Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12609001000291
Ethics application status
Approved
Date submitted
14/10/2009
Date registered
19/11/2009
Date last updated
19/11/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Improved dental health for remote Aboriginal children: a cluster randomised trial.
Scientific title
Among children living in remote communities does a comprehensive primary health care intervention (including fluoride varnish) compared to usual care reduce the incidence of new caries?
Universal Trial Number (UTN)
Trial acronym
STLK: Strong Teeth for Little Kids
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Early childhood caries 251998 0
Condition category
Condition code
Public Health 252191 252191 0 0
Epidemiology
Oral and Gastrointestinal 252425 252425 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
A comprehensive primary health intervention (including fluoride varnish applications every 6 months). The fluoride varnish is applied at baselines and every 6 months for a total of 2 years (5 applications). Other intervention activities also occur every 6 months- these include training of health staff in oral health promotion, identification of caries, and application of fluoride varnish, oral health promotion with individual familes, and oral health promotion with child care centres, preschools, communitiy councils, and stores.
Intervention code [1] 241409 0
Prevention
Intervention code [2] 241555 0
Other interventions
Comparator / control treatment
Standard care. Usual access to local health clinic and Children's Dental Service for any oral health problems identified over a total period of 2 years.
Control group
Active

Outcomes
Primary outcome [1] 253067 0
Caries increment (rate of new caries) assessed by dental examination.
Timepoint [1] 253067 0
2 years from baseline.
Secondary outcome [1] 257901 0
Caries increment (with adjustment of potential confounders) assessed by dental examination.
Timepoint [1] 257901 0
2 years from baseline.
Secondary outcome [2] 257902 0
Gingivitis assessed by dental examination.
Timepoint [2] 257902 0
2 years from baseline.
Secondary outcome [3] 257903 0
Dental abscess assessed by dental examination.
Timepoint [3] 257903 0
2 years from baseline.
Secondary outcome [4] 257904 0
The proportion of children undergoing a dental procedure (including fluoride varnish application) by dentist or dental therapist assessed by dental examination and review of medical records.
Timepoint [4] 257904 0
2 years from baseline.
Secondary outcome [5] 257905 0
Behavioural change as reported by parents in questionnaires completed at baseline and at 2 year follow up.
Timepoint [5] 257905 0
2 years from baseline.
Secondary outcome [6] 257906 0
Adverse events- any reaction to fluoride varnish requiring medical review. Reactions resulting in admission to hospital or considered life-threatening will be reported as serious adverse events. These will be assessed by review of medical records.
Timepoint [6] 257906 0
2 years from baseline.

Eligibility
Key inclusion criteria
Aboriginal
Aged 18m to 4y
Living in a remote community
Able to attend clinic for regular follow up
Minimum age
18 Months
Maximum age
4 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Allergy to fluoride varnish
Receiving treatment for asthma
Congenital dental disease

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)
Communities were allocated to intervention or control group. Allocation concealment was achieved by central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation sequence computer generated by statistician and concealed from all investigators, study staff and study participants
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Cluster randomised (by community)
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
700
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 243871 0
Government body
Name [1] 243871 0
National Health and Medical Research Council
Country [1] 243871 0
Australia
Primary sponsor type
University
Name
Menzies School of Health Research
Address
PO Box 41096
Darwin NT 0811
Country
Australia
Secondary sponsor category [1] 251219 0
None
Name [1] 251219 0
Address [1] 251219 0
Country [1] 251219 0
Other collaborator category [1] 904 0
University
Name [1] 904 0
Australian Research Centre for Population Oral Health
Address [1] 904 0
University of Adelaide
North Terrace
Adelaide, SA 5005
Country [1] 904 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243993 0
Human Research Committe of the NT Department of Health and Families and the Menzies School of Health Research
Ethics committee address [1] 243993 0
PO Box 41096
Darwin, NT 0811
Ethics committee country [1] 243993 0
Australia
Date submitted for ethics approval [1] 243993 0
Approval date [1] 243993 0
16/12/2005
Ethics approval number [1] 243993 0
05/70

Summary
Brief summary
Dental decay has been described as the most common disease of childhood that is not self-limiting or responsive to short-term pharmacological management. Regrettably, Australian Aboriginal children have, on average, twice as many teeth affected by decay as other Australian children. The disease is a particular burden for pre-school children who do not routinely have access to dental care provided by the state/territory programs. The goal of this project is to develop, implement and evaluate the effectiveness of a community-oriented, primary health care intervention to prevent dental decay among pre-school children in Aboriginal communities in the Northern Territory. The cluster randomized design provides a practical approach to the problem of small numbers of children living in remote communities. The results obtained from this research proposal would make an important contribution to the health care of Australian Aboriginal children and other disadvantaged children throughout the world.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30384 0
Address 30384 0
Country 30384 0
Phone 30384 0
Fax 30384 0
Email 30384 0
Contact person for public queries
Name 13631 0
Peter S Morris
Address 13631 0
Menzies School of Health Research
PO Box 41096
Darwin, NT 0811
Country 13631 0
Australia
Phone 13631 0
+61 8 89228196
Fax 13631 0
+61 8 89275187
Email 13631 0
[email protected]
Contact person for scientific queries
Name 4559 0
Peter S Morris
Address 4559 0
Menzies School of Health Research
PO Box 41096
Darwin, NT 0811
Country 4559 0
Australia
Phone 4559 0
+61 8 89228196
Fax 4559 0
+61 8 89275187
Email 4559 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.