Chemomechanical Caries Removal Using Papain Gel (CMCR09)

March 12, 2013 updated by: Lara Jansiski Motta, University of Nove de Julho

Chemomechanical Caries Removal Using a Papain-Based Gel: A Randomized Clinical Trial

To evaluate the efficacy of a papain-based gel in caries removal.

Study Overview

Detailed Description

Twenty children with at least two carious molar teeth without pulpal involvement participated in this randomized clinical trial. A total of 40 teeth were randomly divided into two treatment groups: group A, papain-based gel; and group B, conventional technique. Data collection included the time required for caries removal, need for local anesthesia, degree of discomfort, changes in the number of viable bacteria, and clinical evaluation of glass ionomer-cement restorations 6-month post-treatment.

Study Type

Interventional

Enrollment (Actual)

20

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

    • Sao Apaulo
      • Sao Paulo, Sao Apaulo, Brazil, 01156-080
        • Universidade Nove de Julho

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 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children with active caries without pulpal involvement in two deciduous molar teeth participated in the trial.
  • The caries were located on the occlusal surface.

Exclusion Criteria:

  • Children with pathological process of the dental tissue, with pulpal involvement

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: CHEMOMECHANICAL CARIES REMOVAL
Dental caries removal using papain based gel
Chemomechanical Caries Removal Using A Papain-Based Gel
Active Comparator: conventional method
Dental caries removal using rotatory instrument
Dental caries removal using rotatory instrument

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
restauration evaluation
Time Frame: 18 months
the restauration will be assessed by clinical examination for detection the current caries
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
discomfort or pain
Time Frame: 6 months
The Faces Pain Scale was used to evaluate the need for local anesthesia during the procedure. The child was asked to choose a face matching the intensity of his or her pain experience during the procedure.
6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
radiographic status
Time Frame: 18 months
the restauration will be assessed by radiographic examination for detection the current caries
18 months

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Lara J Motta, PhD, University of Nove de Julho

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the 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

March 1, 2009

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

March 6, 2013

First Submitted That Met QC Criteria

March 12, 2013

First Posted (Estimate)

March 14, 2013

Study Record Updates

Last Update Posted (Estimate)

March 14, 2013

Last Update Submitted That Met QC Criteria

March 12, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • cariesremoval09

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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