Trial Outcomes & Findings for A Comparative Study of Papacarie® and the Conventional Method for Dental Caries Treatment (NCT NCT01641861)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

488 participants

Primary outcome timeframe

two years

Results posted on

2016-03-03

Participant Flow

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.

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).

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	246	242
Overall Study COMPLETED	211	217
Overall Study NOT COMPLETED	35	25

Reasons for withdrawal

Reasons for withdrawal
Measure	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
Overall Study Lost to Follow-up	21	16
Overall Study Lost the tooth due to normal exfoliation	14	8
Overall Study Died due to drowning	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control Arm n=246 Participants 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 n=242 Participants 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 n=488 Participants Total of all reporting groups
Age, Continuous	89.9 months STANDARD_DEVIATION 8.4 • n=5 Participants	89.2 months STANDARD_DEVIATION 7.5 • n=7 Participants	89.5 months STANDARD_DEVIATION 8.0 • n=5 Participants
Sex: Female, Male Female	129 Participants n=5 Participants	116 Participants n=7 Participants	245 Participants n=5 Participants
Sex: Female, Male Male	117 Participants n=5 Participants	126 Participants n=7 Participants	243 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Control Arm n=211 Participants 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 n=217 Participants 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
Number of Participants With Treatment Failure	2 participants	2 participants

SECONDARY outcome

Timeframe: two years

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

Outcome measures

Outcome measures
Measure	Control Arm n=211 Participants 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 n=217 Participants 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
Incidence of Secondary Caries	3 participants	10 participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Control Arm n=246 Participants 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 n=242 Participants 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
Number of Participants With Complete Caries Removal	246 participants	242 participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Control Arm n=246 Participants 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 n=242 Participants 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
Levels of Pain and Discomfort	25 Pain score from 0-100 Interval 17.0 to 37.0	10 Pain score from 0-100 Interval 0.0 to 18.0

SECONDARY outcome

Timeframe: Immediately while treatment

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

Outcome measures

Outcome measures
Measure	Control Arm n=246 Participants 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 n=242 Participants 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
Time Use for Caries Removal	103 seconds Interval 92.0 to 152.0	512 seconds Interval 404.0 to 637.0

Adverse Events

Control Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Intervention Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Kemporn Kitsahawong

Khon Kaen University

Phone: 66-910-566-996

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place