Chemomechanical Caries Removal Using Papain Gel

Not Applicable

Completed

• Conditions: Dental Caries
• Interventions: Procedure: Chemomechanical Caries Removal; Procedure: Conventional method

• Registration Number: NCT01811420
• Lead Sponsor: University of Nove de Julho

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 Timeline

• Study Start: 2009-03
• Primary Completion: 2010-03
• Study Completion: 2011-03
• Status Verified: 2013-03
• Study First Submitted: 2013-03-06
• Study First Submitted QC: 2013-03-12
• Last Update Submitted: 2013-03-12
• Study First Posted: 2013-03-14
• Last Update Posted: 2013-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CHEMOMECHANICAL CARIES REMOVAL	Chemomechanical Caries Removal	Dental caries removal using papain based gel
conventional method	Conventional method	Dental caries removal using rotatory instrument

Primary Outcome Measures

Name	Time	Method
restauration evaluation	18 months	the restauration will be assessed by clinical examination for detection the current caries

Secondary Outcome Measures

Name	Time	Method
discomfort or pain	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.

Trial Locations

Locations (1)

Universidade Nove de Julho; 🇧🇷 Sao Paulo, Sao Apaulo, Brazil