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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
Scientific title
Reducing disease burden and health inequalities arising from chronic dental disease among Indigenous children: an early childhood caries intervention
Secondary ID [1] 253317 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Early Childhood Caries 258853 0
Condition category
Condition code
Oral and Gastrointestinal 258992 258992 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Public Health 259210 259210 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 257771 0
Prevention
Intervention code [2] 257944 0
Treatment: Other
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.
Control group
Active

Outcomes
Primary outcome [1] 259843 0
The prevalence of early childhood caries. This will be assessed using clinical measures by a registered dental practitioner.
Timepoint [1] 259843 0
Child aged two years and child aged three years
Secondary outcome [1] 268703 0
Carer oral health knowledge, which will be assessed by self-report questionnaire.
Timepoint [1] 268703 0
Child aged two years and child aged three years
Secondary outcome [2] 268704 0
Carer oral self care, which will be assessed by self-report questionnaire.
Timepoint [2] 268704 0
Child aged two years and child aged three years
Secondary outcome [3] 268705 0
Carer dental service utilisation, which will be assessed by self-report questionnaire.
Timepoint [3] 268705 0
Child aged two years and child aged three years
Secondary outcome [4] 268706 0
Carer oral health-related self-efficacy, which will be assessed by self-report questionnaire.
Timepoint [4] 268706 0
Child aged two years and child aged three years
Secondary outcome [5] 268707 0
Carer oral health literacy, which will be assessed by self-report questionnaire.
Timepoint [5] 268707 0
Child aged two years and child aged three years
Secondary outcome [6] 334027 0
Average daily energy intake as assessed by 3x 24-hour diet recalls.
Timepoint [6] 334027 0
Child aged 2 years.
Secondary outcome [7] 335087 0
Food and nutrient intake assessed by Food Frequency Questionnaires
Timepoint [7] 335087 0
Child aged 3 years
Secondary outcome [8] 346135 0
Food and nutrient intake assessed by Food Frequency Questionnaire when child is aged 3 years.
Timepoint [8] 346135 0
Food and nutrient intake assessed by Food Frequency Questionnaire when child is aged 5 years

Eligibility
Key inclusion criteria
Women who are pregnant with an Aboriginal child who live in the designated study area (South Australia).
Minimum age
No limit
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Those who are not pregnant with an Aboriginal child or who do not live in the designated study area

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)
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
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer algorithm
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
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.
Phase
Not Applicable
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)
SA
Recruitment hospital [1] 7880 0
Womens and Childrens Hospital - North Adelaide
Recruitment hospital [2] 7881 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment hospital [3] 7882 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 15825 0
5006 - North Adelaide
Recruitment postcode(s) [2] 15826 0
5112 - Elizabeth Vale
Recruitment postcode(s) [3] 15827 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 258236 0
Government body
Name [1] 258236 0
National Health and Medical Research Council
Address [1] 258236 0
GPO Box 1421
Canberra ACT 2601
Country [1] 258236 0
Australia
Primary sponsor type
University
Name
University of Adelaide
Address
Level 9, Adelaide Health and Medical Sciences Building
57 North Terrace,
Adelaide, South Australia 5005
Country
Australia
Secondary sponsor category [1] 257403 0
None
Name [1] 257403 0
Address [1] 257403 0
Country [1] 257403 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260217 0
University of Adelaide Human Research Ethics Committee
Ethics committee address [1] 260217 0
Research Branch
Research Ethics and Compliance Unit
University of Adelaide
SA 5005
Ethics committee country [1] 260217 0
Australia
Date submitted for ethics approval [1] 260217 0
Approval date [1] 260217 0
03/06/2010
Ethics approval number [1] 260217 0
H-057-2010

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32031 0
Prof Lisa M. Jamieson
Address 32031 0
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
Country 32031 0
Australia
Phone 32031 0
+61883134611
Fax 32031 0
Email 32031 0
lisa.jamieson@adelaide.edu.au
Contact person for public queries
Name 15278 0
Prof Lisa Jamieson
Address 15278 0
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
Country 15278 0
Australia
Phone 15278 0
+61883134611
Fax 15278 0
Email 15278 0
lisa.jamieson@adelaide.edu.au
Contact person for scientific queries
Name 6206 0
Prof Lisa Jamieson
Address 6206 0
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
Country 6206 0
Australia
Phone 6206 0
+61 8 8303 4611
Fax 6206 0
Email 6206 0
lisa.jamieson@adelaide.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary