Back to resultsChemomechanical Caries Removal Using Papain Gel (CMCR09)
Primary Purpose
Dental Caries
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Chemomechanical Caries Removal
Conventional method
Sponsored by
About this trial
This is an interventional treatment trial for Dental Caries focused on measuring dental caries, caries removal, chemomechanical caries removal
Eligibility 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
Sites / Locations
- Universidade Nove de Julho
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
CHEMOMECHANICAL CARIES REMOVAL
conventional method
Arm Description
Dental caries removal using papain based gel
Dental caries removal using rotatory instrument
Outcomes
Primary Outcome Measures
restauration evaluation
the restauration will be assessed by clinical examination for detection the current caries
Secondary Outcome Measures
discomfort or pain
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.
Full Information
NCT ID
NCT01811420
First Posted
March 6, 2013
Last Updated
March 12, 2013
Sponsor
University of Nove de Julho
1. Study Identification
Unique Protocol Identification Number
NCT01811420
Brief Title
Chemomechanical Caries Removal Using Papain Gel
Acronym
CMCR09
Official Title
Chemomechanical Caries Removal Using a Papain-Based Gel: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nove de Julho
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
Keywords
dental caries, caries removal, chemomechanical caries removal
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CHEMOMECHANICAL CARIES REMOVAL
Arm Type
Experimental
Arm Description
Dental caries removal using papain based gel
Arm Title
conventional method
Arm Type
Active Comparator
Arm Description
Dental caries removal using rotatory instrument
Intervention Type
Procedure
Intervention Name(s)
Chemomechanical Caries Removal
Intervention Description
Chemomechanical Caries Removal Using A Papain-Based Gel
Intervention Type
Procedure
Intervention Name(s)
Conventional method
Intervention Description
Dental caries removal using rotatory instrument
Primary Outcome Measure Information:
Title
restauration evaluation
Description
the restauration will be assessed by clinical examination for detection the current caries
Time Frame
18 months
Secondary Outcome Measure Information:
Title
discomfort or pain
Description
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.
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
radiographic status
Description
the restauration will be assessed by radiographic examination for detection the current caries
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lara J Motta, PhD
Organizational Affiliation
University of Nove de Julho
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidade Nove de Julho
City
Sao Paulo
State/Province
Sao Apaulo
ZIP/Postal Code
01156-080
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
24838896
Citation
Motta LJ, Bussadori SK, Campanelli AP, Silva AL, Alfaya TA, Godoy CH, Navarro MF. Efficacy of Papacarie((R)) in reduction of residual bacteria in deciduous teeth: a randomized, controlled clinical trial. Clinics (Sao Paulo). 2014;69(5):319-22. doi: 10.6061/clinics/2014(05)04.
Results Reference
derived
PubMed Identifier
24363672
Citation
Motta LJ, Bussadori SK, Campanelli AP, da Silva AL, Alfaya TA, de Godoy CH, Navarro MF. Pain during Removal of Carious Lesions in Children: A Randomized Controlled Clinical Trial. Int J Dent. 2013;2013:896381. doi: 10.1155/2013/896381. Epub 2013 Dec 4.
Results Reference
derived
Learn more about this trial
Chemomechanical Caries Removal Using Papain Gel
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