A Comparative Study of Papacarie® and the Conventional Method for Dental Caries Treatment

Dental Caries Clinical Trial

Official title:

Study of Papacarie® for Caries Removal.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01641861
• Other study ID #: HE542161
• Secondary ID: D43TW007768
• Status: Completed
• Phase: N/A
• First received: July 9, 2012
• Last updated: February 3, 2016
• Start date: August 2012
• Est. completion date: September 2015

Study information

• Verified date: December 2015
• Source: Khon Kaen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Khon Kaen University Ethics Committee for Human Research
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 488
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 7 Years to 8 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dental Caries
• Personal Satisfaction
• Secondary Dental Caries

Intervention

Device:
• Papacarie®
Papacarie® is chemo-mechanical method for caries removal

Procedure:
• Conventional method
caries removal by using rotary instrument.

Locations

Country	Name	City	State
Thailand	Faculty of Dentistry , Khon Kaen University	Muang	Khon Kaen

Sponsors (3)

Lead Sponsor	Collaborator
Khon Kaen University	John E. Fogarty International Center (FIC), National Institutes of Health (NIH)

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Treatment Failure	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).	two years	Yes
Secondary	Incidence of Secondary Caries	The restoration teeth were assess by clinical and radiographic examination for detection the recurrent caries.	two years	Yes
Secondary	Number of Participants With Complete Caries Removal	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.	immediately after treatment	Yes
Secondary	Levels of Pain and Discomfort	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.	immediately after treatment	Yes
Secondary	Time Use for Caries Removal	The time taken for the removal of carious dentine was recorded using a stopwatch. Recorded time unit is seconds.	Immediately while treatment	Yes