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

Thammasat University

Status and phase: Completed; Phase 2

Conditions: Dental Caries

Treatments: Drug: the paste without CPP-ACP; Drug: 10 % w/v CPP-ACP paste

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01604109

TU-Dent-01

D43TW007768 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 296 patients

Sex: All

Ages: 30 to 42 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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296 participants in 2 patient groups, including a placebo group

Tooth Mousse

Active Comparator group

Description:

10% w/v Calcium Phosphopeptide Amorphous Calcium Phosphate paste

Treatment:

Drug: 10 % w/v CPP-ACP paste

placebo control paste

Placebo Comparator group

Description:

the paste without Calcium phosphopeptide - Amorphous Calcium Phosphate

Treatment:

Drug: the paste without CPP-ACP