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Trial record 51 of 1216 for:    tooth decay

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

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ClinicalTrials.gov Identifier: NCT01641861
Recruitment Status : Completed
First Posted : July 17, 2012
Results First Posted : March 3, 2016
Last Update Posted : March 3, 2016
Sponsor:
Collaborators:
National Institutes of Health (NIH)
John E. Fogarty International Center (FIC)
Information provided by (Responsible Party):
Kemporn Kitsahawong, Khon Kaen University

Tracking Information
First Submitted Date  ICMJE July 9, 2012
First Posted Date  ICMJE July 17, 2012
Results First Submitted Date  ICMJE December 6, 2015
Results First Posted Date  ICMJE March 3, 2016
Last Update Posted Date March 3, 2016
Study Start Date  ICMJE August 2012
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 3, 2016)
Number of Participants With Treatment Failure [ Time Frame: two years ]
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).
Original Primary Outcome Measures  ICMJE
 (submitted: July 16, 2012)
restoration status [ Time Frame: two years ]
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.
Change History Complete list of historical versions of study NCT01641861 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 3, 2016)
  • Incidence of Secondary Caries [ Time Frame: two years ]
    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 ]
    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 ]
    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 ]
    The time taken for the removal of carious dentine was recorded using a stopwatch. Recorded time unit is seconds.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 16, 2012)
  • efficacy of caries removal [ Time Frame: immediately after treatment ]
  • patient's satisfaction [ Time Frame: immediately after treatment ]
    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 ]
    The restoration teeth will be assessed by clinical and radiographic examination for detection the recurrent caries.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Comparative Study of Papacarie® and the Conventional Method for Dental Caries Treatment
Official Title  ICMJE Study of Papacarie® for Caries Removal.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Dental Caries
  • Secondary Dental Caries
  • Personal Satisfaction
Intervention  ICMJE
  • Device: Papacarie®
    Papacarie® is chemo-mechanical method for caries removal
    Other Name: Chemo-mechanical removal of decays Agent
  • Procedure: Conventional method
    caries removal by using rotary instrument.
Study Arms  ICMJE
  • 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.
    Intervention: Procedure: Conventional method
  • 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.
    Intervention: Device: Papacarie®
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 16, 2012)
488
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2015
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 7 Years to 8 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01641861
Other Study ID Numbers  ICMJE HE542161
D43TW007768 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Kemporn Kitsahawong, Khon Kaen University
Study Sponsor  ICMJE Khon Kaen University
Collaborators  ICMJE
  • National Institutes of Health (NIH)
  • John E. Fogarty International Center (FIC)
Investigators  ICMJE
Principal Investigator: Kemporn Kitsahawong, DDS., MSc. Faculty of Dentistry, Khon Kaen University
PRS Account Khon Kaen University
Verification Date December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP