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

This study has been completed.
Sponsor:
Collaborator:
John E. Fogarty International Center (FIC)
Information provided by (Responsible Party):
Thanya Sitthisettapong, Thammasat University
ClinicalTrials.gov Identifier:
NCT01604109
First received: May 19, 2012
Last updated: May 22, 2012
Last verified: May 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Dental Caries
 Drug: 10 % w/v CPP-ACP paste
Drug: the paste without CPP-ACP
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of CPP-ACP Paste on Dental Caries in Primary Teeth: A Randomized Trial

Resource links provided by NLM:

MedlinePlus related topics: Tooth Decay
U.S. FDA Resources

Further study details as provided by Thammasat University:

Primary Outcome Measures:
  • the mean number of enamel carious lesion [ Time Frame: one calender year ] [ Designated as safety issue: No ]
    tooth surface that was classified as ICDAS code 1-3


Secondary Outcome Measures:
  • Quantitative Light-induced Fluorescence (QLF) parameters [ Time Frame: one calender year ] [ Designated as safety issue: No ]
    percent fluorescence loss, lesion area, lesion volume


Enrollment: 296
Study Start Date: July 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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.

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.

  Eligibility

Ages Eligible for Study:   30 Months to 42 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01604109

Locations
Thailand
Faculty of Dentistry, Thammasat University
Klongluang, Patumthani, Thailand, 12121
Sponsors and Collaborators
Thammasat University
John E. Fogarty International Center (FIC)
Investigators
Principal Investigator: Thanya Sitthisettapong Faculty of Dentistry, Thammasat University
  More Information

No publications provided

Responsible Party: Thanya Sitthisettapong, Faculty of Dentistry, Thammasat University
ClinicalTrials.gov Identifier: NCT01604109     History of Changes
Other Study ID Numbers: TU-Dent-01, D43TW007768
Study First Received: May 19, 2012
Last Updated: May 22, 2012
Health Authority: Thailand: Ethical Committee

Keywords provided by Thammasat University:
Caries detection/diagnosis/prevention
Preventive Dentistry
Casien Phosphopeptide
Remineralization
Clinical trial

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on May 21, 2013