Phase 2
Completed N=296
Effect of CPP-ACP Paste on Dental Caries in Primary Teeth
Source: ClinicalTrials.gov NCT01604109 ↗Enrolled (actual)
296
Serious AEs
0.0%
Results posted
Aug 2013
Primary outcomePrimary: the Mean Number of Enamel Carious Lesion — 13.69; 14.55 Surfaces
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.
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 |
— | — |
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
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. Informational only — not medical advice.