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OpenTrials
Completed

NCT Number: NCT01811420

Chemomechanical Caries Removal Using Papain Gel

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

Completed

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Key information

Conditions

Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

4 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidade Nove de Julho

São Paulo, Sao Apaulo, 01156-080, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chemomechanical Caries Removal

Procedure

Chemomechanical Caries Removal Using A Papain-Based Gel

Conventional Method

Procedure

Dental caries removal using rotatory instrument

Primary outcomes

  1. restauration evaluation

    Time frame: 18 months

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

Secondary outcomes

  1. 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.

Other outcomes

  1. radiographic status

    Time frame: 18 months

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

Interested in participating?

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Sponsors and collaborators

Lead sponsor

University of Nove de Julho

Other

Registry information

Official study title

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

Acronym: CMCR09

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Mar 14, 2013
Registry last updated
Mar 14, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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