Clinical and Radiographic Evaluation of MTA Pulpotomy Versus Conventional Pulpectomy in Primary Molars With Irreversible Pulpitis

December 26, 2024 updated by: Zeyad Nasr Abdelhafeiz, Cairo University

Clinical and Radiographic Evaluation of MTA Pulpotomy Versus Conventional Pulpectomy in Primary Molars With Irreversible Pulpitis: A Randomized Clinical Trial

This study is designed to compare between MTA Pulpotomy (Removal of coronal pulp tissue, placing MTA and covering with Stainless steel crown) Versus Conventional Pulpectomy (Removal of radicular pulp tissue, placing Zinc Oxide/Eugenol and covering with Stainless steel crown) in irreversible pulpitis in primary second molars.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

42

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
        • Cairo University

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

Yes

Description

Inclusion Criteria:

  • Patients:
  • Aged 4-7 years, cooperative, in good general health and medically within normal
  • Teeth:
  • Restorable mandibular second primary molars.
  • History of irreversible pulpitis.
  • Preoperative radiograph:
  • Absence of periapical or inter-radicular radiolucency.
  • Absence of widening of periodontal ligaments (PDL) space.
  • Absence of internal or external root resorption.

Exclusion Criteria:

  • Patients:
  • With systemic disorders.
  • Physical or mental disabilities.
  • Unable to attend follow- up visits.
  • Refusal of Participation.
  • Refusal to sign the informed consent.
  • Teeth:
  • Previously accessed teeth.
  • Mobile mandibular second primary molar.
  • Swelling in the vestibule or on palpation.
  • Pain on percussion.

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Conventional Pulpectomy
Conventional pulpectomy using Zinc Oxide/Eugenol
Procedure: Conventional Pulpectomy
Removal of radicular pulp tissue, placing Zinc Oxide/Eugenol and covered by stainless steel crown
Experimental: MTA Pulpotomy
Pulpotomy using MTA
Procedure: MTA Pulpotomy
Removal of coronal pulp tissue, placing MTA and covered by stainless steel crown

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
• rate of clinical success
Time Frame: 12 months
  • tenderness on percussion and palpation
  • sinus/parulis/fistula
  • soft tissue swelling
  • pathological mobility
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
• rate of radiographic success
Time Frame: 12 months
  • pathologic root resorption.
  • interradicular and/or periapical radiolucency
12 months

Collaborators and Investigators

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

Sponsor

Cairo 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 (Estimated)

January 1, 2025

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

December 10, 2024

First Submitted That Met QC Criteria

December 26, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 26, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pulpotomy Versus Pulpectomy

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • CSR

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.

Subscribe