Chemomechanical Caries Removal Using Papain Gel
CMCR09
1 other identifier
interventional
20
1 country
1
Brief Summary
To evaluate the efficacy of a papain-based gel in caries removal.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2009
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 6, 2013
CompletedFirst Posted
Study publicly available on registry
March 14, 2013
CompletedMarch 14, 2013
March 1, 2013
1 year
March 6, 2013
March 12, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
restauration evaluation
the restauration will be assessed by clinical examination for detection the current caries
18 months
Secondary Outcomes (1)
discomfort or pain
6 months
Other Outcomes (1)
radiographic status
18 months
Study Arms (2)
CHEMOMECHANICAL CARIES REMOVAL
EXPERIMENTALDental caries removal using papain based gel
conventional method
ACTIVE COMPARATORDental caries removal using rotatory instrument
Interventions
Chemomechanical Caries Removal Using A Papain-Based Gel
Eligibility Criteria
You may qualify if:
- Children with active caries without pulpal involvement in two deciduous molar teeth participated in the trial.
- The caries were located on the occlusal surface.
You may not qualify if:
- Children with pathological process of the dental tissue, with pulpal involvement
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universidade Nove de Julho
São Paulo, Sao Apaulo, 01156-080, Brazil
Related Publications (2)
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.
PMID: 24838896DERIVEDMotta 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.
PMID: 24363672DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lara J Motta, PhD
University of Nove de Julho
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD Professor
Study Record Dates
First Submitted
March 6, 2013
First Posted
March 14, 2013
Study Start
March 1, 2009
Primary Completion
March 1, 2010
Study Completion
March 1, 2011
Last Updated
March 14, 2013
Record last verified: 2013-03