A Comparative Study of Papacarie® and the Conventional Method for Dental Caries Treatment
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|ClinicalTrials.gov Identifier: NCT01641861|
Recruitment Status : Completed
First Posted : July 17, 2012
Results First Posted : March 3, 2016
Last Update Posted : March 3, 2016
|Condition or disease||Intervention/treatment||Phase|
|Dental Caries Secondary Dental Caries Personal Satisfaction||Device: Papacarie® Procedure: Conventional method||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||488 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Study of Papacarie® for Caries Removal.|
|Study Start Date :||August 2012|
|Actual Primary Completion Date :||September 2015|
|Actual Study Completion Date :||September 2015|
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
- Number of Participants With Treatment Failure [ Time Frame: two years ]The dental restorations were evaluated at 6, 12, 18 and 24 months after treatment. Evaluation criteria included the condition of the filling material and presence of secondary caries at the margin of the restorations. The restoration status was re-categorized as a binary outcome: Treatment failure (Yes/No).
- Incidence of Secondary Caries [ Time Frame: two years ]The restoration teeth were assess by clinical and radiographic examination for detection the recurrent caries.
- Number of Participants With Complete Caries Removal [ Time Frame: immediately after treatment ]The efficacy of caries removal was evaluated by the visual and tactile criteria. The completeness of caries removal was judged on the basis of clinical criteria involving the inspection of the tooth surfaces using a good light source, dental mirror and explorer. A blunt explorer was used to detect surface roughness by gently stroking across the dentine surfaces and to evaluate the dentine hardness. Complete caries removal was achieved if as remove soft and infected dentine until felt hard and leathery consistency of the dentine surfaces. The tactile criteria include the smooth passage of the blunt explorer and absence of a catch or a "tug-back" sensation.
- Levels of Pain and Discomfort [ Time Frame: immediately after treatment ]The participants were assessed for the levels of pain and discomfort using the facial visual analogue scale (VAS). The score was recorded in ruler scale from 0-100 millimeters, 0 = no pain and 100 = extreme pain) before treatment with the child sitting on the dental chair and after treatment (completion of carious tissue removal). The difference in the VAS scores before and after treatment was calculated and compared between the two comparison groups.
- Time Use for Caries Removal [ Time Frame: Immediately while treatment ]The time taken for the removal of carious dentine was recorded using a stopwatch. Recorded time unit is seconds.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01641861
|Faculty of Dentistry , Khon Kaen University|
|Muang, Khon Kaen, Thailand, 40002|
|Principal Investigator:||Kemporn Kitsahawong, DDS., MSc.||Faculty of Dentistry, Khon Kaen University|