Success Rate Evaluation of Miniature Pulpotomy With MTA in Primary Molars

November 7, 2014 updated by: Hossein Nematollahi, Mashhad University of Medical Sciences
The purpose of this study is to evaluate the clinical and radiographic success rate of Miniature pulpotomy with Mineral Trioxide Aggregate (MTA) in primary molars.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 4

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

  • Iran, Islamic Republic of
    • Khorasan Razavi
      • Mashhad, Khorasan Razavi, Iran, Islamic Republic of, 9185769516
        • Recruiting
        • Mashhad University of Medical Siences
        • Contact:
          • Hossein Nematollahi, associate of professor
        • Contact:
          • Homa Noorollahian, associate of professor

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

4 years to 7 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • healthy people(without any systemic disease)

  • teeth :

    • no clinical or radiographic evidence of pulp degeneration
    • the possibility of proper restoration of the teeth

Exclusion Criteria:

  • teeth :

    • excessive bleeding from the exposure site
    • internal root resorption
    • interradicular and/or periapical bone destruction
    • swelling or sinus tract

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: Mineral Trioxide Aggregate
pulpotomy with MTA
Drug: Mineral Trioxide Aggregate
pulpotomy with MTA
Active Comparator: Formocresol
pulpotomy with FC
Drug: Formocresol
pulpotomy with formocresol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
successful outcome of treatment as indicated by clinical signs defined with observation and check list
Time Frame: up to 12 months
success or failure of treatment defined with observation and check list
up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
successful outcome of treatment as indicated by radiographic signs defined with observation and check list
Time Frame: up to 12 months
success or failure of treatment defined with observation and check list
up to 12 months

Collaborators and Investigators

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

Sponsor

Mashhad University of Medical Sciences

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

February 1, 2014

Primary Completion (Anticipated)

July 1, 2015

Study Registration Dates

First Submitted

April 25, 2014

First Submitted That Met QC Criteria

November 7, 2014

First Posted (Estimate)

November 10, 2014

Study Record Updates

Last Update Posted (Estimate)

November 10, 2014

Last Update Submitted That Met QC Criteria

November 7, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 921762

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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