Overview

This trial is active, not recruiting.

Conditions dental caries, secondary dental caries, personal satisfaction
Treatments papacarie®, conventional method
Phase phase 3
Sponsor Khon Kaen University
Collaborator National Institutes of Health (NIH)
Start date August 2012
End date August 2013
Trial size 488 participants
Trial identifier NCT01641861, D43TW007768, HE542161

Summary

The purpose study are to evaluate the efficacy of Papacarie® for caries removal in comparison to the conventional drilling method.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (investigator)
Primary purpose treatment
Arm
(Experimental)
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.
conventional method
caries removal by using rotary instrument.
(Experimental)
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® Chemo-mechanical removal of decays Agent
Papacarie® is chemo-mechanical method for caries removal

Primary Outcomes

Measure
restoration status
time frame: two years

Secondary Outcomes

Measure
efficacy of caries removal
time frame: immediately after treatment
patient's satisfaction
time frame: immediately after treatment
incidence of secondary caries
time frame: two years

Eligibility Criteria

Male or female participants from 7 years up to 8 years old.

Inclusion Criteria: - Patient inclusion criteria: - Child is between 7-8 years of ages (at date of enrollment) with at least one active caries lesion in second primary molar tooth with distinct dentine involvement requiring restoration - Child is in good general health and has no existing health condition that may interfere with treatment such as asthma, tuberculosis, rheumatic fever/ congenital heart diseases, jaundice, juvenile diabetes, haemophilia, thalassemia, leukemia, anemia , HIV , allergy to any drug, and epilepsy. - Tooth inclusion criteria: - Second primary molar tooth with one active caries lesion with distinct dentine involvement requiring restoration using the World Health Organization Criteria. - Tooth with isolated occlusal caries and caries extended on further than two-third of the dentine layer, which can be restoration as a Class I restoration. - Carious cavity must be large enough so that the hand instruments can be operated. - Tooth is vital without pathological process assessed clinically and radiographically. Exclusion Criteria: - Patient exclusion criteria: - Child whose parent does not give informed consent. - Child who are unwilling to undergo the dental treatment. - Child who has a known allergy to the ingredients contained in dental anesthesia, Papacarie® or glass-ionomer filling material. - Tooth exclusion criteria: - Having extensive dental caries which may require pulp treatment. - Tooth with a pathological process of the dental tissue other than caries that could affect the treatment, such as tooth development disorders or adjacent soft tissue lesion.

Additional Information

Official title Phase 3 Study of Papacarie® for Caries Removal.
Principal investigator Kemporn Kitsahawong, DDS., MSc.
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by Khon Kaen University.