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Trial record 8 of 51 for:    tooth decay | NIH

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

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Conditions: Dental Caries
Secondary Dental Caries
Personal Satisfaction
Interventions: Device: Papacarie®
Procedure: Conventional method

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study population consists of students attending primary schools in Khon Kaen province, Thailand. Consented children were obtain clinical and radiographic examination at the Pediatric Department, Faculty of Dentistry, Khon Kaen University (KKU) in order to evaluate for their eligibility. The recruitment period were November 2012 to August 2013.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Among of 1299 children provided the consent and received an oral examination, 518 children received a radiographic examination for definite diagnosis. From 494 eligible children, 488 have been enrolled. The rest were not enrolled either because of parental refusal (n=2), child refusal (n=3), or the child moved to another province (n=1).

Reporting Groups
  Description
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.

Conventional method: caries removal by using rotary instrument.

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.

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


Participant Flow:   Overall Study
    Control Arm   Intervention Arm
STARTED   246   242 
COMPLETED   211   217 
NOT COMPLETED   35   25 
Lost to Follow-up                21                16 
Lost the tooth due to normal exfoliation                14                8 
Died due to drowning                0                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

Conventional method: caries removal by using rotary instrument.

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.

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

Total Total of all reporting groups

Baseline Measures
   Control Arm   Intervention Arm   Total 
Overall Participants Analyzed 
[Units: Participants]
 246   242   488 
Age 
[Units: Months]
Mean (Standard Deviation)
 89.9  (8.4)   89.2  (7.5)   89.5  (8.0) 
Gender 
[Units: Participants]
     
Female   129   116   245 
Male   117   126   243 


  Outcome Measures

1.  Primary:   Number of Participants With Treatment Failure   [ Time Frame: two years ]

2.  Secondary:   Incidence of Secondary Caries   [ Time Frame: two years ]

3.  Secondary:   Number of Participants With Complete Caries Removal   [ Time Frame: immediately after treatment ]

4.  Secondary:   Levels of Pain and Discomfort   [ Time Frame: immediately after treatment ]

5.  Secondary:   Time Use for Caries Removal   [ Time Frame: Immediately while treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The limitations: First, the long duration of the trial caused participants to lost to follow up. Second, the operator and patients could not be blinded from the treatment status because of the apparent difference in the intervention techniques.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Kemporn Kitsahawong
Organization: Khon Kaen University
phone: 66-910-566-996
e-mail: kkempo@kku.ac.th



Responsible Party: Kemporn Kitsahawong, Khon Kaen University
ClinicalTrials.gov Identifier: NCT01641861     History of Changes
Other Study ID Numbers: HE542161
D43TW007768 ( U.S. NIH Grant/Contract )
First Submitted: July 9, 2012
First Posted: July 17, 2012
Results First Submitted: December 6, 2015
Results First Posted: March 3, 2016
Last Update Posted: March 3, 2016