Clinical trial NCT01641861: A Comparative Study of Papacarie® and the Conventional Method for Dental Caries Treatment
Official title: Study of Papacarie® for Caries Removal.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries
Secondary Dental Caries
Personal Satisfaction
Keywords: Chemo-mechanical caries removal
Papacarie®
Lead sponsor: Khon Kaen University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Fogarty International Center of the National Institute of Health
First posted: 2012-07-17
Enrollment: 488
Sex: ALL
Minimum age (years): 7
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Treatment Failure
timeFrame: two years
Secondary outcomes:
measure: Incidence of Secondary Caries
timeFrame: two years
measure: Number of Participants With Complete Caries Removal
timeFrame: immediately after treatment
measure: Levels of Pain and Discomfort
timeFrame: immediately after treatment
measure: Time Use for Caries Removal
timeFrame: Immediately while treatment
Other outcomes:
Locations:
city: Muang
country: Thailand
facility: Faculty of Dentistry , Khon Kaen University
state: Khon Kaen
Study officials:
affiliation: Faculty of Dentistry, Khon Kaen University
name: Kemporn Kitsahawong, DDS., MSc.
role: PRINCIPAL_INVESTIGATOR
References: