Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000422022
Ethics application status
Approved
Date submitted
19/05/2010
Date registered
26/05/2010
Date last updated
26/05/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of an oral health education program for mothers and fluoride treatment on oral health in Indigenous Maori children
Scientific title
Reducing disease burden and health inequalities arising from chronic disease among Indigenous children: the effect of an early childhood oral education program and fluoride treatment on oral health in indigenous Maori children
Secondary ID [1] 251802 0
None
Universal Trial Number (UTN)
None
Trial acronym
None
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Early childhood caries 257396 0
Condition category
Condition code
Public Health 257545 257545 0 0
Health promotion/education
Oral and Gastrointestinal 257573 257573 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
There will be six interactions with the research participants. The estimated time for each session is 30 minutes. (1) at recruitment; (2) baseline questionaire; (3) Intervention 6 months; (4) Intervention 12 months; (5) Intervention 18 months; (6) Follow-up questionnaire at 24 months. The mode of administration of the intervention sessions is face-to-face dialogue with individuals who may or may not be supported by other family members. These sessions will cover oral health education and promotion.
At 6 months: education regarding teething and primary teeth eruption sequences; what is early childhood caries and information about the efficacy of fluoridation; information regarding maintaining personal oranga niho (oral health) for the whanau (family).
At 12 months: education regarding healthy diets to maintain child oral health; education regarding the associations between poor oral health and other health indicators such as diabetes, coronary heart disease and obesity in adults. This follows the life course approach in that poor oral health in childhood is a predicter for poor oral health as an adult.
At 18 months: education regarding access to dental services for pre-school children; education about oral hygiene behaviours such as interdental brushing, flossing and prevention of periodontal disease. The fluoride application is 1000 ppm fluorine as sodium fluoride applied topically by dentist or school dental therapist. The infants will receive the topical fluoride at 6, 12 and 18 months of age.
Intervention code [1] 256505 0
Prevention
Comparator / control treatment
The Delayed Intervention Group will get usual dental care and then receive the interventions at 24 months
Control group
Active

Outcomes
Primary outcome [1] 258455 0
Improved oral health for young Maori infants as measured by dmft (number of decayed missing or filled teeth). The dmft index is the standard measure of dental decay which is the sum of the number of decayed, missing or filled teeth in an individual's mouth.
Timepoint [1] 258455 0
The dmft is meassured at 24 months following intervention commencement.
Secondary outcome [1] 264246 0
Improved oral health for the mother and family.
Infant dmft measured at 6, 12 and 18 months of age at a dental check up by a registered dentist or a registered school dental therapist.
The DMFT (index of caries of an adult) is not measured as we are only investigating early childhood caries.
Timepoint [1] 264246 0
The dmft is meassured at 24 months of age of the infant.

Eligibility
Key inclusion criteria
Pregnant Maori mothers within the tribal area of Waikato-Tainui.
Minimum age
16 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Non-Maori

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)
The subjects are recruited through the primary care services operated by Raukura Hauora O Tainui which is based in Hamilton.
Allocation sequence will be blocked using random length blocks and then allocation will be done using opaque sealed sequentially numbered envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
None
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 2636 0
New Zealand
State/province [1] 2636 0
Waikato

Funding & Sponsors
Funding source category [1] 256991 0
Government body
Name [1] 256991 0
Health Research Council of New Zealand
Country [1] 256991 0
New Zealand
Primary sponsor type
University
Name
UNIVERSITY OF OTAGO
Address
Po Box 913
Dunedin 9054
Country
New Zealand
Secondary sponsor category [1] 256255 0
None
Name [1] 256255 0
NONE
Address [1] 256255 0
NONE
Country [1] 256255 0
Other collaborator category [1] 1266 0
Other Collaborative groups
Name [1] 1266 0
Raukura Hauora O Tainui
Address [1] 1266 0
Raukura Hauora O Tainui
PO Box 51-58 Frankton
HAMILTON 0000
Country [1] 1266 0
New Zealand
Other collaborator category [2] 1290 0
University
Name [2] 1290 0
University of Adelaide
Address [2] 1290 0
Australian Research Centre for Population Oral Health
School of Dentistry
122 Frome Street
University of Adelaide
South Australia 5005
Country [2] 1290 0
Australia
Other collaborator category [3] 1291 0
University
Name [3] 1291 0
Universsity of Toronto
Address [3] 1291 0
Faculty of Dentistry
Universsity of Toronto
124 Edward Street
Toronto
Ontario
Canada M5G 1G6
Country [3] 1291 0
Canada

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259001 0
Northern Y Regional Ethics Committee
Ethics committee address [1] 259001 0
PO Box 1031
HAMILTON
0000
Ethics committee country [1] 259001 0
New Zealand
Date submitted for ethics approval [1] 259001 0
17/05/2010
Approval date [1] 259001 0
Ethics approval number [1] 259001 0

Summary
Brief summary
Early Childhood Caries (ECC) causes profound suffering, frequently requiring expensive treatment under a general anaesthetic. It is the strongest predictor of poor oral health in adulthood. Despite ECC being entirely preventable, marked ECC disparities exist between Maori and non-Maori children in New Zealand. If the burden of ECC and associated oral health inequalities experienced by Maori children is 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 the participants receiving the intervention benefits. Pregnant Maori women and their families will be included. 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 the mother, application of a topical fluoride to the teeth of children, anticipatory guidance and motivational interviewing. Following a kaupapa Maori research framework and methodology, the intervention will be tailored at the individual- or whanau-level, with each carer or whanau progressing to the next level only when they are ready. Developing a culturally-appropriate ECC intervention that aims to improve child oral health, in full partnership with the Maori communities involved, will provide much needed evidence for policy makers to address the challenge of improved oral health and related outcomes for Maori children.
The goal of this study is to determine whether implementation of a culturally-appropriate Early Childhood Caries (ECC) intervention utilising a kaupapa Maori methodology reduces dental disease burden and oral health inequalities among young Maori children living wthin the Waikato-Tainui tribal area. More specifically, the aim is:
Aim: To determine whether implementation of a culturally-appropriate ECC intervention, that employs a tailored approach and draws on a range of kaupapa Maori relevant contexts including oral health knowledge, oral self-care, dental service utilisation, and oral health-related self-efficacy, reduces dental disease burden and oral health inequalities among young Maori children living within the Waikato-Tainui tribal area.
Hypothesis: Exposure to a culturally-appropriate (kaupapa Maori) ECC intervention will reduce dental disease burden and oral health inequalities among young Maori children who reside within the Waikato-Tainui tribal area.
It is anticipated that implementation of a culturally-appropriate ECC intervention that aims to improve levels of oral health among tamariki Maori will, in turn, lead to improved general health outcomes. This is through (1) Maramatanga – increased understanding of the processes that lead to dental diseases and in turn, other health conditions; (2) Te Taha Tinana – a greater appreciation of the role of prevention in reducing ECC; the dietary component of which may, in turn, have benefits for other preventable, dietary-related conditions such as obesity and diabetes; (3) Te Taha Whanau – improved knowledge of lifestyle habits that are not conducive to optimim oral health; (4) Te Ara Tika – increased understanding of how to access oral health care for the whanau.
Trial website
NONE
Trial related presentations / publications
1. Broughton JR. Waiora, the water of life. Viewpoint article on Maori and fluoridation. NZ Dent J. 2008;104:144.

2. Broughton JR. Maori oral health research. Verbal presentation at the Dental Public Health Aotearoa Conference, Dunedin, April 2008.

3. Fairhall TJ, Thomson WM, Kieser JA, Broughton JR, Cullinan MP, Seymour GJ. Home or away? Differences between home- and clinic-based dental examinations for older people. Gerodontol. 2009;26:179–186.

4. Broughton JR. Oranga niho, a review of Maori oral health services utilising a kaupapa Maori methodology. Doctoral thesis, University of Otago, 2006.

5. Broughton JR. Whanaungatanga (Relationships), a key strategy for oranga niho (oral health) for tamariki Maori (Maori children) in Aotearoa/New Zealand. Verbal presentation (Invited keynote speaker) at the International Association of Paediatric Dentistry 20th International Congress, Sydney, Australia, November, 2005.

6. Thomson WM, Poulton R, Milne BJ, Caspi A, Broughton JR, Ayers KMS. Socio-economic inequalities in oral health in childhood and adulthood in a birth cohort. Community Dent Oral Epidemiol. 2004;32:1–10.

7. Thomson WM, Ayers K, Broughton JR. Child oral health inequalities in New Zealand. A background paper to the Public Health Advisory Committee, 2003. In Improving Child Oral Health and Reducing Child Health Inequalities. Report to the Minister of Health from the Public Health Advisory Committee. National Advisory Committee on Health and Disability, Wellington, May 2003.

8. Broughton JR A Kaupapa Maori Methodology: taku hikoi (My Journey). Verbal presentation the Health Research Council’s Hui Whakapiripiri, Auckland, March 2009.

9. Broughton JR Oranga Niho, A Partnership in Oral Health Research. Verbal presentation at Te Ao Marama, the New Zealand Maori Dental Association Annual Conference, Hopuhopu, Waikato, March 2009.

10. Broughton JR An Indigenous Component of Health Research in New Zealand. International Association of Dental Research 82nd General Session, Honolulu, Hawaii; March, 2004.
Public notes

Contacts
Principal investigator
Name 31179 0
Address 31179 0
Country 31179 0
Phone 31179 0
Fax 31179 0
Email 31179 0
Contact person for public queries
Name 14426 0
John R Broughton
Address 14426 0
Department of Preventive and Social Medicine
Dunedin School of Medicine
PO Box 913
DUNEDIN 9054
Country 14426 0
New Zealand
Phone 14426 0
+64 3 4797268
Fax 14426 0
+64 3 4797298
Email 14426 0
john.broughton@stonebow.otago.ac.nz
Contact person for scientific queries
Name 5354 0
John R Broughton
Address 5354 0
Department of Preventive and Social Medicine
Dunedin School of Medicine
PO Box 913
DUNEDIN 9054
Country 5354 0
New Zealand
Phone 5354 0
+64 3 4797268
Fax 5354 0
+64 3 4797298
Email 5354 0
john.broughton@stonebow.otago.ac.nz

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Results publications and other study-related documents

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