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Trial record 90 of 1214 for:    tooth decay

Chemomechanical Caries Removal Using Papain Gel (CMCR09)

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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

Tracking Information
First Submitted Date  ICMJE March 6, 2013
First Posted Date  ICMJE March 14, 2013
Last Update Posted Date March 14, 2013
Study Start Date  ICMJE March 2009
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 12, 2013)
restauration evaluation [ Time Frame: 18 months ]
the restauration will be assessed by clinical examination for detection the current caries
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 12, 2013)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: March 12, 2013)
radiographic status [ Time Frame: 18 months ]
the restauration will be assessed by radiographic examination for detection the current caries
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Chemomechanical Caries Removal Using Papain Gel
Official Title  ICMJE Chemomechanical Caries Removal Using a Papain-Based Gel: A Randomized Clinical Trial
Brief Summary To evaluate the efficacy of a papain-based gel in caries removal.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Dental Caries
Intervention  ICMJE
  • Procedure: Chemomechanical Caries Removal
    Chemomechanical Caries Removal Using A Papain-Based Gel
  • Procedure: Conventional method
    Dental caries removal using rotatory instrument
Study Arms  ICMJE
  • Experimental: CHEMOMECHANICAL CARIES REMOVAL
    Dental caries removal using papain based gel
    Intervention: Procedure: Chemomechanical Caries Removal
  • Active Comparator: conventional method
    Dental caries removal using rotatory instrument
    Intervention: Procedure: Conventional method
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 12, 2013)
20
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2011
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years to 6 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01811420
Other Study ID Numbers  ICMJE cariesremoval09
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lara Jansiski Motta, University of Nove de Julho
Study Sponsor  ICMJE University of Nove de Julho
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lara J Motta, PhD University of Nove de Julho
PRS Account University of Nove de Julho
Verification Date March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP