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

Primary Purpose

Dental Caries

Status

Completed

Phase

Phase 2

Locations

Thailand

Study Type

Interventional

Intervention

10 % w/v CPP-ACP paste

the paste without CPP-ACP

About this trial

This is an interventional prevention trial for Dental Caries focused on measuring Caries detection/diagnosis/prevention, Preventive Dentistry, Casien Phosphopeptide, Remineralization, Clinical trial

Eligibility Criteria

30 Months - 42 Months (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Faculty of Dentistry, Thammasat University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Tooth Mousse

placebo control paste

Arm Description

10% w/v Calcium Phosphopeptide Amorphous Calcium Phosphate paste

the paste without Calcium phosphopeptide - Amorphous Calcium Phosphate

Outcomes

Primary Outcome Measures

the Mean Number of Enamel Carious Lesion

tooth surface that was classified as ICDAS code 1-3

Secondary Outcome Measures

Quantitative Light-induced Fluorescence (QLF) Parameters

percent fluorescence loss, lesion area, lesion volume

Full Information

NCT ID

NCT01604109

First Posted

May 19, 2012

Last Updated

June 10, 2013

Sponsor

Thammasat University

Collaborators

Fogarty International Center of the National Institute of Health

1. Study Identification

Unique Protocol Identification Number

NCT01604109

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2013

Overall Recruitment Status

Completed

Study Start Date

July 2010 (undefined)

Primary Completion Date

September 2011 (Actual)

Study Completion Date

September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Thammasat University

Collaborators

Fogarty International Center of the National Institute of Health

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dental Caries

Keywords

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Non-Randomized

Enrollment

296 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tooth Mousse

Arm Type

Active Comparator

Arm Description

10% w/v Calcium Phosphopeptide Amorphous Calcium Phosphate paste

Arm Title

placebo control paste

Arm Type

Placebo Comparator

Arm Description

the paste without Calcium phosphopeptide - Amorphous Calcium Phosphate

Intervention Type

Drug

Intervention Name(s)

10 % w/v CPP-ACP paste

Other Intervention Name(s)

Tooth Mousse

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

the paste without CPP-ACP

Intervention Description

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

Primary Outcome Measure Information:

Title

the Mean Number of Enamel Carious Lesion

Description

tooth surface that was classified as ICDAS code 1-3

Time Frame

one calender year

Secondary Outcome Measure Information:

Title

Quantitative Light-induced Fluorescence (QLF) Parameters

Description

percent fluorescence loss, lesion area, lesion volume

Time Frame

one calender year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Months

Maximum Age & Unit of Time

42 Months

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thanya Sitthisettapong

Organizational Affiliation

Faculty of Dentistry, Thammasat University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Faculty of Dentistry, Thammasat University

City

Klongluang

State/Province

Patumthani

ZIP/Postal Code

12121

Country

Thailand

12. IPD Sharing Statement

Citations:

PubMed Identifier

22805294

Citation

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.

Results Reference

derived

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

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