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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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.


Sponsor: Thammasat University

Current Primary Outcome: the Mean Number of Enamel Carious Lesion [ Time Frame: one calender year ]

tooth surface that was classified as ICDAS code 1-3


Original Primary Outcome: Same as current

Current Secondary Outcome: Quantitative Light-induced Fluorescence (QLF) Parameters [ Time Frame: one calender year ]

percent fluorescence loss, lesion area, lesion volume


Original Secondary Outcome: Same as current

Information By: Thammasat University

Dates:
Date Received: May 19, 2012
Date Started: July 2010
Date Completion:
Last Updated: June 10, 2013
Last Verified: June 2013