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

• Sponsor: Khon Kaen University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01641861
• Collaborator: National Institutes of Health (NIH) (NIH), Fogarty International Center of the National Institute of Health (NIH)
• Enrollment: 488
• Location: 1
• Arms: 2
• Duration (Months): 37
• Patients Per Site Per Month: 13.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Dental Caries; Secondary Dental Caries; Personal Satisfaction	Device: Papacarie®; Procedure: Conventional method	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 488 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Study of Papacarie® for Caries Removal.
• Study Start Date: Aug 1, 2012
• Actual Primary Completion Date: Sep 1, 2015
• Actual Study Completion Date: Sep 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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 Names: Chemo-mechanical removal of decays Agent

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Treatment Failure [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).

Secondary Outcome Measures

1. Incidence of Secondary Caries [two years]

   The restoration teeth were assess by clinical and radiographic examination for detection the recurrent caries.

2. Number of Participants With Complete Caries Removal [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.

3. Levels of Pain and Discomfort [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.

4. Time Use for Caries Removal [Immediately while treatment]

   The time taken for the removal of carious dentine was recorded using a stopwatch. Recorded time unit is seconds.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 7 Years to 8 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Dentistry , Khon Kaen University	Muang	Khon Kaen	Thailand	40002

Sponsors and Collaborators

• Khon Kaen University
• National Institutes of Health (NIH)
• Fogarty International Center of the National Institute of Health

Investigators

• Principal Investigator: Kemporn Kitsahawong, DDS., MSc., Faculty of Dentistry, Khon Kaen University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kemporn Kitsahawong, Associated Professor, Khon Kaen University
• ClinicalTrials.gov Identifier: NCT01641861
• Other Study ID Numbers: HE542161; D43TW007768
• First Posted: Jul 17, 2012
• Last Update Posted: Mar 3, 2016
• Last Verified: Dec 1, 2015

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Kemporn Kitsahawong, Associated Professor, Khon Kaen University: Chemo-mechanical caries removal; Papacarie®
• Additional relevant MeSH terms: Dental Caries

Study Results

Participant Flow

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 Detail	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
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

Baseline Characteristics

Arm/Group Title	Control Arm	Intervention Arm	Total
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 Participants	246	242	488
Age (months) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [months]	89.9 (8.4)	89.2 (7.5)	89.5 (8.0)
Sex: Female, Male (Count of Participants)
Female	129 52.4%	116 47.9%	245 50.2%
Male	117 47.6%	126 52.1%	243 49.8%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control Arm	Intervention Arm
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
Measure Participants	211	217
Number [participants]	2 0.8%	2 0.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control Arm, Intervention Arm
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1
	Confidence Interval	(2-Sided) 95%; 0.1 to 7.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control Arm	Intervention Arm
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
Measure Participants	211	217
Number [participants]	3 1.2%	10 4.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control Arm, Intervention Arm
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	3.5
	Confidence Interval	(2-Sided) 95%; 0.9 to 12.8
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control Arm	Intervention Arm
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
Measure Participants	246	242
Number [participants]	246 100%	242 100%

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control Arm	Intervention Arm
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
Measure Participants	246	242
Median (Inter-Quartile Range) [Pain score from 0-100]	25	10

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control Arm, Intervention Arm
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.001
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control Arm	Intervention Arm
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
Measure Participants	246	242
Median (Inter-Quartile Range) [seconds]	103	512

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control Arm, Intervention Arm
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.001
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Adverse Events

Time Frame	Adverse event data were collected at follow up visit every six months until two years.
Arm/Group Title	Control Arm		Intervention Arm
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Control Arm		Intervention Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/246 (0%)		0/242 (0%)
Other (Not Including Serious) Adverse Events
	Control Arm		Intervention Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/246 (0%)		0/242 (0%)

Limitations/Caveats

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.