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Trial registered on ANZCTR


Registration number
ACTRN12609000330246
Ethics application status
Approved
Date submitted
2/04/2009
Date registered
22/05/2009
Date last updated
24/07/2019
Date data sharing statement initially provided
24/07/2019
Date results information initially provided
24/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A controlled longitudinal study of caries prevention in children aged 2 to 4 years
Scientific title
A randomised longitudinal phase III study to evaluate the effects of chlorhexidine toothpaste and Casein Phosphopeptide - Amorphous Calcium Phosphate (CPP-ACP Tooth Mousse) in the treatment of condition Early Childhood Caries to prevent carious lesions in deciduous teeth
Universal Trial Number (UTN)
Trial acronym
ECC2-4
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Early Childhood Caries 4554 0
Condition category
Condition code
Oral and Gastrointestinal 4847 4847 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Toothbrushing daily only with low dose fluoride toothpaste or in combination with either CPP-ACP Tooth Mousse or 0.2% chlorhexidine toothpaste from 2 to four years of age.
Intervention code [1] 4320 0
Prevention
Comparator / control treatment
Control group is toothbrushing daily with only low dose fluoride toothpaste
Control group
Active

Outcomes
Primary outcome [1] 5704 0
Less numbers of carious lesions and/ or demineralised tooth surfaces as detected through visual examination
Timepoint [1] 5704 0
When child is 48 months old
Secondary outcome [1] 241619 0
Lower levels of decay causing bacteria as detected through Caries Risk Test (CRT) Bacteria Test by Ivoclar
Timepoint [1] 241619 0
When child is 48 months old

Eligibility
Key inclusion criteria
All mothers who completed research Study "Preventive Strategies for Early Childhood Caries from Antenatal to age 24 months"
Minimum age
16 Years
Maximum age
70 Years
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Children with milk protein allergies will be removed from the intervention group of Tooth mousse and continue with the control group

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealed by opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using procedures such as coin tossing and dice rolling
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 14300 0
Logan Hospital - Meadowbrook
Recruitment postcode(s) [1] 27298 0
4131 - Meadowbrook

Funding & Sponsors
Funding source category [1] 4746 0
Government body
Name [1] 4746 0
Oral Health Program, Logan Beaudesert Area, Metro South Health Service District
Address [1] 4746 0
Kingston Oral Health Centre, Juers St Kingston QLD 4114
Country [1] 4746 0
Australia
Primary sponsor type
Government body
Name
Oral Health Program, Logan Beaudesert Area, Metro South Health Service District
Address
Kingston Oral Health Centre, Juers St Kingston QLD 4114
Country
Australia
Secondary sponsor category [1] 4286 0
None
Name [1] 4286 0
Address [1] 4286 0
Country [1] 4286 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6785 0
Princess Alexandra Hospital HREC
Ethics committee address [1] 6785 0
Ipswich Road, Woolloongabba, Qld 4102
Ethics committee country [1] 6785 0
Australia
Date submitted for ethics approval [1] 6785 0
30/04/2009
Approval date [1] 6785 0
06/08/2009
Ethics approval number [1] 6785 0
HREC/09/QPAH/158
Ethics committee name [2] 303904 0
Dental Sciences Research Ethics Committee
Ethics committee address [2] 303904 0
200 Turbot St Brisbane QLD 4000
Ethics committee country [2] 303904 0
Australia
Date submitted for ethics approval [2] 303904 0
30/10/2009
Approval date [2] 303904 0
02/12/2009
Ethics approval number [2] 303904 0
0913

Summary
Brief summary
In this study, we will be continuing to follow participants recruited for the research project “Preventive Strategies for Early Childhood Caries from Antenatal to age 24 months" Princess Alexandra (PA) Ethics no. 2006/145, and Australian Clinical Trials Registry (ACTR) registration number ACTRN012606000356561 who have undergone preventative methods of education, home visits and toothbrushing with low-dose fluoride toothpaste, 0.2% chlorhexidine gel and casein-phosphopeptide amorphous calcium phosphate (CPP-ACP, ToothMousse).

The effectiveness of these strategies will be assessed through
- Pre- and post questionnaires
- microbial analysis for the presence of decay causing bacteria
- dental screen analysis for all participants at age 3 and 4
- statistical analysis of data for case and control groups
Trial website
Trial related presentations / publications
Plonka, KA, Pukallus, ML, Barnett, AG, Holcombe, TF, Walsh, LJ & Seow, WK (2013a). A longitudinal case-control study of caries development from birth to 36 months. Caries Research 47(2): 117-127.
Public notes

Contacts
Principal investigator
Name 29459 0
Dr Kathryn Elsworthy
Address 29459 0
UQ Oral Health Centre, 288 Herston Road, Herston QLD 4006
Country 29459 0
Australia
Phone 29459 0
+61 7 3365 8183
Fax 29459 0
+61 7 3365 8199
Email 29459 0
k.elsworthy@uq.edu.au
Contact person for public queries
Name 12706 0
Dr Kathryn Elsworthy
Address 12706 0
UQ Oral Health Centre, 288 Herston Road, Herston QLD 4006
Country 12706 0
Australia
Phone 12706 0
+61 7 3365 8183
Fax 12706 0
+61 7 3365 8199
Email 12706 0
k.elsworthy@uq.edu.au
Contact person for scientific queries
Name 3634 0
Dr Kathryn Elsworthy
Address 3634 0
UQ Oral Health Centre, 288 Herston Road, Herston QLD 4006
Country 3634 0
Australia
Phone 3634 0
+61 7 3365 8183
Fax 3634 0
+61 7 3365 8199
Email 3634 0
k.elsworthy@uq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data contains identifiable information
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
Yes
Journal publication details
Publication date and citation/details [1] 1949 0
Plonka, KA, Pukallus, ML, Barnett, AG, Holcombe, TF, Walsh, LJ & Seow, WK (2013a). A longitudinal case-control study of caries development from birth to 36 months. Caries Research 47(2): 117-127.
Attachments [1] 1949 0
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary
The prevalence of early childhood caries was surprisingly low and believed to be as a result of the health promotion that was associated with the study. The effectiveness of the therapeutic interventions in preventing caries were not evident.