Comparison of MedCem MTA and Formocresol Used in Pulpotomies in Primary Teeth.

July 1, 2021 updated by: Hadassah Medical Organization

Comparison of MedCem MTA and Formocresol Used in Pulpotomies in Primary Teeth

assess the effect of MedCem MTA as a pulp medicament following pulpotomy in human primary molars with carious pulp exposure in comparison to Formocresol.

Study Overview

Study Type

Interventional

Enrollment (Actual)

60

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

      • Jerusalem, Israel, 91120
        • Hadassah Medical Organization

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 10 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. healthy children
  2. with Asymptomatic primary molars with a deep carious lesion;
  3. Exposure of a vital pulp by caries;
  4. No clinical or radiographic evidence of pulp degeneration, such as excessive bleeding from the root canal, internal root resorption, inter-radicular and/or periapical bone destruction,swelling, or sinus tract;
  5. Ability to perform a leakage free restoration of the teeth using stainless steel crown, or amalgam/resin based restoration.

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: MedCem MTA pulpotomies

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success of MedCem MTA pulpotomy in primary molar
Time Frame: Up to 36 months
No pain, no swelling or sinus tract, no internal root resorption progressing into the bone, no furcation and/or periapical bond destruction.
Up to 36 months

Collaborators and Investigators

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

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

October 1, 2013

Primary Completion (ACTUAL)

June 1, 2021

Study Completion (ACTUAL)

June 1, 2021

Study Registration Dates

First Submitted

September 25, 2013

First Submitted That Met QC Criteria

October 10, 2013

First Posted (ESTIMATE)

October 14, 2013

Study Record Updates

Last Update Posted (ACTUAL)

July 6, 2021

Last Update Submitted That Met QC Criteria

July 1, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • Nathalie- HMO-CTIL

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.

Clinical Trials on Pulpotomies Primary Teeth

Clinical Trials on MedCem MTA pulpotomies in primary teeth.

3
Subscribe