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Trial registered on ANZCTR
Registration number
ACTRN12611000111976
Ethics application status
Approved
Date submitted
20/12/2010
Date registered
1/02/2011
Date last updated
26/04/2018
Type of registration
Prospectively registered
Titles & IDs
Public title
Reducing disease burden and health inequalities arising from chronic dental disease among Indigenous children: an early childhood caries intervention
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Scientific title
Reducing disease burden and health inequalities arising from chronic dental disease among Indigenous children: an early childhood caries intervention
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Secondary ID [1]
253317
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Early Childhood Caries
258853
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Condition category
Condition code
Oral and Gastrointestinal
258992
258992
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0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Public Health
259210
259210
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0
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Health promotion/education
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Intervention comprises four components; provision of dental care to mother during pregnancy, fluoride varnish application to teeth of children, motivational interviewing and anticipatory guidance.
Dental care will comprise of extractions, restorations, scaling and prophylaxis, will be one-on-one with a dentist, and will take as many visits as required to achieve a non-diseased mouth.
Fluoride varnish application to teeth of children in the intervention group will occur when children are aged 6-, 12- and 18-months. Children in the delayed-intervention group will receive fluoride varnish application at 24-, 30- and 36 months. Application will be one-on-one by a trained research officer.
Motivational interviewing for those in the intervention group will occur during pregnancy and when child is aged 6-, 12- and 18-months. Mothers in the delayed-intervention group will receive motivational interviewing when the child is aged at 24-, 30- and 36 months. Each session will last 1-1.5 hours.
Anticipatory guidance for those in the intervention group will occur during pregnancy and when child is aged 6-, 12- and 18-months. Mothers in the delayed-intervention group will receive anticipatory guidance when the child is aged at 24-, 30- and 36 months. Each session will last 15 minutes.
The dental care intervention will be stand-alone, but the motivational interviewing and anticipatory guidance will be conducted during the same sessions as fluoride varnish application.
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Intervention code [1]
257771
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Prevention
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Intervention code [2]
257944
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Treatment: Other
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Comparator / control treatment
Standard treatment, which usually involves provision of dental care only if participant is in pain and is the holder of a health care card.
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Control group
Active
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Outcomes
Primary outcome [1]
259843
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The prevalence of early childhood caries. This will be assessed using clinical measures by a registered dental practitioner.
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Assessment method [1]
259843
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Timepoint [1]
259843
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Child aged two years and child aged three years
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Secondary outcome [1]
268703
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Carer oral health knowledge, which will be assessed by self-report questionnaire.
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Assessment method [1]
268703
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Timepoint [1]
268703
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Child aged two years and child aged three years
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Secondary outcome [2]
268704
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Carer oral self care, which will be assessed by self-report questionnaire.
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Assessment method [2]
268704
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Timepoint [2]
268704
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Child aged two years and child aged three years
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Secondary outcome [3]
268705
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Carer dental service utilisation, which will be assessed by self-report questionnaire.
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Assessment method [3]
268705
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Timepoint [3]
268705
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Child aged two years and child aged three years
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Secondary outcome [4]
268706
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Carer oral health-related self-efficacy, which will be assessed by self-report questionnaire.
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Assessment method [4]
268706
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Timepoint [4]
268706
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Child aged two years and child aged three years
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Secondary outcome [5]
268707
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Carer oral health literacy, which will be assessed by self-report questionnaire.
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Assessment method [5]
268707
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Timepoint [5]
268707
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Child aged two years and child aged three years
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Secondary outcome [6]
334027
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Average daily energy intake as assessed by 3x 24-hour diet recalls.
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Assessment method [6]
334027
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Timepoint [6]
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Child aged 2 years.
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Secondary outcome [7]
335087
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Food and nutrient intake assessed by Food Frequency Questionnaires
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Assessment method [7]
335087
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Timepoint [7]
335087
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Child aged 3 years
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Secondary outcome [8]
346135
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Food and nutrient intake assessed by Food Frequency Questionnaire when child is aged 3 years.
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Assessment method [8]
346135
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Timepoint [8]
346135
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Food and nutrient intake assessed by Food Frequency Questionnaire when child is aged 5 years
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Eligibility
Key inclusion criteria
Women who are pregnant with an Aboriginal child who live in the designated study area (South Australia).
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Minimum age
No limit
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Those who are not pregnant with an Aboriginal child or who do not live in the designated study area
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subject enrolled through ante-natal units, GP referrals and general word-of-mouth
Random allocation to intervention or control group occurs through central randomisation by computer
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer algorithm
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
Delayed intervention design; all participants ultimate receive the benefits of the intervention.
The intervention group receive the intervention from when the mother is pregnant until when the child is two years old. The delayed intervention group receive the intervention from when the child is two years old to when the child is three years old.
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
31/01/2011
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Actual
1/02/2011
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Date of last participant enrolment
Anticipated
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Actual
31/05/2012
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Date of last data collection
Anticipated
15/12/2017
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Actual
22/12/2017
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Sample size
Target
448
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Accrual to date
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Final
446
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
7880
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Womens and Childrens Hospital - North Adelaide
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Recruitment hospital [2]
7881
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Lyell McEwin Hospital - Elizabeth Vale
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Recruitment hospital [3]
7882
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Flinders Medical Centre - Bedford Park
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Recruitment postcode(s) [1]
15825
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5006 - North Adelaide
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Recruitment postcode(s) [2]
15826
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5112 - Elizabeth Vale
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Recruitment postcode(s) [3]
15827
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5042 - Bedford Park
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Funding & Sponsors
Funding source category [1]
258236
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Government body
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Name [1]
258236
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National Health and Medical Research Council
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Address [1]
258236
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GPO Box 1421
Canberra ACT 2601
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Country [1]
258236
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Australia
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Primary sponsor type
University
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Name
University of Adelaide
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Address
Level 9, Adelaide Health and Medical Sciences Building
57 North Terrace,
Adelaide, South Australia 5005
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Country
Australia
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Secondary sponsor category [1]
257403
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None
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Name [1]
257403
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Address [1]
257403
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Country [1]
257403
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
260217
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University of Adelaide Human Research Ethics Committee
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Ethics committee address [1]
260217
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Research Branch
Research Ethics and Compliance Unit
University of Adelaide
SA 5005
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Ethics committee country [1]
260217
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Australia
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Date submitted for ethics approval [1]
260217
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Approval date [1]
260217
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03/06/2010
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Ethics approval number [1]
260217
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H-057-2010
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Summary
Brief summary
Early Childhood Caries (ECC) causes profound suffering, frequently requiring expensive treatment under a general anaesthetic. It is associated with other chronic childhood conditions such as otitis media and nutritional disorders, and is the strongest predictor of poor oral health in adulthood. Despite ECC being entirely preventable, marked ECC disparities exist between Indigenous and non-Indigenous children in Australia. If the burden of ECC and associated oral health inequalities experienced by Indigenous children are to be reduced, more needs to be done to ensure that appropriate preventive measures, together with support for maintaining optimal oral health, are provided to carers of such children in the early life stages. This will be an interventional study, with all participants receiving the intervention benefits. The intervention will be implemented from birth and continue for the first three years of a participating child’s life. It will involve four components; dental care provided to mother during pregnancy, application of topical fluoride to the teeth of children, anticipatory guidance and motivational interviewing. Developing a culturally-appropriate ECC intervention that aims to improve child oral health will provide much needed evidence for policy makers to address the challenge of improved oral health and related outcomes for Indigenous children.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
32031
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Prof Lisa M. Jamieson
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Address
32031
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Australian Research Centre for Population Oral Health
The University of Adelaide
Level 9, Adelaide Health and Medical Sciences Building
57 North Terrace,
Adeaide, South Australia 5005
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Country
32031
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Australia
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Phone
32031
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+61883134611
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Fax
32031
0
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Email
32031
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[email protected]
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Contact person for public queries
Name
15278
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Prof Lisa Jamieson
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Address
15278
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Australian Research Centre for Population Oral Health
The University of Adelaide
Level 9, Adelaide Health and Medical Sciences Building
57 North Terrace,
Adeaide, South Australia 5005
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Country
15278
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Australia
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Phone
15278
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+61883134611
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Fax
15278
0
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Email
15278
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[email protected]
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Contact person for scientific queries
Name
6206
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Prof Lisa Jamieson
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Address
6206
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Australian Research Centre for Population Oral Health
The University of Adelaide
Level 9, Adelaide Health and Medical Sciences Building
57 North Terrace,
Adeaide, South Australia 5005
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Country
6206
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Australia
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Phone
6206
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+61 8 8303 4611
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Fax
6206
0
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Email
6206
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[email protected]
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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
Source
Title
Year of Publication
DOI
Embase
Follow-up of Intervention to Prevent Dental Caries among Indigenous Children in Australia: A Secondary Analysis of a Randomized Clinical Trial.
2019
https://dx.doi.org/10.1001/jamanetworkopen.2019.15611
Embase
Cohort profile: South Australian Aboriginal Birth Cohort (SAABC)-a prospective longitudinal birth cohort.
2021
https://dx.doi.org/10.1136/bmjopen-2020-043559
Embase
Child-, Family-, and Community-Level Facilitators for Promoting Oral Health Practices among Indigenous Children.
2022
https://dx.doi.org/10.3390/ijerph19031150
Embase
Dietary Intake and Anthropometric Measurement at Age 36 Months among Aboriginal and/or Torres Strait Islander Children in Australia: A Secondary Analysis of the Baby Teeth Talk Randomized Clinical Trial.
2021
https://dx.doi.org/10.1001/jamanetworkopen.2021.14348
Dimensions AI
Reducing disease burden and health inequalities arising from chronic disease among indigenous children: an early childhood caries intervention in Aotearoa/New Zealand
2013
https://doi.org/10.1186/1471-2458-13-1177
N.B. These documents automatically identified may not have been verified by the study sponsor.
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