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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
Enrollment 488

Recruitment Details 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 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).
Arm/Group Title Control Arm Intervention Arm
Hide Arm/Group Description

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 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

Period Title: Overall Study
Started 246 242
Completed 211 217
Not Completed 35 25
Reason Not Completed
Lost to Follow-up             21             16
Lost the tooth due to normal exfoliation             14             8
Died due to drowning             0             1
Arm/Group Title Control Arm Intervention Arm Total
Hide Arm/Group Description

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 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 of all reporting groups
Overall Number of Baseline Participants 246 242 488
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 246 participants 242 participants 488 participants
89.9  (8.4) 89.2  (7.5) 89.5  (8.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 246 participants 242 participants 488 participants
Female
129
  52.4%
116
  47.9%
245
  50.2%
Male
117
  47.6%
126
  52.1%
243
  49.8%
1.Primary Outcome
Title Number of Participants With Treatment Failure
Hide Description 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).
Time Frame two years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Arm Intervention Arm
Hide Arm/Group Description:

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 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

Overall Number of Participants Analyzed 211 217
Measure Type: Number
Unit of Measure: participants
2 2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control Arm, Intervention Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1
Confidence Interval (2-Sided) 95%
0.1 to 7.3
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Incidence of Secondary Caries
Hide Description The restoration teeth were assess by clinical and radiographic examination for detection the recurrent caries.
Time Frame two years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Arm Intervention Arm
Hide Arm/Group Description:

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 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

Overall Number of Participants Analyzed 211 217
Measure Type: Number
Unit of Measure: participants
3 10
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control Arm, Intervention Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.5
Confidence Interval (2-Sided) 95%
0.9 to 12.8
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Number of Participants With Complete Caries Removal
Hide Description 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.
Time Frame immediately after treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Arm Intervention Arm
Hide Arm/Group Description:

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 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

Overall Number of Participants Analyzed 246 242
Measure Type: Number
Unit of Measure: participants
246 242
4.Secondary Outcome
Title Levels of Pain and Discomfort
Hide Description 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 Frame immediately after treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Arm Intervention Arm
Hide Arm/Group Description:

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 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

Overall Number of Participants Analyzed 246 242
Median (Inter-Quartile Range)
Unit of Measure: Pain score from 0-100
25
(17 to 37)
10
(0 to 18)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control Arm, Intervention Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
5.Secondary Outcome
Title Time Use for Caries Removal
Hide Description The time taken for the removal of carious dentine was recorded using a stopwatch. Recorded time unit is seconds.
Time Frame Immediately while treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Arm Intervention Arm
Hide Arm/Group Description:

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 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

Overall Number of Participants Analyzed 246 242
Median (Inter-Quartile Range)
Unit of Measure: seconds
103
(92 to 152)
512
(404 to 637)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control Arm, Intervention Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame Adverse event data were collected at follow up visit every six months until two years.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Control Arm Intervention Arm
Hide Arm/Group Description

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 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

All-Cause Mortality
Control Arm Intervention Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Control Arm Intervention Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   0/246 (0.00%)   0/242 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Control Arm Intervention Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   0/246 (0.00%)   0/242 (0.00%) 
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.
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
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