A Comparative Study of Papacarie® and the Conventional Method for Dental Caries Treatment
The purpose study are to evaluate the efficacy of Papacarie® for caries removal in comparison to the conventional drilling method.
Secondary Dental Caries
Procedure: Conventional method
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
|Official Title:||Phase 3 Study of Papacarie® for Caries Removal.|
- restoration status [ Time Frame: two years ] [ Designated as safety issue: Yes ]After treatment the dental restoration will be checked up. This includes the condition of the material use to fill the cavity at 6, 12, 18 and 24 months.
- efficacy of caries removal [ Time Frame: immediately after treatment ] [ Designated as safety issue: Yes ]
- patient's satisfaction [ Time Frame: immediately after treatment ] [ Designated as safety issue: Yes ]Once finish the treatment procedure, the participants will be assessed the satisfaction by using visual analog scale.
- incidence of secondary caries [ Time Frame: two years ] [ Designated as safety issue: Yes ]The restoration teeth will be assessed by clinical and radiographic examination for detection the recurrent caries.
|Study Start Date:||August 2012|
|Estimated Study Completion Date:||August 2015|
|Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
Experimental: Control arm
control arm is dental caries removal using the conventional method. Dental caries will be removed using rotary instrument following the usual procedures employed by the dentist.
Procedure: Conventional method
caries removal by using rotary instrument.
Experimental: Intervention arm
Intervention arm is dental caries removal using Papacarie®. The dentist will apply Papacarie® to dental cavity in order to soften the carious dentine. Dental caries will be removed using hand instrument.
Papacarie® is chemo-mechanical method for caries removal
Other Name: Chemo-mechanical removal of decays Agent
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01641861
|Faculty of Dentistry , Khon Kaen University|
|Muang, Khon Kaen, Thailand, 40002|
|Principal Investigator:||Kemporn Kitsahawong, DDS., MSc.||Faculty of Dentistry, Khon Kaen University|