NCT01604109

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
296

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2010

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 19, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 23, 2012

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

August 15, 2013

Completed
Last Updated

August 15, 2013

Status Verified

June 1, 2013

Enrollment Period

1.2 years

First QC Date

May 19, 2012

Results QC Date

June 10, 2013

Last Update Submit

June 10, 2013

Conditions

Dental Caries

Keywords

Caries detection/diagnosis/preventionPreventive DentistryCasien PhosphopeptideRemineralizationClinical trial

Outcome Measures

Primary Outcomes (1)

  • the Mean Number of Enamel Carious Lesion

    tooth surface that was classified as ICDAS code 1-3

    one calender year

Secondary Outcomes (1)

  • Quantitative Light-induced Fluorescence (QLF) Parameters

    one calender year

Study Arms (2)

Tooth Mousse

ACTIVE COMPARATOR

10% w/v Calcium Phosphopeptide Amorphous Calcium Phosphate paste

Drug: 10 % w/v CPP-ACP paste

placebo control paste

PLACEBO COMPARATOR

the paste without Calcium phosphopeptide - Amorphous Calcium Phosphate

Drug: the paste without CPP-ACP

Interventions

10 % w/v CPP-ACP pasteDRUG

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

Also known as: Tooth Mousse
Tooth Mousse
the paste without CPP-ACPDRUG

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

placebo control paste

Eligibility Criteria

Age30 Months - 42 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Thammasat University

Klongluang, Patumthani, 12121, Thailand

Location

Related Publications (1)

  • 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.

    PMID: 22805294DERIVED

MeSH Terms

Conditions

Dental Caries

Interventions

casein phosphopeptide-amorphous calcium phosphate nanocomplex

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Limitations and Caveats

This one year study was performed on high caries risk pre-school children who enrolled in government nursery schools in central part of Thailand.

Results Point of Contact

Title
Thanya Sitthisettapong
Organization
ThammasatU
thanyasang@yahoo.com
6629869213

Study Officials

  • Thanya Sitthisettapong

    Faculty of Dentistry, Thammasat University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Faculty of Dentistry

Study Record Dates

First Submitted

May 19, 2012

First Posted

May 23, 2012

Study Start

July 1, 2010

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

August 15, 2013

Results First Posted

August 15, 2013

Record last verified: 2013-06

Locations

TH(1)