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Investigating the effect of a silver fluoride intervention on the life journeys of young Indigenous peoples and the arresting of dental caries across the life course

Investigating the effect of a silver fluoride intervention on the life journeys of young Indigenous peoples and the arresting of dental caries across the life course

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622001066774
Enrollment
873
Registered
2022-08-02
Start date
2023-05-08
Completion date
2024-05-23
Last updated
2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Indigenous children and adolescents experience profound levels of preventable dental disease. These impact on Indigenous children and young people’s ability to eat, speak, socialise and learn. It is a leading cause of child malnutrition and overall poor quality of life and SEWB. Trajectories of dental disease among Indigenous children/adolescents are increasing at a rate far greater than for non-Indigenous children/adolescents, with severe cases requiring care under a hospital-based general anaesthetic. Poor oral health in childhood is the leading cause of poor oral health in adulthood, and has associations with other systemic conditions including diabetes, cardiovascular disease and chronic kidney disease. Effective interventions to reduce dental disease among Indigenous children and adolescents are rare, and certainly not included in the current suite of management recommendations for the health and wellbeing of this vulnerable population. This study will test the hypothesis that Indigenous children and young people in 6 Australian states and territories can be provided with appropriate dental care in local Indigenous settings using the AgF approach, without specialist intervention and avoiding the need for treatment under hospital-based general anaesthetic. Our study has 6 major strengths: (1) it will evaluate the extent, prevalence and severity of dental disease in Indigenous children and young people in each state and territory; (2) it will test the efficacy of a simple and culturally safe AgF initiative, which could be easily implemented into the training program of Indigenous Health Workers to be included in their remit of care; (3) we will have capacity to comprehensively assess the cost-effectiveness of the intervention, meaning uptake into clinical guidelines will be much swifter than if no cost-effective analysis was undertaken; (4) the intervention will likely lead to SEWB improvements in Indigenous children and young people; an important strategic priority given current commitments to improving child health and wellbeing, with the Australian Government launching, in Oct 2021, the world’s first National Children's Mental Health and Wellbeing Strategy;1 (5) we have engaged and consulted considerably with the 9 participating ACCHOs, using their feedback to shape the research questions; (6) our researchers are world-class experts in their respective specialties and have experience working with Indigenous child and adolescent populations. Half our study team are Indigenous and include the CEOs and research officers of all ACCHOs involved. Our findings have potential to change the way in which the oral health of Indigenous children and young people is managed, with desired impacts including 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.

Interventions

The silver diamine fluoride intervention involves the application of AgF(NH3)2 38% (Riva Star) to sites of active dental caries lesions in the primary and permanent dentition. After cleaning teeth with dry gauze, dentally-qualified research officers will apply the product on decayed teeth for approximately 1 minute and allow to air dry, followed by the application of a Potassium Iodide (KI) solution to prevent staining. The application of the procedures will take approximately 5 minutes in total

The silver diamine fluoride intervention involves the application of AgF(NH3)2 38% (Riva Star) to sites of active dental caries lesions in the primary and permanent dentition. After cleaning teeth with dry gauze, dentally-qualified research officers will apply the product on decayed teeth for approximately 1 minute and allow to air dry, followed by the application of a Potassium Iodide (KI) solution to prevent staining. The application of the procedures will take approximately 5 minutes in total. Application of the product to the teeth of participants in the immediate intervention clusters will occur at the baseline visits. No strategies to monitor adherence to the intervention will be necessary.

Sponsors

The University of Adelaide
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
2 Years to 18 Years
Healthy volunteers
No

Inclusion criteria

Indigenous children and young adults aged 2 to 18 years with active carious lesions in the primary and/or permanent dentition residing in selected study clusters will be eligible.

Exclusion criteria

Participants with signs of pulp inflammation or necrosis, pulp exposure, or dental trauma involving dentin will be excluded. Carers/participants who are unable to provide written informed consent, or those with complex medical conditions or developmental syndromes, will be excluded.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026