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

June 10, 2013 updated by: Thanya Sitthisettapong, Thammasat University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

296

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Patumthani
      • Klongluang, Patumthani, Thailand, 12121
        • Faculty of Dentistry, Thammasat University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Tooth Mousse
10% w/v Calcium Phosphopeptide Amorphous Calcium Phosphate paste
Drug: 10 % w/v CPP-ACP paste
Apply once a day at school by school teacher, following fluoride toothbrushing after lunch
Other Names:
  • Tooth Mousse
Placebo Comparator: placebo control paste
the paste without Calcium phosphopeptide - Amorphous Calcium Phosphate
Drug: the paste without CPP-ACP
Apply once a day at school by school teacher, following fluoride toothbrushing after lunch.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the Mean Number of Enamel Carious Lesion
Time Frame: one calender year
tooth surface that was classified as ICDAS code 1-3
one calender year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantitative Light-induced Fluorescence (QLF) Parameters
Time Frame: one calender year
percent fluorescence loss, lesion area, lesion volume
one calender year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thammasat University

Collaborators

Fogarty International Center of the National Institute of Health

Investigators

  • Principal Investigator: Thanya Sitthisettapong, Faculty of Dentistry, Thammasat University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

May 19, 2012

First Submitted That Met QC Criteria

May 22, 2012

First Posted (Estimate)

May 23, 2012

Study Record Updates

Last Update Posted (Estimate)

August 15, 2013

Last Update Submitted That Met QC Criteria

June 10, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TU-Dent-01
  • D43TW007768 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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