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

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Kemporn Kitsahawong, Khon Kaen University
ClinicalTrials.gov Identifier:
NCT01641861
First received: July 9, 2012
Last updated: September 19, 2013
Last verified: September 2013
  Purpose

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


Condition Intervention Phase
Dental Caries
Secondary Dental Caries
Personal Satisfaction
Device: Papacarie®
Procedure: Conventional method
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Phase 3 Study of Papacarie® for Caries Removal.

Resource links provided by NLM:


Further study details as provided by Khon Kaen University:

Primary Outcome Measures:
  • restoration status [ Time Frame: two years ] [ Designated as safety issue: Yes ]
    After treatment the dental restoration will be checked up. This includes the condition of the material use to fill the cavity at 6, 12, 18 and 24 months.


Secondary Outcome Measures:
  • efficacy of caries removal [ Time Frame: immediately after treatment ] [ Designated as safety issue: Yes ]
  • patient's satisfaction [ Time Frame: immediately after treatment ] [ Designated as safety issue: Yes ]
    Once finish the treatment procedure, the participants will be assessed the satisfaction by using visual analog scale.

  • incidence of secondary caries [ Time Frame: two years ] [ Designated as safety issue: Yes ]
    The restoration teeth will be assessed by clinical and radiographic examination for detection the recurrent caries.


Estimated Enrollment: 488
Study Start Date: August 2012
Estimated Study Completion Date: August 2015
Primary Completion Date: August 2013 (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.

  Eligibility

Ages Eligible for Study:   7 Years to 8 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  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 ClinicalTrials.gov identifier: NCT01641861

Locations
Thailand
Faculty of Dentistry , Khon Kaen University
Muang, Khon Kaen, Thailand, 40002
Sponsors and Collaborators
Khon Kaen University
Investigators
Principal Investigator: Kemporn Kitsahawong, DDS., MSc. Faculty of Dentistry, Khon Kaen University
  More Information

No publications provided

Responsible Party: Kemporn Kitsahawong, Associated Professor, Khon Kaen University
ClinicalTrials.gov Identifier: NCT01641861     History of Changes
Other Study ID Numbers: HE542161, D43TW007768
Study First Received: July 9, 2012
Last Updated: September 19, 2013
Health Authority: Thailand: Khon Kaen University Ethics Committee for Human Research

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

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on July 23, 2014