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

January 17, 2026 updated by: Mayand Amer Mohamed Yehia Amer, Misr International University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • Misr International University
        • Contact:
      • Cairo, Egypt
        • Recruiting
        • Misr International University (MIU)
        • Contact:
          • Ahmed M. Ghobashy, Prof. Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Root Canal Treatment
The patients allocated to this arm will receive conventional root canal treatment. They will be followed up for 1, 3, and 6 months to assess clinical and radiographic success.
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.
Experimental: Full Pulpotomy
The patients allocated to this arm will receive full pulpotomy. They will be followed up for 1, 3, and 6 months to assess clinical and radiographic success.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Successful Cases
Time Frame: After 1, 3, and 6 months.
  • It will be measured as a percentage.
  • It will be decided according to the clinical and radiographic criteria of success and failure.
After 1, 3, and 6 months.
Diagnostic Accuracy (Sensitivity and Specificity) of an artificial intelligence software in detecting carious pulp exposure
Time Frame: On the day of the procedure

The artificial intelligence (AI) software will process pre-operative radiographs to predict the presence of carious pulp exposure. The AI findings will be compared to the clinical findings of carious pulp exposure after caries removal. (Clinical findings of carious pulp exposure will be used as the gold standard).

-The outcome will be reported as sensitivity and specificity.
On the day of the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Misr International University

Investigators

  • Study Director: Ahmed M Ghobashy, Prof. Dr., Misr International University
  • Principal Investigator: Mayand A Amer, B.D.S., Misr International University
  • Principal Investigator: Marwan S Ibrahim, B.D.S., Misr International University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 17, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

January 5, 2026

First Submitted That Met QC Criteria

January 5, 2026

First Posted (Actual)

January 14, 2026

Study Record Updates

Last Update Posted (Actual)

January 21, 2026

Last Update Submitted That Met QC Criteria

January 17, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MIU-IRB-2425-036

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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