NCT01604109

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 296 (actual)
• Sponsor: Thammasat University · Academic / Other
• Sex: All
• Age: 30 Months – 42 Months
• Healthy volunteers: Accepted

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.

Conditions

• Dental Caries

Interventions

Type	Name	Description
DRUG	10 % w/v CPP-ACP paste	Apply once a day at school by school teacher, following fluoride toothbrushing after lunch
DRUG	the paste without CPP-ACP	Apply once a day at school by school teacher, following fluoride toothbrushing after lunch.

Timeline

• Start date: 2010-07-01
• Primary completion: 2011-09-01
• Completion: 2011-09-01
• First posted: 2012-05-23
• Last updated: 2013-08-15
• Results posted: 2013-08-15

Locations

1 site across 1 country: Thailand