Dental Caries
Conditions
Keywords
Caries detection/diagnosis/prevention, Preventive Dentistry, Casien Phosphopeptide, Remineralization, Clinical trial
Brief summary
The purpose of this study is to determine if adding daily application of CPP-ACP containing paste for one year is superior to regular fluoride tooth brushing in preventing dental caries in high caries risk Thai preschool children.
Detailed description
The 6th National Oral Health Survey in Thailand 2006-2007 reported that 3-year-old children who resided in central part have the highest dental caries prevalence of 69.8 percent with dmft affecting 3.63 teeth on average. Fluoride is widely accepted as the most effective tool to caries prevention for initial caries lesions. Current best practice recommends twice-daily tooth brushing with fluoride toothpaste for dentate children. CPP-ACP can bolster the effects of fluoridated toothpaste alone to prevent caries.Currently, almost all clinical trials have investigated the effectiveness of CPP-ACP containing products in dental caries prevention and enhancing remineralization of initial carious lesion in the permanent dentition of young adolescents. There are no clinical studies of the effect of a CPP-ACP containing product to prevent dental caries in the primary dentition of young children.
Interventions
DRUG10 % w/v CPP-ACP paste
Apply once a day at school by school teacher, following fluoride toothbrushing after lunch
DRUGthe paste without CPP-ACP
Apply once a day at school by school teacher, following fluoride toothbrushing after lunch.
Sponsors
Fogarty International Center of the National Institute of Health
Thammasat University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Months to 42 Months
Healthy volunteers
Yes
Inclusion criteria
* Healthy Thai boys and girl aged between 2 1/2 - 3 1/2 * Normal development of dentition * Diagnosed as high caries risk by using the Caries-risk Assessment Tool(CAT)
Exclusion criteria
* Chronic use of medications or antibiotics. * Lack of cooperation in oral examination * Milk protein allergy and/or benzoate preservatives * Presence at baseline oral soft tissue lesion and enamel hypoplasia. * Receive fluoride supplement and professional topical fluoride application at least three months before the beginning of study or during study period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the Mean Number of Enamel Carious Lesion | one calender year | tooth surface that was classified as ICDAS code 1-3 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quantitative Light-induced Fluorescence (QLF) Parameters | one calender year | percent fluorescence loss, lesion area, lesion volume |
Countries
Thailand
Participant flow
Recruitment details
The study took place in the central part of Thailand, where water \[F\]\<0.1 ppm. The recruitment began in June 2010. There were 304 healthy Thai boys and girls from ten public nursery schools enrolled in the study. The baseline examination was performed at school in July-August, 2010.
Pre-assignment details
Six children were excluded from the study because they did not complete the inclusion criteria: autism (1), milk protein allergy (1), taking fluoride table (1), and no high caries risk (3).
Participants by arm
| Arm | Count |
|---|---|
| Tooth Mousse 10% w/v Calcium Phosphopeptide Amorphous Calcium Phosphate paste
10 % w/v CPP-ACP paste : Apply once a day at school by school teacher, following fluoride toothbrushing after lunch | 150 |
| Placebo Control Paste the paste without Calcium phosphopeptide - Amorphous Calcium Phosphate
the paste without CPP-ACP : Apply once a day at school by school teacher, following fluoride toothbrushing after lunch. | 146 |
| Total | 296 |
Baseline characteristics
| Characteristic | Placebo Control Paste | Tooth Mousse | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 146 Participants | 150 Participants | 296 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age Continuous | 3.10 years STANDARD_DEVIATION 0.25 | 3.08 years STANDARD_DEVIATION 0.24 | 3.09 years STANDARD_DEVIATION 0.24 |
| Region of Enrollment Thailand | 146 participants | 150 participants | 296 participants |
| Sex: Female, Male Female | 75 Participants | 78 Participants | 153 Participants |
| Sex: Female, Male Male | 71 Participants | 72 Participants | 143 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 150 | 0 / 146 |
| serious Total, serious adverse events | 0 / 150 | 0 / 146 |
Outcome results
Primary
the Mean Number of Enamel Carious Lesion
tooth surface that was classified as ICDAS code 1-3
Time frame: one calender year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tooth Mousse | the Mean Number of Enamel Carious Lesion | 13.69 Surfaces | Standard Deviation 7.94 |
| Placebo Control Paste | the Mean Number of Enamel Carious Lesion | 14.55 Surfaces | Standard Deviation 9.56 |
Secondary
Quantitative Light-induced Fluorescence (QLF) Parameters
percent fluorescence loss, lesion area, lesion volume
Time frame: one calender year