A Silver Fluoride Intervention to Improve Oral Health Trajectories of Young Indigenous Australians: Protocol for a Cluster Randomized Controlled Trial.

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 noninvasive 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 provisions. OBJECTIVE: 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 well-being (SEWB) and oral health-related quality of life; and (4) calculate the cost-effectiveness of implementing such an initiative. METHODS: The study will use a 2-arm, parallel cluster randomized controlled trial design. Approximately 1140 Indigenous children and youth aged between 2 and 18 years will be recruited. Each state or territory will have 2 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 the arrest of active carious lesions, with arrested caries defined as nonpenetration by a dental probe. Secondary outcomes will include SEWB, oral health-related quality of life, and dental anxiety, with covariates including dental behaviors (brushing and dental visits). Effectiveness measures for the economic evaluation will include the number of children and young people managed in primary oral health care without the 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 1 year after a 24-month follow-up. CONCLUSIONS: Our findings have the potential to change the way in which active dental disease among Indigenous children and young people can be managed through the inclusion of specifically tailored AgF applications 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 and young people and their caregivers and the broader Indigenous community. The 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 well-being recommendations for Australia's First Peoples. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/48558.

The Indigenous Australian Human Papillomavirus (HPV) Cohort Study 2, Continuation for 5 to 10 Years: Protocol for a Longitudinal Study.

BACKGROUND: Human papillomavirus (HPV) infection, a common sexually transmitted disease, is associated with cancers of the cervix, vulva, vagina, penis, anus, and head and neck. Oropharyngeal squamous cell carcinoma (OPSCC; throat cancer) is a type of cancer involving the head and neck area that is rapidly increasing across the globe. There are higher rates of OPSCC among Indigenous populations relative to non-Indigenous Australian populations, although the HPV-attributable fraction remains unknown. For the first time at a global level, we plan to extend an Indigenous Australian adult cohort to monitor, screen, and ultimately prevent HPV-associated OPSCC and to undertake extensive cost-effectiveness modelling around HPV vaccination. OBJECTIVE: This study aims to (1) extend follow-up to a minimum of 7 years post recruitment to describe the prevalence, incidence, clearance, and persistence of oral HPV infection; and (2) conduct clinical examinations of the head and neck, oral cavity, and oropharynx and collect saliva samples for early-stage OPSCC testing. METHODS: We will continue to implement a longitudinal design for the next study phase, where we will ascertain the prevalence, incidence, clearance, and persistence of oral HPV infection at 48, 60, and 72 months; undertake clinical examinations/saliva assessments to detect early-stage OPSCC; and refer for treatment. The primary outcome measures are changes in oral HPV infection status, biomarker measures of early HPV-related cancer, and clinical evidence of early-stage OPSCC. RESULTS: Participant 48-month follow-up will commence in January 2023. The first results are expected to be submitted for publication 1 year after 48-month follow-up begins. CONCLUSIONS: Our findings have potential to change the way in which OPSCC among Australian Indigenous adults is managed, with desired impacts including cost-savings on expensive cancer treatments; improved nutritional, social, and emotional outcomes; and improved quality of life for both Indigenous adults and the Indigenous community more broadly. Continuing a large, representative Indigenous adult cohort to track oral HPV infection and monitor early OPSCC is essential to yield critical information to include in the management armamentarium of health and well-being recommendations for Australia's First Nations. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/44593.

Provision of Dental Care to Indigenous South Australians and Impacts on Improved General Health: Study Protocol.

BACKGROUND: Indigenous South Australians carry a disproportionate burden of dental diseases, with approximately 80 percent of Indigenous adults having both periodontal disease and dental caries. The chronic inflammatory nature of many dental conditions means there are widespread systemic impacts, particularly on type 2 diabetes, chronic kidney disease and cardiovascular disease. Evidence suggests there are barriers experienced by Indigenous South Australians in accessing timely and culturally safe dental care. This study aims to: (1) elicit the views of Indigenous South Australians regarding their perspectives of what comprises culturally safe dental care; (2) provide such dental care and; (3) assess any changes in both oral and general health using point-of-care testing following receipt of timely, comprehensive and culturally safe dental care. METHODS/DESIGN: This mixed-methods study will involve qualitative interviews and an intervention without randomisation. The qualitative component will comprise seeking perspectives of Indigenous South Australians regarding what culturally safe dental care means for them. For the intervention component, participants will take part in oral epidemiological examinations at baseline and 12-month follow-up (after receipt of dental care), which will include collection of saliva, plaque and calculus, as well as completion of a self-report questionnaire. The primary outcome measures-changes in type 2 diabetes (HbA1c), cardiovascular disease (CRP) and chronic kidney disease (ACR)-will be obtained by blood/urine spot from a finger prick/urine collection at baseline and 12-month follow-up via point-of-care testing. RESULTS: Participant recruitment will commence in July 2022. The first results are expected to be submitted for publication one year after recruitment begins. DISCUSSION: The project will have a number of important outcomes, including increased understanding of what culturally safe dental care means for Indigenous South Australians, the delivery of such care, and empirical evidence of how culturally safe dental care leads to better prognosis for chronic diseases linked with poor oral health. This will be important for health services planning, especially in the Aboriginal Community Controlled Health Organisation sector, where the management of dental diseases in a culturally safe manner for better chronic disease outcomes is currently insufficiently understood, planned and budgeted for.

Maximizing Oral Health Outcomes of Aboriginal and Torres Strait Islander People With End-stage Kidney Disease Through Culturally Secure Partnerships: Protocol for a Mixed Methods Study.

BACKGROUND: Dialysis for end-stage kidney disease (ESKD) is the leading cause of hospitalization among Aboriginal and Torres Strait Islander individuals in Australia. Poor oral health is commonly the only obstacle preventing Aboriginal and Torres Strait Islander people with ESKD in Australia from receiving kidney transplant. OBJECTIVE: This study aims to improve access, provision, and delivery of culturally secure dental care for Aboriginal and Torres Strait Islander individuals with ESKD in South Australia through the following objectives: investigate the facilitators of and barriers to providing oral health care to Aboriginal and Torres Strait Islander patients with ESKD in South Australia; investigate the facilitators of and barriers to maintaining oral health among Aboriginal and Torres Strait Islander people with ESKD in South Australia; facilitate access to and completion of culturally secure dental care for Aboriginal and Torres Strait Islander individuals with ESKD and their families; provide oral health promotion training for Aboriginal health workers (AHWs) at each of the participating Aboriginal Community Controlled Health Services, with a specific emphasis on oral health needs of patients with ESKD; generate co-designed strategies to better facilitate access to and provision of culturally secure dental services for Aboriginal and Torres Strait Islander people living with ESKD; and evaluate participant progress and AHW oral health training program. METHODS: This collaborative study is divided into 3 phases: exploratory phase (baseline), intervention phase (baseline), and evaluation phase (after 6 months). The exploratory phase will involve collaboration with stakeholders in different sectors to identify barriers to providing oral health care; the intervention phase will involve patient yarns, patient oral health journey mapping, clinical examinations, culturally secure dental care provision, and strategy implementation workshops; and the evaluation phase will involve 6-month follow-up clinical examinations, participant evaluations of dental care provision, and AHW evaluation of oral health training. RESULTS: Stakeholder interviews were initiated in November 2021, and participant recruitment commenced in February 2022. The first results are expected to be submitted for publication in December 2022. CONCLUSIONS: Expected outcomes will identify the burden of oral disease experienced by Aboriginal and Torres Strait Islander people with ESKD in South Australia. Qualitative outcomes are expected to develop a deeper appreciation of the unique challenges regarding oral health for individuals with ESKD. Through stakeholder engagement, responsive strategies and policies will be co-designed to address participant-identified and stakeholder-identified challenges to ensure accessibility to culturally secure dental services for Aboriginal and Torres Strait Islander individuals with ESKD. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/39685.