Dental Caries, Secondary Dental Caries, Personal Satisfaction
Conditions
Keywords
Chemo-mechanical caries removal, Papacarie®
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.
Interventions
DEVICEPapacarie®
Papacarie® is chemo-mechanical method for caries removal
PROCEDUREConventional method
caries removal by using rotary instrument.
Sponsors
National Institutes of Health (NIH)
Fogarty International Center of the National Institute of Health
Khon Kaen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
7 Years to 8 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Secondary Caries | two years | The restoration teeth were assess by clinical and radiographic examination for detection the recurrent caries. |
| 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. |
| 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. |
| 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. |
Countries
Thailand
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 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).
Participants by arm
| Arm | Count |
|---|---|
| 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. | 246 |
| 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 | 242 |
| Total | 488 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Died due to drowning | 0 | 1 |
| Overall Study | Lost the tooth due to normal exfoliation | 14 | 8 |
| Overall Study | Lost to Follow-up | 21 | 16 |
Baseline characteristics
| Characteristic | Control Arm | Intervention Arm | Total |
|---|---|---|---|
| Age, Continuous | 89.9 months STANDARD_DEVIATION 8.4 | 89.2 months STANDARD_DEVIATION 7.5 | 89.5 months STANDARD_DEVIATION 8 |
| Sex: Female, Male Female | 129 Participants | 116 Participants | 245 Participants |
| Sex: Female, Male Male | 117 Participants | 126 Participants | 243 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 246 | 0 / 242 |
| serious Total, serious adverse events | 0 / 246 | 0 / 242 |
Outcome results
Primary
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).
Time frame: two years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control Arm | Number of Participants With Treatment Failure | 2 participants |
| Intervention Arm | Number of Participants With Treatment Failure | 2 participants |
95% CI: [0.1, 7.3]
Secondary
Incidence of Secondary Caries
The restoration teeth were assess by clinical and radiographic examination for detection the recurrent caries.
Time frame: two years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control Arm | Incidence of Secondary Caries | 3 participants |
| Intervention Arm | Incidence of Secondary Caries | 10 participants |
95% CI: [0.9, 12.8]
Secondary
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 frame: immediately after treatment
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control Arm | Levels of Pain and Discomfort | 25 Pain score from 0-100 |
| Intervention Arm | Levels of Pain and Discomfort | 10 Pain score from 0-100 |
p-value: 0.001Wilcoxon (Mann-Whitney)
Secondary
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.
Time frame: immediately after treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control Arm | Number of Participants With Complete Caries Removal | 246 participants |
| Intervention Arm | Number of Participants With Complete Caries Removal | 242 participants |
Secondary
Time Use for Caries Removal
The time taken for the removal of carious dentine was recorded using a stopwatch. Recorded time unit is seconds.
Time frame: Immediately while treatment
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control Arm | Time Use for Caries Removal | 103 seconds |
| Intervention Arm | Time Use for Caries Removal | 512 seconds |
p-value: 0.001Wilcoxon (Mann-Whitney)