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

Phase 2

Completed

• Conditions: Dental Caries
• Interventions: Drug: 10 % w/v CPP-ACP paste; Drug: the paste without CPP-ACP

• Registration Number: NCT01604109
• Lead Sponsor: Thammasat University

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.

Study Timeline

• Study Start: 2010-07
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Study First Submitted: 2012-05-19
• Study First Submitted QC: 2012-05-22
• Study First Posted: 2012-05-23
• Status Verified: 2013-06
• Results First Submitted: 2013-06-10
• Results First Submitted QC: 2013-06-10
• Last Update Submitted: 2013-06-10
• Results First Posted: 2013-08-15
• Last Update Posted: 2013-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 296

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tooth Mousse	10 % w/v CPP-ACP paste	10% w/v Calcium Phosphopeptide Amorphous Calcium Phosphate paste
placebo control paste	the paste without CPP-ACP	the paste without Calcium phosphopeptide - Amorphous Calcium Phosphate

Primary Outcome Measures

Name	Time	Method
the Mean Number of Enamel Carious Lesion	one calender year	tooth surface that was classified as ICDAS code 1-3

Secondary Outcome Measures

Name	Time	Method
Quantitative Light-induced Fluorescence (QLF) Parameters	one calender year	percent fluorescence loss, lesion area, lesion volume

Trial Locations

Locations (1)

Faculty of Dentistry, Thammasat University; 🇹🇭 Klongluang, Patumthani, Thailand