- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01811420
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
Status
Completed
Conditions
Intervention / Treatment
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.
Sponsor
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.
General Publications
- 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.
- 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.
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
Additional Relevant MeSH Terms
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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