Effect of CPP-ACP Paste on Dental Caries in Primary Teeth

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of CPP-ACP Paste on Dental Caries in Primary Teeth: A Randomized Trial

Conditions
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Dental Caries

Intervention / Treatment
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* Drug: 10 % w/v CPP-ACP paste
* Drug: the paste without CPP-ACP


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Months
Maximum Age: 42 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tooth Mousse<br>10% w/v Calcium Phosphopeptide Amorphous Calcium Phosphate paste | Drug: 10 % w/v CPP-ACP paste<br>* Apply once a day at school by school teacher, following fluoride toothbrushing after lunch<br>* Other names: Tooth Mousse;|
| Placebo Comparator: placebo control paste<br>the paste without Calcium phosphopeptide - Amorphous Calcium Phosphate | Drug: the paste without CPP-ACP<br>* Apply once a day at school by school teacher, following fluoride toothbrushing after lunch.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the Mean Number of Enamel Carious Lesion | tooth surface that was classified as ICDAS code 1-3 | one calender year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantitative Light-induced Fluorescence (QLF) Parameters | percent fluorescence loss, lesion area, lesion volume | one calender year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Caries detection/diagnosis/prevention, Preventive Dentistry, Casien Phosphopeptide, Remineralization, Clinical trial