NCT07340606

The Role of the Pre-operative Condition and Artificial Intelligence-Assisted Diagnosis in Predicting the Success of Full Pulpotomy in Symptomatic Permanent 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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 58 (estimated)
• Sponsor: Misr International University · Academic / Other
• Sex: All
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

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. 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.

Conditions

• Pulpitis - Irreversible

Interventions

Type	Name	Description
PROCEDURE	Conventional root canal treatment	The patients will receive conventional root canal treatment, which is the gold standard treatment protocol in cases with irreversible pulpitis.
PROCEDURE	Full pulpotomy	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.

Timeline

• Start date: 2026-01-17
• Primary completion: 2026-08-01
• Completion: 2026-09-01
• First posted: 2026-01-14
• Last updated: 2026-01-21

Locations

2 sites across 1 country: Egypt