Trials / Completed
CompletedNCT01641861
A Comparative Study of Papacarie® and the Conventional Method for Dental Caries Treatment
Study of Papacarie® for Caries Removal.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 488 (actual)
- Sponsor
- Khon Kaen University · Academic / Other
- Sex
- All
- Age
- 7 Years – 8 Years
- Healthy volunteers
- Accepted
Summary
The purpose study are to evaluate the efficacy of Papacarie® for caries removal in comparison to the conventional drilling method.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Papacarie® | Papacarie® is chemo-mechanical method for caries removal |
| PROCEDURE | Conventional method | caries removal by using rotary instrument. |
Timeline
- Start date
- 2012-08-01
- Primary completion
- 2015-09-01
- Completion
- 2015-09-01
- First posted
- 2012-07-17
- Last updated
- 2016-03-03
- Results posted
- 2016-03-03
Locations
1 site across 1 country: Thailand
Source: ClinicalTrials.gov record NCT01641861. Inclusion in this directory is not an endorsement.