Prospective Comparison of Indirect Pulp Therapy and Mineral Trioxide Aggregate Pulpotomy in Decayed Primary Molars

February 4, 2024 updated by: James R. Boynton, University of Michigan
This prospective study compares the use of indirect pulp therapy and mineral trioxide aggregate pulpotomy for pulp therapy of the primary molar with dental caries approaching the pulp.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

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

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan

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

2 years to 12 years (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Child with at least one primary molar with deep decay approaching the pulp.

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Indirect pulp therapy
Primary molars will be treated with indirect pulp therapy using resin-modified glass ionomer (Vitrebond Plus).
Procedure: Indirect pulp therapy
Decayed dentin is lined with a resin-modified glass ionomer (Vitrebond Plus)
Active Comparator: Pulpotomy
Primary molars treated with MTA pulpotomy.
Procedure: Pulpotomy
A cervical pulpotomy is done and the radicular pulp is lined with Mineral Trioxide Aggregate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical assessment of pulp vitality
Time Frame: 10 years
Pain, mobility, abscess as determined with clinical evaluation
10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiographic assessment of pulp vitality
Time Frame: 10 years
Signs of pulpal degeneration, including evaluation for presence or absence of internal/external root resorption, periodontal ligament widening, and intraradicular radiolucency as determined with radiographic evaluation
10 years

Collaborators and Investigators

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

Sponsor

University of Michigan

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

December 1, 2013

Primary Completion (Actual)

December 1, 2019

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

January 28, 2015

First Submitted That Met QC Criteria

November 30, 2015

First Posted (Estimated)

December 3, 2015

Study Record Updates

Last Update Posted (Estimated)

February 6, 2024

Last Update Submitted That Met QC Criteria

February 4, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 00077025

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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