Dental Caries Clinical Trial
Official title:
Study of Papacarie® for Caries Removal.
The purpose study are to evaluate the efficacy of Papacarie® for caries removal in comparison to the conventional drilling method.
Dental caries in children continues to affect a significant portion of the world population,
especially in developing countries. There are many techniques used for dental caries
treatment. The conventional method is to remove caries and prepare the cavity using dental
burs. Disadvantages of this method; however, include the patients' repulsion of drilling,
and possible thermal changes on tooth surface that may have an effect on the dental pulp
tissues. In addition, the drilling technique frequently requires local anesthesia injections
and sometimes results in the removal of sound tooth tissues. To overcome these problems and
preserve the healthy dental tissues, the chemo-mechanical caries removal method was
developed. The advantage by chemomechanical caries removal include less traumatic, less need
local anesthesia, reduced chance of dental pulp exposure. And also it could be benefit to
medical compromised patients.
Papacarie® is a new chemo-mechanical technique for caries removal with few published
research and case reports. A randomized controlled trial is therefore needed to determine
the efficacy of its use in general population. The aims of this study are to evaluate the
efficacy of a chemo-mechanical system (Papacarie®) for caries removal in comparison to the
conventional drilling method.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
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