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

This study has been completed.
National Institutes of Health (NIH)
John E. Fogarty International Center (FIC)
Information provided by (Responsible Party):
Kemporn Kitsahawong, Khon Kaen University Identifier:
First received: July 9, 2012
Last updated: February 3, 2016
Last verified: December 2015
The purpose study are to evaluate the efficacy of Papacarie® for caries removal in comparison to the conventional drilling method.

Condition Intervention
Dental Caries
Secondary Dental Caries
Personal Satisfaction
Device: Papacarie®
Procedure: Conventional method

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Study of Papacarie® for Caries Removal.

Resource links provided by NLM:

Further study details as provided by Khon Kaen University:

Primary Outcome Measures:
  • Number of Participants With Treatment Failure [ Time Frame: two years ] [ Designated as safety issue: Yes ]
    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).

Secondary Outcome Measures:
  • Incidence of Secondary Caries [ Time Frame: two years ] [ Designated as safety issue: Yes ]
    The restoration teeth were assess by clinical and radiographic examination for detection the recurrent caries.

  • Number of Participants With Complete Caries Removal [ Time Frame: immediately after treatment ] [ Designated as safety issue: Yes ]
    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.

  • Levels of Pain and Discomfort [ Time Frame: immediately after treatment ] [ Designated as safety issue: Yes ]
    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.

  • Time Use for Caries Removal [ Time Frame: Immediately while treatment ] [ Designated as safety issue: Yes ]
    The time taken for the removal of carious dentine was recorded using a stopwatch. Recorded time unit is seconds.

Enrollment: 488
Study Start Date: August 2012
Study Completion Date: September 2015
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Chemo-mechanical removal of decays Agent

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.


Ages Eligible for Study:   7 Years to 8 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01641861

Faculty of Dentistry , Khon Kaen University
Muang, Khon Kaen, Thailand, 40002
Sponsors and Collaborators
Khon Kaen University
National Institutes of Health (NIH)
John E. Fogarty International Center (FIC)
Principal Investigator: Kemporn Kitsahawong, DDS., MSc. Faculty of Dentistry, Khon Kaen University
  More Information

Responsible Party: Kemporn Kitsahawong, Associated Professor, Khon Kaen University Identifier: NCT01641861     History of Changes
Other Study ID Numbers: HE542161  D43TW007768 
Study First Received: July 9, 2012
Results First Received: December 6, 2015
Last Updated: February 3, 2016
Health Authority: Thailand: Khon Kaen University Ethics Committee for Human Research
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Khon Kaen University:
Chemo-mechanical caries removal

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases processed this record on October 27, 2016