Chemomechanical Caries Removal Using Papain Gel

NCT ID: NCT01811420

Last Updated: 2013-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2011-03-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Dental Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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CHEMOMECHANICAL CARIES REMOVAL

Dental caries removal using papain based gel

Group Type EXPERIMENTAL

Chemomechanical Caries Removal

Intervention Type PROCEDURE

Chemomechanical Caries Removal Using A Papain-Based Gel

conventional method

Dental caries removal using rotatory instrument

Group Type ACTIVE_COMPARATOR

Conventional method

Intervention Type PROCEDURE

Dental caries removal using rotatory instrument

Interventions

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Chemomechanical Caries Removal

Chemomechanical Caries Removal Using A Papain-Based Gel

Intervention Type PROCEDURE

Conventional method

Dental caries removal using rotatory instrument

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

4 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Nove de Julho

OTHER

Sponsor Role lead

Responsible Party

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Lara Jansiski Motta

PhD Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lara J Motta, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Nove de Julho

Locations

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Universidade Nove de Julho

São Paulo, Sao Apaulo, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type DERIVED
PMID: 24838896 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24363672 (View on PubMed)

Other Identifiers

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cariesremoval09

Identifier Type: -

Identifier Source: org_study_id

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