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NCT01811420 Clinical Trial

Chemomechanical Caries Removal Using Papain Gel

Dental Caries Clinical Trial

— CMCR09  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01811420
Other study ID # cariesremoval09
Secondary ID
Status Completed
Phase N/A
First received March 6, 2013
Last updated March 12, 2013
Start date March 2009
Est. completion date March 2011

Study information
Verified date March 2013
Source University of Nove de Julho
Contact n/a
Is FDA regulated No
Health authority Brazil: Ethics Committee
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date March 2011
Est. primary completion date March 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 4 Years to 6 Years
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Chemomechanical Caries Removal
Chemomechanical Caries Removal Using A Papain-Based Gel
• Conventional method
Dental caries removal using rotatory instrument

Locations
Country Name City State
Brazil Universidade Nove de Julho Sao Paulo Sao Apaulo

Sponsors (1)
Lead Sponsor Collaborator
University of Nove de Julho

Country where clinical trial is conducted

Brazil, 

Outcome
Type Measure Description Time frame Safety issue
Other radiographic status the restauration will be assessed by radiographic examination for detection the current caries 18 months Yes
Primary restauration evaluation the restauration will be assessed by clinical examination for detection the current caries 18 months Yes
Secondary 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. 6 months Yes
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