Evaluation of the Effect of Type 2 Diabetes Mellitus on the Success of Adult Pulpotomy (controlled cli)

December 28, 2025 updated by: Ahmed Mahmoud Mohamed Sulaiman, Al-Azhar University
The aim of the present study will be directed to evaluate the clinical and radiographic success of adult pulpotomies in type 2 diabetic and non-diabetic patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Out of one hundred patients, Seventy Patients were selected from the outpatient clinic at the faculty of dental medicine Al-Azhar University to take part in this study. Diabetic and non diabetic patients aged between 30 and 65 years complaining of irreversible pulpitis related to the lower permanent first or second molar tooth . All patients were clinically reexamined and radiographically assessed using a periapical radiograph.

Study Type

Interventional

Enrollment (Actual)

70

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 Locations

  • Egypt
      • Cairo, Egypt, 11651
        • Moataz A AlKhawas

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
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

lower first or second molar diagnosed with irreversible pulpitis in diabetic and non-diabetic patients

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
Experimental: diabetic
type 2 diabetic patients
Procedure: pulpotomy
complete excision of coronal pulp
Procedure: pulpotomy
excision of coronal pulp
Experimental: non-diabetic
healthy patients
Procedure: pulpotomy
complete excision of coronal pulp
Procedure: pulpotomy
excision of coronal pulp

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Outcome assessment
Time Frame: 3, 6, 12 months

Assessment of outcome was done using the technique described by Zanini et al. Each patient was evaluated at different time intervals;

Treatment was considered successful if there was an intact final restoration, an asymptomatic tooth, and the periapical index score was 1.

Treatment was considered Uncertain if the final restoration is intact, asymptomatic tooth, and the periapical index score of 2.

Treatment was considered a failure if there was not an intact final restoration, irrelevant clinical symptoms and an irrelevant periapical index score.

Treatment was considered a failure if there was an intact final restoration with symptoms and an irrelevant periapical index score.

  • Treatment was considered a failure if there was an intact final restoration, irrelevant clinical symptoms, and the periapical index was 3 or more.
3, 6, 12 months

Collaborators and Investigators

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

Sponsor

Al-Azhar 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 1, 2023

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

December 13, 2025

First Submitted That Met QC Criteria

December 28, 2025

First Posted (Estimated)

January 12, 2026

Study Record Updates

Last Update Posted (Estimated)

January 12, 2026

Last Update Submitted That Met QC Criteria

December 28, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1/6/2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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