postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start15 Jul 2025
- Primary completion15 Jan 2027 (estimated)
- Study completion15 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irreversible PulpitisStudies of the same condition, open and under way.
- More trials run by Minia 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Osama Seif El-Nasr Hussein Gad El-Hak, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07783217
- Sponsor's protocol ID
- 1246-2025
- Status last verified
- Aug 2026
- First submitted
- 16 Aug 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Outcomes of Pulpotomy Versus Pulpectomy in Primary Molars With Symptomatic Irreversible Pulpitis: a Parallel Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07783217
- Acronym / sponsor ID
- 1246-2025
- Conditions
- Irreversible Pulpitis
- Keywords
- MTA Pulpotomy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 15 Jul 2025 (actual)
- Primary completion
- 15 Jan 2027 (estimated)
- Study completion
- 15 Jan 2027 (estimated)
- First posted
- 24 Aug 2026 (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 goal of this clinical trial is to learn if MTA pulpotomy compared to pulpectomy have the same clinical and radiographic success in treatment of primary molars diagnosed with symptomatic irreversible pulpitis.
The main questions it aims to answer are:
Does MTA pulpotomy compared to pulpectomy have the same clinical and radiographic success in treatment of primary molars diagnosed with symptomatic irreversible pulpitis?
Detailed description
The current Randomized clinical Trial will be conducted on 4-6 year old children to evaluate if MTA pulpotomy compared to pulpectomy have the same clinical and radiographic success in treatment of primary molars diagnosed with symptomatic irreversible pulpitis,
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulpotomy group | Experimental | Biological: MTA pulp dressing material |
| Pulpectomy group | Active comparator | Biological: Metapex |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- healthy and cooperative children
- primary mandibular second molars with deep carious lesions and vital pulp
- restorable crowns
- history of spontaneous persistent lingering pain
- normal radiographic appearance
Key exclusion criteria (2 listed)
- clinical signs and symptoms of pulp necrosis
- radiographic evidence of pathological root resorption
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 pulp dressing materialThe patients with symptomatic irreversible pulpitis in their primary molars was treated by MTA pulpotomy | Biological | Pulpotomy group |
| MetapexThe patients with symptomatic irreversible pulpitis in their primary molars was treated by Metapex pulpectomy | Biological | Pulpectomy group |
Primary outcome
proportion of treated teeth demonstrating clinical and functional success during follow up intervals
Time frame: at 3-month postoperatively, at 6-month postoperatively, at 12-month postoperatively, at 18-month postoperatively
score 0 was applied for non functional teeth and score 1 was applied for functional teeth
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 Aug 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. 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 study testing MTA pulp dressing material and Metapex in people with Irreversible Pulpitis, run by Minia 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 5 inclusion and 2 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 24 Aug 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.
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?
proportion of treated teeth demonstrating clinical and functional success during follow up intervals (time frame: at 3-month postoperatively, at 6-month postoperatively, at 12-month postoperatively, at 18-month postoperatively). 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 Aug 2026.