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Success of Pulpotomy in Molars With Pulpitis With Periodontitis Detected Using AI and Those Without Periodontitis

NCT06767371 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2026-02-03

No results posted yet for this study

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\'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.

Conditions

  • Irreversible Pulpitis
  • Apical Periodontitis
  • Pulpitis

Interventions

PROCEDURE

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 severe pulpitis with apical periodontitis to be treated with full pulpotomy.

PROCEDURE

Patients with mature permanent molars diagnosed with moderate pulpitis without 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.

PROCEDURE

Teeth with irreversible pulpitis

Teeth with irreversible pulpitis to be treated with conventional root canal treatment

Sponsors & Collaborators

  • Misr International University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-03
Primary Completion
2025-08-30
Completion
2025-08-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06767371 on ClinicalTrials.gov