Pulpitis - IrreversibleNCT07340606
The Role of the Pre-operative Condition and Artificial Intelligence-Assisted Diagnosis in Predicting the Success of Full Pulpotomy in Symptomatic Permanent Mature Molars
A study testing Conventional root canal treatment and Full pulpotomy in people with Pulpitis - Irreversible, run by Misr International University at 2 sites in Egypt.
Trial summary
This study aims to evaluate the effect of prognostic factors, such as the severity of pulpal inflammation, carious pulp exposure, and the presence of apical periodontitis, on the success of full pulpotomy in mature permanent molars with irreversible pulpitis. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulpitis - Irreversible
- What is being tested?
- Conventional root canal treatment and Full pulpotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 2 sitesEgypt
- Study dates
- 17 Jan 2026to 1 Sep 2026
- 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 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Mature permanent molars with irreversible pulpitis.
- Presence of bleeding from all canals.
- The tooth is not periodontally compromised.
Who cannot join
- Non-vital teeth.
- Uncontrolled bleeding from any of the canals after ten minutes of application of hemostatic agent.
- Molars with immature roots.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt2 sites, 2 recruiting
- Recruiting
Misr International University (MIU)
Cairo
Ahmed M. Ghobashy, Prof. Dr.
- Recruiting
Misr International University
Cairo
Ahmed M Ghobashy, Prof. Dr., 19648, miu@miuegypt.edu.eg
About this study
Official title: The Role of Wolters Pulpitis Classification, Apical Periodontitis, and Artificial Intelligence-Assisted Diagnosis in Predicting the Success of Full Pulpotomy in Symptomatic Permanent Mature Molars: A Randomized Controlled Trial
This study aims to evaluate the effect of prognostic factors, such as the severity of pulpal inflammation, carious pulp exposure, and the presence of apical periodontitis, on the success of full pulpotomy in mature permanent molars with irreversible pulpitis. It also aims to investigate the role of artificial intelligence-assisted diagnosis in predicting the prognosis of full pulpotomy.
Read the detailed description
- Patients with mature, permanent molars diagnosed with irreversible pulpitis will be enrolled in the study.
- The pre-operative pulpal status will be assessed using the American Association of Endodontists (AAE) classification and Wolters classification.
- Pre-operative digital radiographs will be taken, and radiographic caries depth will be assessed.
- The presence of pre-operative apical periodontitis will be recorded.
- An artificial intelligence software will process the pre-operative X-rays to assess the presence of carious pulp exposure and apical periodontitis.
- The patients will be randomly allocated to receive either full pulpotomy or conventional root canal treatment.
- The cases will be followed up for 1, 3, and 6 months to assess clinical and radiographic success. The accuracy of the AI software will be compared to the clinical findings of pulpal exposure after caries removal.
- Conditions
- Pulpitis - Irreversible
- Being tested
- Conventional root canal treatment, Full pulpotomy
- Keywords
- irreversible pulpitis, full pulpotomy, artificial intelligence, apical periodontitis
- Medical subject headings
- Periapical Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional root canal treatmentProcedure or surgery
The patients will receive conventional root canal treatment, which is the gold standard treatment protocol in cases with irreversible pulpitis.
Full pulpotomyProcedure or surgery
The patients will receive full pulpotomy as follows:
-Under rubber dam isolation, the operator will perform caries removal, complete the access cavity preparation, achieve hemostasis in all canals, and apply the bioceramic material. The operator will seal the cavity with a glass ionomer restoration.
| Study group | Role | What they receive |
|---|---|---|
| Root Canal Treatment | Active comparator | The patients allocated to this arm will receive conventional root canal treatment. They will be followed up for 1, 3, and 6 months to assess clinical and radiographic success. Receives: Procedure: Conventional root canal treatment |
| Full Pulpotomy | Experimental | The patients allocated to this arm will receive full pulpotomy. They will be followed up for 1, 3, and 6 months to assess clinical and radiographic success. Receives: Procedure: Full pulpotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Successful Cases
- It will be measured as a percentage.
- It will be decided according to the clinical and radiographic criteria of success and failure.
Measured: After 1, 3, and 6 months.
Diagnostic Accuracy (Sensitivity and Specificity) of an artificial intelligence software in detecting carious pulp exposure
The artificial intelligence (AI) software will process pre-operative radiographs to predict the presence of carious pulp exposure. The AI findings will be compared to the clinical findings of carious pulp exposure after caries removal. (Clinical findings of carious pulp exposure will be used as the gold standard).
-The outcome will be reported as sensitivity and specificity.
Measured: On the day of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start17 Jan 2026
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Sep 2026 (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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Misr International University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mayand Amer Mohamed Yehia Amer, Misr International University
- Investigators
- Ahmed M Ghobashy, Prof. Dr., Study director, Misr International UniversityMayand A Amer, B.D.S., Principal investigator, Misr International UniversityMarwan S Ibrahim, B.D.S., Principal investigator, Misr International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07340606
- Sponsor's protocol ID
- MIU-IRB-2425-036
- Status last verified
- Jan 2026
- First submitted
- 5 Jan 2026
- Last updated
- 21 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Wolters Pulpitis Classification, Apical Periodontitis, and Artificial Intelligence-Assisted Diagnosis in Predicting the Success of Full Pulpotomy in Symptomatic Permanent Mature Molars: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07340606
- Acronym / sponsor ID
- MIU-IRB-2425-036
- Conditions
- Pulpitis - Irreversible
- Keywords
- irreversible pulpitis, full pulpotomy, artificial intelligence, apical periodontitis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Misr International UniversityUniversity, hospital or other
- Study start
- 17 Jan 2026 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 14 Jan 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.
This study aims to evaluate the effect of prognostic factors, such as the severity of pulpal inflammation, carious pulp exposure, and the presence of apical periodontitis, on the success of full pulpotomy in mature permanent molars with irreversible pulpitis. It also aims to investigate the role of artificial intelligence-assisted diagnosis in predicting the prognosis of full pulpotomy.
Detailed description
- Patients with mature, permanent molars diagnosed with irreversible pulpitis will be enrolled in the study.
- The pre-operative pulpal status will be assessed using the American Association of Endodontists (AAE) classification and Wolters classification.
- Pre-operative digital radiographs will be taken, and radiographic caries depth will be assessed.
- The presence of pre-operative apical periodontitis will be recorded.
- An artificial intelligence software will process the pre-operative X-rays to assess the presence of carious pulp exposure and apical periodontitis.
- The patients will be randomly allocated to receive either full pulpotomy or conventional root canal treatment.
- The cases will be followed up for 1, 3, and 6 months to assess clinical and radiographic success. The accuracy of the AI software will be compared to the clinical findings of pulpal exposure after caries removal.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Root Canal Treatment | Active comparator | Procedure: Conventional root canal treatmentThe patients allocated to this arm will receive conventional root canal treatment. They will be followed up for 1, 3, and 6 months to assess clinical and radiographic success. |
| Full Pulpotomy | Experimental | Procedure: Full pulpotomyThe patients allocated to this arm will receive full pulpotomy. They will be followed up for 1, 3, and 6 months to assess clinical and radiographic success. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Mature permanent molars with irreversible pulpitis.
- Presence of bleeding from all canals.
- The tooth is not periodontally compromised.
Key exclusion criteria (3 listed)
- Non-vital teeth.
- Uncontrolled bleeding from any of the canals after ten minutes of application of hemostatic agent.
- Molars with immature roots.
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 |
|---|---|---|
| Conventional root canal treatmentThe patients will receive conventional root canal treatment, which is the gold standard treatment protocol in cases with irreversible pulpitis. | Procedure or surgery | Root Canal Treatment |
| Full pulpotomyThe patients will receive full pulpotomy as follows: -Under rubber dam isolation, the operator will perform caries removal, complete the access cavity preparation, achieve hemostasis in all canals, and apply the bioceramic material. The operator will seal the cavity with a glass ionomer restoration. | Procedure or surgery | Full Pulpotomy |
Primary outcome
Percentage of Successful Cases
Time frame: After 1, 3, and 6 months.
* It will be measured as a percentage. * It will be decided according to the clinical and radiographic criteria of success and failure.
Diagnostic Accuracy (Sensitivity and Specificity) of an artificial intelligence software in detecting carious pulp exposure
Time frame: On the day of the procedure
The artificial intelligence (AI) software will process pre-operative radiographs to predict the presence of carious pulp exposure. The AI findings will be compared to the clinical findings of carious pulp exposure after caries removal. (Clinical findings of carious pulp exposure will be used as the gold standard). -The outcome will be reported as sensitivity and specificity.
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 21 Jan 2026.
- Individual participant dataSharing planned: Yes
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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.
Ahmed M Ghobashy, Prof. Dr. study director
Misr International University
Mayand A Amer, B.D.S. principal investigator
Misr International University
Marwan S Ibrahim, B.D.S. principal investigator
Misr International University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional root canal treatment and Full pulpotomy in people with Pulpitis - Irreversible, run by Misr International University at 2 sites 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 3 inclusion and 3 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 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Contact Mayand A Amer, B.D.S. (01062509703 ext. +02, mayand.amer@miuegypt.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Successful Cases (time frame: After 1, 3, and 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 21 Jan 2026.