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
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
Trial website
Trial related presentations / publications
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
[email protected]
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
[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.