ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

None

Trial acronym

None

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Early childhood caries

Condition category

Condition code

Public Health

Health promotion/education

Oral and Gastrointestinal

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]

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]

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]

The dmft is meassured at 24 months following intervention commencement.

Secondary outcome [1]

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]

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]

New Zealand

State/province [1]

Waikato

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Health Research Council of New Zealand

Address [1]

Po Box 5541 Wellesley Street AUCKLAND 1141

Country [1]

New Zealand

Primary sponsor type

University

Name

UNIVERSITY OF OTAGO

Address

Po Box 913
Dunedin 9054

Country

New Zealand

Secondary sponsor category [1]

None

Name [1]

NONE

Address [1]

NONE

Country [1]

Other collaborator category [1]

Other Collaborative groups

Name [1]

Raukura Hauora O Tainui

Address [1]

Raukura Hauora O Tainui PO Box 51-58 Frankton HAMILTON 0000

Country [1]

New Zealand

Other collaborator category [2]

University

Name [2]

University of Adelaide

Address [2]

Australian Research Centre for Population Oral Health School of Dentistry 122 Frome Street University of Adelaide South Australia 5005

Country [2]

Australia

Other collaborator category [3]

University

Name [3]

Universsity of Toronto

Address [3]

Faculty of Dentistry Universsity of Toronto 124 Edward Street Toronto Ontario Canada M5G 1G6

Country [3]

Canada

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Northern Y Regional Ethics Committee

Ethics committee address [1]

PO Box 1031
HAMILTON
0000

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

17/05/2010

Approval date [1]

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

John R Broughton

Address

Department of Preventive and Social Medicine Dunedin School of Medicine PO Box 913 DUNEDIN 9054

Country

New Zealand

Phone

+64 3 4797268

Fax

+64 3 4797298

[email protected]

Contact person for scientific queries

Name

John R Broughton

Address

Department of Preventive and Social Medicine Dunedin School of Medicine PO Box 913 DUNEDIN 9054

Country

New Zealand

Phone

+64 3 4797268

Fax

+64 3 4797298

[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.

Trial Review

Documents added manually

Documents added automatically