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Completed

NCT Number: NCT01604109

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

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.

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Key information

Conditions

Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

30 month–42 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Faculty of Dentistry, Thammasat University

Klongluang, Patumthani, 12121, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

10 % w/v CPP-ACP paste

Drug

Apply once a day at school by school teacher, following fluoride toothbrushing after lunch

Other names: Tooth Mousse

the paste without CPP-ACP

Drug

Apply once a day at school by school teacher, following fluoride toothbrushing after lunch.

Primary outcomes

  1. the Mean Number of Enamel Carious Lesion

    Time frame: one calender year

    tooth surface that was classified as ICDAS code 1-3

Secondary outcomes

  1. Quantitative Light-induced Fluorescence (QLF) Parameters

    Time frame: one calender year

    percent fluorescence loss, lesion area, lesion volume

Sponsors and collaborators

Lead sponsor

Thammasat University

Other

Collaborators

  • Fogarty International Center of the National Institute of Health

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
May 23, 2012
Registry last updated
Aug 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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