Accepted for/Published in: JMIR Research Protocols
Date Submitted: May 1, 2023
Date Accepted: Aug 27, 2023
A silver fluoride intervention to improve oral health trajectories of young Indigenous Australians: Study Protocol for a cluster randomised clinical trial
ABSTRACT
Background:
Indigenous Australian children and adolescents experience profound levels of preventable dental disease. The application of silver fluoride (AgF) to active dental caries is a non-invasive alternative to traditional dental treatment approaches. There is particular utility among Indigenous children and young people with dental fear, who may not have access to timely or culturally safe dental service provision. The aims of this study are to: (1) assess levels of active dental caries among Indigenous children and young people in 6 Australian states and territories; (2) determine if an AgF intervention reduces levels of active disease over 12-24 months; (3) measure the impact of improved oral health on social and emotional wellbeing (SEWB) and oral health-related quality of life (OHRQoL) and; (4) calculate the cost-effectiveness of implementing such an initiative.
Objective:
No Objective
Methods:
The study will utilise a two-arm, parallel cluster randomised controlled trial design. Approximately 1140 Indigenous children and youth aged 2-18 year will be recruited. Each state/territory will have two clusters. The intervention group will receive the AgF intervention at the start of the study, with the delayed intervention group receiving the AgF intervention 12-months after study commencement. The primary outcome will be arrest of active carious lesions, with arrested caries defined as non-penetration by dental probe. Secondary outcomes will include SEWB, OHRQoL and dental anxiety, with covariates including dental behaviours (brushing, dental visits). Effectiveness measures for the economic evaluation will include the number of children and young people managed in primary oral health care without need for specialist referral, changes in SEWB, the numbers and types of treatments provided, and caries increments.
Results:
Participant recruitment will commence in May 2023. The first results are expected to be submitted for publication one year after 24-month follow-up.
Conclusions:
Our findings have potential to change the way in which active dental disease among Indigenous children and young people can be managed; through inclusion of specifically tailored AgF application to improve dental health and SEWB delivered by Indigenous health care workers. Desired impacts include cost-savings on expensive dental treatments; improved SEWB, nutrition, social and learning outcomes; and improved quality of life for both children/young people and their carers/broader Indigenous community. AgF application could be easily implemented into the training program of Indigenous Health Workers, and yield critical information in the management armamentarium of health and wellbeing recommendations for Australia’s First Peoples. Clinical Trial: ACTRN12622001066774p
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