CMCR09: Chemomechanical Caries Removal Using Papain Gel

• Sponsor: University of Nove de Julho (Other)
• Overall Status: Completed
• CT.gov ID: NCT01811420
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Duration (Months): 24
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Dental Caries	Procedure: Chemomechanical Caries Removal; Procedure: Conventional method	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Chemomechanical Caries Removal Using a Papain-Based Gel: A Randomized Clinical Trial
• Study Start Date: Mar 1, 2009
• Actual Primary Completion Date: Mar 1, 2010
• Actual Study Completion Date: Mar 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CHEMOMECHANICAL CARIES REMOVAL Dental caries removal using papain based gel	Procedure: Chemomechanical Caries Removal; Chemomechanical Caries Removal Using A Papain-Based Gel
Active Comparator: conventional method Dental caries removal using rotatory instrument	Procedure: Conventional method; Dental caries removal using rotatory instrument

Outcome Measures

Primary Outcome Measures

1. restauration evaluation [18 months]

   the restauration will be assessed by clinical examination for detection the current caries

Secondary Outcome Measures

1. 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.

Other Outcome Measures

1. radiographic status [18 months]

   the restauration will be assessed by radiographic examination for detection the current caries

Eligibility Criteria

Criteria

• Ages Eligible for Study: 4 Years to 6 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universidade Nove de Julho	Sao Paulo	Sao Apaulo	Brazil	01156-080

Sponsors and Collaborators

• University of Nove de Julho

Investigators

• Principal Investigator: Lara J Motta, PhD, University of Nove de Julho

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lara Jansiski Motta, PhD Professor, University of Nove de Julho
• ClinicalTrials.gov Identifier: NCT01811420
• Other Study ID Numbers: cariesremoval09
• First Posted: Mar 14, 2013
• Last Update Posted: Mar 14, 2013
• Last Verified: Mar 1, 2013

• Keywords provided by Lara Jansiski Motta, PhD Professor, University of Nove de Julho: dental caries; caries removal; chemomechanical caries removal
• Additional relevant MeSH terms: Dental Caries

Study Results

No Results Posted as of Mar 14, 2013