Phase 2 N=296 Quadruple-blind Prevention

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

Dental Caries

Bottom Line

View on ClinicalTrials.gov: NCT01604109 ↗

Enrolled (actual)

296

Serious AEs

0.0%

Results posted

Aug 2013

Primary outcome: Primary: the Mean Number of Enamel Carious Lesion — 13.69; 14.55 Surfaces

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: 10 % w/v CPP-ACP paste (Drug); the paste without CPP-ACP (Drug)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: Thammasat University
Primary completion: Sep 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY the Mean Number of Enamel Carious Lesion	13.69; 14.55	—
SECONDARY Quantitative Light-induced Fluorescence (QLF) Parameters	—	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01604109). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.