Clinical and Radiographic Outcomes of Pulpotomy Versus Pulpectomy in Primary Molars With Symptomatic Irreversible Pulpitis

August 19, 2026 updated by: Osama Seif El-Nasr Hussein Gad El-Hak, Minia University

Clinical and Radiographic Outcomes of Pulpotomy Versus Pulpectomy in Primary Molars With Symptomatic Irreversible Pulpitis: a Parallel Randomized Clinical Trial

The goal of this clinical trial is to learn if MTA pulpotomy compared to pulpectomy have the same clinical and radiographic success in treatment of primary molars diagnosed with symptomatic irreversible pulpitis.

The main questions it aims to answer are:

Does MTA pulpotomy compared to pulpectomy have the same clinical and radiographic success in treatment of primary molars diagnosed with symptomatic irreversible pulpitis?

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The current Randomized clinical Trial will be conducted on 4-6 year old children to evaluate if MTA pulpotomy compared to pulpectomy have the same clinical and radiographic success in treatment of primary molars diagnosed with symptomatic irreversible pulpitis,

Study Type

Interventional

Enrollment (Estimated)

110

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
      • Minya, Egypt
        • Minia University Dental Hospita

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

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • healthy and cooperative children
  • primary mandibular second molars with deep carious lesions and vital pulp
  • restorable crowns
  • history of spontaneous persistent lingering pain
  • normal radiographic appearance

Exclusion Criteria:

  • clinical signs and symptoms of pulp necrosis
  • radiographic evidence of pathological root resorption

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pulpotomy group
Biological: MTA pulp dressing material
The patients with symptomatic irreversible pulpitis in their primary molars was treated by MTA pulpotomy
Active Comparator: Pulpectomy group
Biological: Metapex
The patients with symptomatic irreversible pulpitis in their primary molars was treated by Metapex pulpectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
proportion of treated teeth demonstrating clinical and functional success during follow up intervals
Time Frame: at 3-month postoperatively, at 6-month postoperatively, at 12-month postoperatively, at 18-month postoperatively
score 0 was applied for non functional teeth and score 1 was applied for functional teeth
at 3-month postoperatively, at 6-month postoperatively, at 12-month postoperatively, at 18-month postoperatively

Collaborators and Investigators

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

Sponsor

Minia 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)

July 15, 2025

Primary Completion (Estimated)

January 15, 2027

Study Completion (Estimated)

January 15, 2027

Study Registration Dates

First Submitted

August 16, 2026

First Submitted That Met QC Criteria

August 19, 2026

First Posted (Actual)

August 24, 2026

Study Record Updates

Last Update Posted (Actual)

August 24, 2026

Last Update Submitted That Met QC Criteria

August 19, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1246-2025

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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