Using pre-operative findings and AI to predict whether full pulpotomy will succeed in painful mature molars
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
We will test whether pre-surgery clinical signs and an AI read of dental X-rays can predict if full pulpotomy will work for adults with irreversible pulpitis in mature molars.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 58 (estimated) |
| Ages | 20 Years to 45 Years |
| Sex | All |
| Sponsor | Misr International University Academic / other |
| Locations | 2 sites (Cairo and 1 other locations) |
| Trial ID | NCT07340606 on ClinicalTrials.gov |
What this trial studies
Adults with mature permanent molars diagnosed with irreversible pulpitis will be enrolled and their pre-operative pulpal status classified using the AAE and Wolters systems. Digital radiographs will be taken to measure caries depth and to record any apical periodontitis, and an AI tool will analyze the X-rays for carious pulp exposure and apical changes. Participants will be randomly assigned to receive either full pulpotomy or conventional root canal treatment, with clinical and radiographic follow-up at 1, 3, and 6 months. The study will compare treatment outcomes and the AI software’s accuracy against clinical findings after caries removal.
Who should consider this trial
Good fit: Adults who have mature, permanent molars with a diagnosis of irreversible pulpitis, visible bleeding from all canals, and no significant periodontal compromise are ideal candidates.
Not a fit: Patients with non-vital teeth, immature roots, uncontrolled canal bleeding despite hemostatic measures, or those unable to attend in-person follow-ups are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could help dentists choose less invasive full pulpotomy for appropriate cases, preserving more teeth and avoiding unnecessary root canals.
How similar studies have performed: Clinical reports have shown promising outcomes for full pulpotomy in permanent teeth, while applying AI to predict pulpal prognosis from radiographs is relatively new and less established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Mature permanent molars with irreversible pulpitis. * Presence of bleeding from all canals. * The tooth is not periodontally compromised. Exclusion Criteria: * Non-vital teeth. * Uncontrolled bleeding from any of the canals after ten minutes of application of hemostatic agent. * Molars with immature roots.
Where this trial is running
Cairo and 1 other locations
- Misr International University (MIU) — Cairo, Egypt (Recruiting)
- Misr International University — Cairo, Egypt (Recruiting)
Study contacts
- Principal investigator: Mayand A Amer, B.D.S. — Misr International University
- Study coordinator: Mayand A Amer, B.D.S.
- Email: mayand.amer@miuegypt.edu.eg
- Phone: 01062509703
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.