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

NCT ID: NCT01604109

Last Updated: 2013-08-15

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

296 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2011-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Dental Caries

Keywords

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Caries detection/diagnosis/prevention Preventive Dentistry Casien Phosphopeptide Remineralization Clinical trial

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Tooth Mousse

10% w/v Calcium Phosphopeptide Amorphous Calcium Phosphate paste

Group Type ACTIVE_COMPARATOR

10 % w/v CPP-ACP paste

Intervention Type DRUG

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

placebo control paste

the paste without Calcium phosphopeptide - Amorphous Calcium Phosphate

Group Type PLACEBO_COMPARATOR

the paste without CPP-ACP

Intervention Type DRUG

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

Interventions

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10 % w/v CPP-ACP paste

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

Intervention Type DRUG

the paste without CPP-ACP

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

Intervention Type DRUG

Other Intervention Names

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Tooth Mousse

Eligibility Criteria

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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
Minimum Eligible Age

30 Months

Maximum Eligible Age

42 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fogarty International Center of the National Institute of Health

NIH

Sponsor Role collaborator

Thammasat University

OTHER

Sponsor Role lead

Responsible Party

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Thanya Sitthisettapong

Faculty of Dentistry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Thanya Sitthisettapong

Role: PRINCIPAL_INVESTIGATOR

Faculty of Dentistry, Thammasat University

Locations

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Faculty of Dentistry, Thammasat University

Klongluang, Patumthani, Thailand

Site Status

Countries

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Thailand

References

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Sitthisettapong T, Phantumvanit P, Huebner C, Derouen T. Effect of CPP-ACP paste on dental caries in primary teeth: a randomized trial. J Dent Res. 2012 Sep;91(9):847-52. doi: 10.1177/0022034512454296. Epub 2012 Jul 17.

Reference Type DERIVED
PMID: 22805294 (View on PubMed)

Other Identifiers

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D43TW007768

Identifier Type: NIH

Identifier Source: secondary_id

View Link

TU-Dent-01

Identifier Type: -

Identifier Source: org_study_id