Success Rate of Full Pulpotomy in Mature Permanent Molars With Irreversible Pulpitis With Apical Periodontitis Detected Using Artificial Intelligence and Those Without Apical Periodontitis: A Randomized Controlled Trial
Trial ID: NCT06767371
Status: COMPLETED
Study type: INTERVENTIONAL
Phase: NA
Start date: 2024-11-03
Completion date: 2025-08-30
Sponsor: Misr International University
Conditions: Irreversible Pulpitis; Apical Periodontitis; Pulpitis
Interventions: Patients with mature permanent molars diagnosed with severe pulpitis with apical periodontitis to be treated with full pulpotomy.; Patients with mature permanent molars diagnosed with moderate pulpitis without apical periodontitis to be treated with full pulpotomy.; Teeth with irreversible pulpitis
Locations: Misr International University
Countries: Egypt
Enrollment: 58
Age range: 20 Years - 45 Years
Sex: ALL

Summary:
Statement of problem: Although performing full pulpotomy in mature permanent molars with irreversible pulpitis showed success rates comparable to RCT, there is a growing need for further studies in order to determine the predictability of pulpotomy in teeth with apical periodontitis. Aim of the study: The aim of this study is to compare the success rates in cases of moderate pulpitis without apical periodontitis in comparison to cases of severe pulpitis with AI-Detected apical periodontitis. Additionally, the study aims to evaluate the accuracy of a novel AI technology in identifying apical periodontitis from radiographs, comparing its findings to the operator\&#39;s radiographical and clinical observations. Subjects and methods: Patients with mature permanent molars diagnosed with irreversible pulpitis will be selected. The teeth will be divided according to the presence or absence of apical periodontitis into 2 groups. The first group being moderate pulpitis without apical periodontitis to be treated with full pulpotomy and the second group being severe pulpitis with apical periodontitis to be treated with full pulpotomy. Finally, a third control group of teeth with irreversible pulpitis to be treated with conventional root canal treatment will be added. An artificial intelligence software will process the preoperative radiographs to detect the presence of apical periodontitis, and its accuracy will be compared to the blinded operator using clinical and radiographic methods. The patients will be randomly allocated to receive either full pulpotomy or conventional root canal treatment. Full pulpotomy using MTA will be performed for groups 1 and 2, and a final restoration will be placed. While group 3 will receive conventional root canal treatment and a final restoration. Cases will be followed up after 1, 3, and 6 months respectively to assess the clinical and radiographic success.

Eligibility criteria:
Inclusion Criteria:

* Presence of vital mature permanent molars diagnosed as severe irreversible pulpitis with apical periodontitis diagnosed clinically and radiographically and cases diagnosed as moderate irreversible pulpitis without apical periodontitis diagnosed clinically and radiographically per Wolter's classification.
* Participants of both genders falling within the age range of 20 to 45 years.
* Confirmation of vital bleeding pulp tissue in all canals following complete pulpotomy.

Exclusion Criteria:

* Non-vital tooth
* Moderate pulpitis with apical periodontitis
* Teeth with Immature roots
* Uncontrolled pulpal bleeding persisting beyond 10 minutes post-application of sodium hypochlorite as a hemostatic agent.
* Insufficient bleeding post-pulp exposure, indicative of pulp degeneration.
* Cases categorized as initial and mild pulpitis per Wolter's classification.

Outcomes:
Success rate after full pulpotomy in cases with and without apical periodontitis