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Trial registered on ANZCTR


Registration number
ACTRN12622001066774p
Ethics application status
Not yet submitted
Date submitted
15/07/2022
Date registered
2/08/2022
Date last updated
2/08/2022
Date data sharing statement initially provided
2/08/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
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
Scientific title
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
Secondary ID [1] 307578 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dental caries 327027 0
Early childhood caries 327028 0
Condition category
Condition code
Oral and Gastrointestinal 324199 324199 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
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.
Intervention code [1] 324030 0
Prevention
Intervention code [2] 324031 0
Treatment: Other
Comparator / control treatment
Standard course of dental care, which involves the family of the participant organising and transporting the child/adolescent for either public or privately-funded dental care. Participants in the delayed intervention group will receive the intervention at the 12-month follow-up
Control group
Active

Outcomes
Primary outcome [1] 332015 0
Arrest of carious lesions in the dentition, with arrested caries defined as non-penetration by dental probe.
Timepoint [1] 332015 0
12 months (primary timepoint) and 24 months after intervention
Secondary outcome [1] 411905 0
Socio and Emotional Wellbeing (SEWB) will be measured using the Strengths and Difficulties Questionnaire (SDQ).
Timepoint [1] 411905 0
12 months and 24 months after intervention
Secondary outcome [2] 411907 0
Dental anxiety will be assessed using the Child Dental Anxiety and Scale modified to capture anxiety from adolescent participants.
Timepoint [2] 411907 0
12 months and 24 months after the intervention.
Secondary outcome [3] 411908 0
Dental behaviours: tooth brushing frequency, assessed using items from the 2012-14 National Child Oral Health Survey.
Timepoint [3] 411908 0
12 months and 24 months after the intervention.
Secondary outcome [4] 412448 0
Dental behaviours: use of fluoride toothpaste, assessed using items from the 2012-14 National Child Oral Health Survey.
Timepoint [4] 412448 0
12 months and 24 months after the intervention.
Secondary outcome [5] 412449 0
Dental behaviours: usual reason for participant to visit oral health care provider, assessed using items from the 2012-14 National Child Oral Health Survey.
Timepoint [5] 412449 0
12 months and 24 months after the intervention.
Secondary outcome [6] 412450 0
Dental behaviours: consumption of sugar-sweetened beverages and foods, assessed using items from the 2012-14 National Child Oral Health Survey.
Timepoint [6] 412450 0
12 months and 24 months after intervention.
Secondary outcome [7] 412451 0
Effectiveness measures for economic evaluation: number of children and young people managed in primary oral health care without need for specialist referral. This will be determined based on self-reported information on utilisation of dental services and clinical evaluation of need for specialist referral.
Timepoint [7] 412451 0
12 months and 24 months after intervention.
Secondary outcome [8] 412452 0
Effectiveness measures for economic evaluation: changes in SEWB measured using the questionnaires General Child Health Utility Scale, Child Health Utility 9D Index (CHU_9D), and the proxy reporting of the EQ-5D-Y tool.
Timepoint [8] 412452 0
12 months and 24 months after intervention.
Secondary outcome [9] 412453 0
Effectiveness measures for economic evaluation: the numbers and types of treatments provided, and caries increments. This will be determined based on clinical evaluation.
Timepoint [9] 412453 0
12 months and 24 months after intervention.

Eligibility
Key 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.
Minimum age
2 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generator (computer-generated block randomised algorithm). The random allocation will be 1:1 per state and territory; that is, one cluster per state/territory will be randomly allocated as the intervention site, leaving the other cluster to be the delayed intervention site. Randomisation will be done prior to baseline fieldwork. Field staff will have no access to the randomisation algorithm, thus allowing the randomisation process to be audited.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Delayed intervention design. All participants ultimately receive the benefits of the intervention. The intervention group will receive the treatment during baseline. The control group will receive the intervention after a year of the application of the product to the intervention group.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Based on the literature, in which approximately 81% of carious lesions were estimated to have been arrested with AgF, the community intra-cluster correlation was calculated as 0.09. Using these parameters at 80% power, alpha at 0.05 and 12 clusters available (6 clusters per treatment arm), the estimated sample size required is 320 in each arm. Allowing for 25% loss to follow-up each year, the estimated sample size is 570 per arm or 95 children/
adolescents per cluster (rounded up). We were unable to source any literature demonstrating the effect size (and clinical relevance) from dental interventions on SEWB. However, we have been collecting SDQ data in our South Australian Aboriginal Birth Cohort study for the past 5 years. At last data collection (participant mean age 10 years), the mean SDQ score for boys was 12.6, with a SD of 6.2. Achieving a 3-unit change in SDQ (that is, from 12.6 to 9.6, with 9.6 being in the normative range for boys for the Australian child population for SDQ data), the required sample size at a significance criterion of 0.05, power of 0.80 and with 6 clusters in each trial arm is 22 per cluster, which equates to 35 per cluster allowing for 25 percent participant loss each year (n=210 boys per study arm). The mean SDQ score for girls was 10.5, with a SD of 6.1. Achieving a 3-unit change in SDQ (from 10.5 to 7.5, with 7.5 being in the normative range for girls from the Australian child population for SDQ data), at a significance criterion of 0.05, power of 0.80 and with 6 clusters per trial arm would require 18 per cluster, which equates to 28 per cluster allowing for 25 percent participant loss each year (n=168 girls per study arm). A baseline sample size of 1140 will thus yield sufficient power to undertake the primary and secondary analyses as well as other sub-group analyses. Sample size estimations were undertaken on STATA 15 using the commands for cluster randomised trials for proportions of caries arrest and means for SDQ. Data analysis will use intention-to-treat approaches, with standard imputation measures used to manage missing data.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/07/2023
Actual
Date of last participant enrolment
Anticipated
4/12/2023
Actual
Date of last data collection
Anticipated
7/12/2026
Actual
Sample size
Target
1140
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,NT,QLD,SA,WA,VIC
Recruitment postcode(s) [1] 38126 0
0850 - Katherine
Recruitment postcode(s) [2] 38129 0
2650 - Wagga Wagga
Recruitment postcode(s) [3] 38128 0
2800 - Orange
Recruitment postcode(s) [4] 38130 0
3381 - Halls Gap
Recruitment postcode(s) [5] 38127 0
4870 - Bungalow
Recruitment postcode(s) [6] 38124 0
5690 - Ceduna
Recruitment postcode(s) [7] 38125 0
5723 - Coober Pedy
Recruitment postcode(s) [8] 38123 0
6530 - Geraldton

Funding & Sponsors
Funding source category [1] 311775 0
Government body
Name [1] 311775 0
National Health and Medical Research Council
Country [1] 311775 0
Australia
Primary sponsor type
University
Name
The University of Adelaide
Address
Adelaide 5000 SA
Country
Australia
Secondary sponsor category [1] 313325 0
None
Name [1] 313325 0
Address [1] 313325 0
Country [1] 313325 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 311216 0
Aboriginal Health Research Ethics Committee
Ethics committee address [1] 311216 0
220 Franklin Street, Adelaide SA 5000
Ethics committee country [1] 311216 0
Australia
Date submitted for ethics approval [1] 311216 0
10/10/2022
Approval date [1] 311216 0
Ethics approval number [1] 311216 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 120362 0
Mrs Joanne Hedges
Address 120362 0
The University of Adelaide, Level 4, 50 Rundle Mall, Adelaide, South Australia, 5000
Country 120362 0
Australia
Phone 120362 0
+61 0431 524 995
Fax 120362 0
Email 120362 0
joanne.hedges@adelaide.edu.au
Contact person for public queries
Name 120363 0
Prof Lisa Jamieson
Address 120363 0
The University of Adelaide, Level 4, 50 Rundle Mall, Adelaide, South Australia, 5000
Country 120363 0
Australia
Phone 120363 0
+61 8 8313 4611
Fax 120363 0
Email 120363 0
lisa.jamieson@adelaide.edu.au
Contact person for scientific queries
Name 120364 0
Prof Lisa Jamieson
Address 120364 0
The University of Adelaide, Level 4, 50 Rundle Mall, Adelaide, South Australia, 5000
Country 120364 0
Australia
Phone 120364 0
+61 8 8313 4611
Fax 120364 0
Email 120364 0
lisa.jamieson@adelaide.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Due to ethical restrictions, individual participant data will not be made publicly available.


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.