Back to resultsA Comparative Study of Papacarie® and the Conventional Method for Dental Caries Treatment
Primary Purpose
Dental Caries, Secondary Dental Caries, Personal Satisfaction
Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Papacarie®
Conventional method
Sponsored by
About this trial
This is an interventional treatment trial for Dental Caries focused on measuring Chemo-mechanical caries removal, Papacarie®
Eligibility 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.
Sites / Locations
- Faculty of Dentistry , Khon Kaen University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Control arm
Intervention arm
Arm 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.
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.
Outcomes
Primary Outcome Measures
Number of Participants With Treatment Failure
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
The restoration teeth were assess by clinical and radiographic examination for detection the recurrent caries.
Number of Participants With Complete Caries Removal
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
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
The time taken for the removal of carious dentine was recorded using a stopwatch. Recorded time unit is seconds.
Full Information
NCT ID
NCT01641861
First Posted
July 9, 2012
Last Updated
February 3, 2016
Sponsor
Khon Kaen University
Collaborators
National Institutes of Health (NIH), Fogarty International Center of the National Institute of Health
1. Study Identification
Unique Protocol Identification Number
NCT01641861
Brief Title
A Comparative Study of Papacarie® and the Conventional Method for Dental Caries Treatment
Official Title
Study of Papacarie® for Caries Removal.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Khon Kaen University
Collaborators
National Institutes of Health (NIH), Fogarty International Center of the National Institute of Health
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries, Secondary Dental Caries, Personal Satisfaction
Keywords
Chemo-mechanical caries removal, Papacarie®
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
488 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control arm
Arm Type
Experimental
Arm 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.
Arm Title
Intervention arm
Arm Type
Experimental
Arm Description
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 Type
Device
Intervention Name(s)
Papacarie®
Other Intervention Name(s)
Chemo-mechanical removal of decays Agent
Intervention Description
Papacarie® is chemo-mechanical method for caries removal
Intervention Type
Procedure
Intervention Name(s)
Conventional method
Intervention Description
caries removal by using rotary instrument.
Primary Outcome Measure Information:
Title
Number of Participants With Treatment Failure
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
Secondary Outcome Measure Information:
Title
Incidence of Secondary Caries
Description
The restoration teeth were assess by clinical and radiographic examination for detection the recurrent caries.
Time Frame
two years
Title
Number of Participants With Complete Caries Removal
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
Title
Levels of Pain and Discomfort
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
Title
Time Use for Caries Removal
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kemporn Kitsahawong, DDS., MSc.
Organizational Affiliation
Faculty of Dentistry, Khon Kaen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Dentistry , Khon Kaen University
City
Muang
State/Province
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
12. IPD Sharing Statement
Plan to Share IPD
No
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A Comparative Study of Papacarie® and the Conventional Method for Dental Caries Treatment
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