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

NCT06767371 | Completed DMC

• 1 other identifier: MIU-IRB-2324-038
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Full Pulpotomy; Apical Periodontitis; Radiography; X-ray; Periapical Radiolucency; Mature Permanent Molars; Artificial Intelligence; Irreversible Pulpitis; Wolter's Classification; Severe Pulpitis; Moderate Pulpitis; Vital Pulp Therapy

Outcome Measures

Primary Outcomes (1)

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

  Success rate after full pulpotomy in cases with and without apical periodontitis using clinical and radiographic criteria of success and failure

  1,3,6 months

Secondary Outcomes (1)

• Accuracy of AI software in detecting apical periodontitis

  6 months

Study Arms (3)

Teeth with moderate pulpitis without Apical Periodontitis

EXPERIMENTAL

Teeth with moderate pulpitis without 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.

Teeth with severe pulpitis with Apical Periodontitis

EXPERIMENTAL

Teeth with severe pulpitis with Apical Periodontitis to be treated with full pulpotomy

Procedure: Patients with mature permanent molars diagnosed with severe pulpitis with apical periodontitis to be treated with full pulpotomy.

Teeth with irreversible pulpitis

ACTIVE COMPARATOR

Teeth with irreversible pulpitis treated with Conventional root canal treatment.

Procedure: Teeth with irreversible pulpitis

Interventions

Teeth with irreversible pulpitis PROCEDURE

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

Teeth with irreversible pulpitis

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

Teeth with severe pulpitis with Apical Periodontitis

Patients with mature permanent molars diagnosed with moderate pulpitis without 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.

Teeth with moderate pulpitis without Apical Periodontitis

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Misr International University: lead

Study Sites (1)

Misr International University

Cairo, Obour, 23726., Egypt

Location

MeSH Terms

Conditions

Periapical Periodontitis; Pulpitis

Condition Hierarchy (Ancestors)

Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Dental Pulp Diseases; Tooth Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Masters Student

Study Record Dates

• First Submitted: November 3, 2024
• First Posted: January 9, 2025
• Study Start: November 3, 2024
• Primary Completion: August 30, 2025
• Study Completion: August 30, 2025
• Last Updated: February 3, 2026

Record last verified: 2026-01

Locations

EG (1)