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

Study of Papacarie® for Caries Removal.

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

Study Overview

• Status: Completed
• Conditions: Dental Caries; Personal Satisfaction; Secondary Dental Caries
• Intervention / Treatment: Procedure: Conventional method; Device: Papacarie®

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.

• Study Type: Interventional
• Enrollment (Actual): 488
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Khon Kaen
    • Muang, Khon Kaen, Thailand, 40002
      • Faculty of Dentistry , Khon Kaen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 8 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: Papacarie®; Papacarie® is chemo-mechanical method for caries removal; Other Names: Chemo-mechanical removal of decays Agent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Secondary Caries	The restoration teeth were assess by clinical and radiographic examination for detection the recurrent caries.	two years
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
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
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

Collaborators and Investigators

• Sponsor: Khon Kaen University
• Collaborators: National Institutes of Health (NIH); Fogarty International Center of the National Institute of Health
• Investigators: Principal Investigator: Kemporn Kitsahawong, DDS., MSc., Faculty of Dentistry, Khon Kaen University

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: July 9, 2012
• First Submitted That Met QC Criteria: July 16, 2012
• First Posted (Estimate): July 17, 2012

Study Record Updates

• Last Update Posted (Estimate): March 3, 2016
• Last Update Submitted That Met QC Criteria: February 3, 2016
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Chemo-mechanical caries removal; Papacarie®
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: HE542161; D43TW007768 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No