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

NCT01604109 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 296

Last updated 2013-08-15

Study results available
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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.

Conditions

  • Dental Caries

Interventions

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.

Sponsors & Collaborators

  • Fogarty International Center of the National Institute of Health

    collaborator NIH

  • Thammasat University

    lead OTHER

Principal Investigators

  • Thanya Sitthisettapong · Faculty of Dentistry, Thammasat University

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Months
Max Age
42 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2011-09-30
Completion
2011-09-30

Countries

  • Thailand

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01604109 on ClinicalTrials.gov