Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000356561
Ethics application status
Approved
Date submitted
11/08/2006
Date registered
18/08/2006
Date last updated
8/06/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Preventive Strategies for Early Childhood Caries (ECC) from Antenatal to age 24 months
Scientific title
A randomised phase III study to evaluate the effects of chlorhexidine toothpaste and Casein Phosphopeptide – Amorphous Calcium Phosphate (Tooth Mousse) in the treatment of condition Early Childhood Caries to prevent carious lesions in deciduous teeth.
Secondary ID [1] 295146 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Early childhood caries 1326 0
Condition category
Condition code
Oral and Gastrointestinal 1414 1414 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 Casein Phosphopeptide – Amorphous Calcium Phosphate (Tooth Mousse) or 0.2% Chlorhexidine toothpaste from eruption of first tooth until child is 24 months of age.
Intervention code [1] 1228 0
Prevention
Comparator / control treatment
Control group is Toothbrushing daily with only low dose fluoride toothpaste
Control group
Active

Outcomes
Primary outcome [1] 1935 0
Less numbers of carious lesions and/or demineralised tooth surfaces as detected through visual examination
Timepoint [1] 1935 0
When child is 24 months
Secondary outcome [1] 3395 0
Lower levels of decy causing bacteria in their saliva.
Timepoint [1] 3395 0
When the child is 24 months old.

Eligibility
Key inclusion criteria
Pregnant women and new mothers in the Logan-Beaudesert Health Service District.
Minimum age
12 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Children with milk protein allergies (due to reaction to preventive agent to be used).

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
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Introduction of water fluoridation to the community was announced for December 2008. Recruitment ceased before this time so all participants were born pre- water fluoridation introduction.
Date of first participant enrolment
Anticipated
1/10/2006
Actual
12/01/2007
Date of last participant enrolment
Anticipated
Actual
30/06/2008
Date of last data collection
Anticipated
Actual
30/04/2011
Sample size
Target
3960
Accrual to date
Final
1017
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 1546 0
Government body
Name [1] 1546 0
Oral Health Program, Logan-Beaudesert Health Service District, Queensland Health
Country [1] 1546 0
Australia
Primary sponsor type
Government body
Name
Oral Health Program, Logan-Beaudesert Health Service District, Queensland Health
Address
Kingston Oral Health Centre, Juers St Kingston, QLD, 4114
Country
Australia
Secondary sponsor category [1] 1359 0
None
Name [1] 1359 0
Nil
Address [1] 1359 0
Country [1] 1359 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5440 0
PAHREC
Ethics committee address [1] 5440 0
Ipswich Road Woolloongabba
Ethics committee country [1] 5440 0
Date submitted for ethics approval [1] 5440 0
Approval date [1] 5440 0
03/10/2008
Ethics approval number [1] 5440 0
2006/145

Summary
Brief summary
This project aims to determine the best preventive methods for ECC by assessing variations of strategies. The strategies that will be used are
• Education classes to antenatal and new parent groups
• Preventive agents – participants will be randomly assigned to the following groups: toothbrushing with low-dose fluoride toothpaste, toothbrushing with 0.2 percent chlorhexidine gel, and toothbrushing with casein-phosphoprotein gel (CPP-ACP, Tooth Mousse)
• Support through home visits and phone calls

The effectiveness of these strategies will be assessed through
• Pre and post questionnaires including dental knowledge, feeding practices and oral hygiene practices
• Microbial analysis for the presence of decay-causing bacteria (blinded)
• Dental screen analysis of participants having home visits (calibrated operators, not blinded)
• Dental screen analysis at the 2 year recall (blinded)
• Statistical analysis of data for case and control groups

Participants will be recruited either from antenatal classes, pre-registration for maternity ward or new parent classes. All participants will be recalled when their child is approximately 6-9 months, 9-12 months and 15-18 months either through the home visit or by telephone. All will be asked to attend an appointment at the 24-26 month recall with their child.

Swab samples of the teeth and gums will be taken and tested for the presence of decay-causing bacteria (mutans streptococci) and general oral bacteria in which participants will be informed of the results. The Mother’s teeth will be wiped with sterile cotton-tipped swabs at the initial contact, when the child is born and at the final recall. Those who wish to participate in home visits will also have their teeth swabbed at the 6-9 month period and their child’s teeth will be swabbed when their child is 6-9 months, 9-12 months and 15-18 months.

Resources such as toothbrushes and preventive products will be supplied free of charge for the duration of participation or until the child is 24-26 months.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35108 0
Dr Kathryn Elsworthy
Address 35108 0
UQ Oral Health Centre, 288 Herston Road, Herston QLD 4006
Country 35108 0
Australia
Phone 35108 0
+61 7 3365 8183
Fax 35108 0
Email 35108 0
[email protected]
Contact person for public queries
Name 10417 0
Dr Dr Kathryn Elsworthy
Address 10417 0
UQ Oral Health Centre, 288 Herston Road, Herston QLD 4006
Country 10417 0
Australia
Phone 10417 0
+61 7 3365 8183
Fax 10417 0
+61 7 3365 8199
Email 10417 0
[email protected]
Contact person for scientific queries
Name 1345 0
Dr Dr Kathryn Elsworthy
Address 1345 0
UQ Oral Health Centre, 288 Herston Road, Herston QLD 4006
Country 1345 0
Australia
Phone 1345 0
+61 7 3365 8183
Fax 1345 0
+61 7 3365 8199
Email 1345 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.