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Trial record 90 of 1201 for:    tooth decay

Chemomechanical Caries Removal Using Papain Gel (CMCR09)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01811420
Recruitment Status : Completed
First Posted : March 14, 2013
Last Update Posted : March 14, 2013
Sponsor:
Information provided by (Responsible Party):
Lara Jansiski Motta, University of Nove de Julho

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

Condition or disease Intervention/treatment Phase
Dental Caries Procedure: Chemomechanical Caries Removal Procedure: Conventional method Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Chemomechanical Caries Removal Using a Papain-Based Gel: A Randomized Clinical Trial
Study Start Date : March 2009
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tooth Decay

Arm Intervention/treatment
Experimental: CHEMOMECHANICAL CARIES REMOVAL
Dental caries removal using papain based gel
Procedure: Chemomechanical Caries Removal
Chemomechanical Caries Removal Using A Papain-Based Gel

Active Comparator: conventional method
Dental caries removal using rotatory instrument
Procedure: Conventional method
Dental caries removal using rotatory instrument




Primary Outcome Measures :
  1. restauration evaluation [ Time Frame: 18 months ]
    the restauration will be assessed by clinical examination for detection the current caries


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. radiographic status [ Time Frame: 18 months ]
    the restauration will be assessed by radiographic examination for detection the current caries



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Ages Eligible for Study:   4 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01811420


Locations
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Brazil
Universidade Nove de Julho
Sao Paulo, Sao Apaulo, Brazil, 01156-080
Sponsors and Collaborators
University of Nove de Julho
Investigators
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Principal Investigator: Lara J Motta, PhD University of Nove de Julho

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Lara Jansiski Motta, PhD Professor, University of Nove de Julho
ClinicalTrials.gov Identifier: NCT01811420     History of Changes
Other Study ID Numbers: cariesremoval09
First Posted: March 14, 2013    Key Record Dates
Last Update Posted: March 14, 2013
Last Verified: March 2013

Keywords provided by Lara Jansiski Motta, University of Nove de Julho:
dental caries
caries removal
chemomechanical caries removal

Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases