Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000457549p
Ethics application status
Not yet submitted
Date submitted
25/03/2024
Date registered
15/04/2024
Date last updated
26/05/2024
Date data sharing statement initially provided
15/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of Silver fluoride in managing baby tooth dental decay among Aboriginal children in remote communities
Scientific title
Efficacy of Silver Fluoride and Teledentistry to manage and prevent childhood dental decay among Aboriginal children in remote communities
Secondary ID [1] 311758 0
NHMRC APP2025089
Universal Trial Number (UTN)
U1111-1307-6743
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dental decay in primary teeth 333261 0
Condition category
Condition code
Oral and Gastrointestinal 329950 329950 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Public Health 330098 330098 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Test participants will have silver fluoride (AgF) solution, 0.05 ml, sufficent to treat 5 teeth (38% or 40% AgF, randomly selected to receive either the 38% or 40% AgF) applied onto decayed tooth surfaces on primary molars and surfaces at risk of decay by an Aboriginal Health Practitioner. The solution will be applied using a micro-brush and applied for 60 seconds per lesion, once only. Teeth treated with silver fluoride will be further randomly allocated to receive additional application of potassium iodide (0.10 ml) applied with a micro-brush or no additional treatment. Potassium iodide will be applied until the white creamy precipitate which forms turns clear to test for the stain reducing effects of potassium iodide. The lesions will be monitored annually for 2 years and silver fluoride and potassium iodide re-applied, if necessary. Participant dental records will be reviewed for attendance and receipt of treatment.
Intervention code [1] 328213 0
Treatment: Devices
Comparator / control treatment
The control children will be provided with care for the decayed teeth by treatment using standard minimally invasive treatments comprising Atraumatic Restorative Treatment (ART) procedures and/or Hall Technique 9HT) crowns and fluoride varnish applied to surfaces at risk of decay. For ART, the tooth will be prepared using hand instruments to remove decay, without local anaesthetic, and the prepared cavity restored with glass ionomer cement. For HT, no tooth preparation will be undertaken, debris will be removed from the cavity and the tooth restored with a stainless steel crown, cemented with a glass-ionomer cement. Fluoride varnish (0.04 ml, 5 % NaF, sufficient for the entire dentition) will be applied to at risk tooth surfaces using a micro-brush. Treatments will be provided by dental therapists and the children reviewed annually for 2 years and further treatment provided as required.
Control group
Active

Outcomes
Primary outcome [1] 337710 0
Arrested dental decay
Timepoint [1] 337710 0
Participants will be followed-up for 2 years and have the tooth surface status assessed at 12-month intervals after baseline assessment and treatment.
Primary outcome [2] 337711 0
Occurrence of new dental decay on surfaces designated as sound at baseline.
Timepoint [2] 337711 0
Tooth surfaces will be assessed at 12-month intervals for 2 years post-baseline.
Secondary outcome [1] 432924 0
The number of teeth experiencing dental infections.
Timepoint [1] 432924 0
The assessments will be undertaken at each 12-month follow-ups for 2 years post-baseline.
Secondary outcome [2] 433106 0
Changes in child oral health-related quality of life
Timepoint [2] 433106 0
The questionniare will be completed at each 12-month followup for the 2 years of follow-up after baseline.
Secondary outcome [3] 433730 0
Changes in childhood dental anxiety
Timepoint [3] 433730 0
The questionniare will be completed at each 12-month followup for the 2 years of follow-up after baseline.

Eligibility
Key inclusion criteria
Aboriginal children aged 0.5-7 years of age, both with or without dental decay.
Minimum age
6 Months
Maximum age
7 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Children with developmental conditions which may inhibit cooperating for dental treatment and children presenting with acute dental conditions requiring urgent care.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Computer-generated randomisation. Assignment will be by central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Communities are the unit of assignment and will be stratified on caries experience from a previous study. Assignment will be generated through computer-generated block randomisation procedure.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Communities will be randomly assigned to silver fluoride or standard care treatment options. Children provided with silver treatment will be further randomised to be treated with either potassium iodide in combination with silver fluoride or just silver fluoride alone to assess the stain reducing effects of potassium iodide.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/03/2025
Actual
Date of last participant enrolment
Anticipated
28/11/2025
Actual
Date of last data collection
Anticipated
31/12/2027
Actual
Sample size
Target
620
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 316091 0
Government body
Name [1] 316091 0
National Health and Medical Research Council
Country [1] 316091 0
Australia
Funding source category [2] 316092 0
Government body
Name [2] 316092 0
WA Health Major Research Application Support program
Country [2] 316092 0
Australia
Funding source category [3] 316093 0
Charities/Societies/Foundations
Name [3] 316093 0
Stan Perron Charitable Foundation Research Programs and Partnership Grant
Country [3] 316093 0
Australia
Primary sponsor type
Government body
Name
WA Dental Health Services
Address
Country
Australia
Secondary sponsor category [1] 318259 0
University
Name [1] 318259 0
University of Western Australia Dental School
Address [1] 318259 0
Country [1] 318259 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 314913 0
Child and Adolescent Health Service Human Research Ethics Committee
Ethics committee address [1] 314913 0
Ethics committee country [1] 314913 0
Australia
Date submitted for ethics approval [1] 314913 0
01/07/2024
Approval date [1] 314913 0
Ethics approval number [1] 314913 0
Ethics committee name [2] 314914 0
The University of Western Australia Human Research Ethics Committee
Ethics committee address [2] 314914 0
Ethics committee country [2] 314914 0
Australia
Date submitted for ethics approval [2] 314914 0
01/08/2024
Approval date [2] 314914 0
Ethics approval number [2] 314914 0
Ethics committee name [3] 314915 0
Western Australian Aboriginal Health Ethics Committee
Ethics committee address [3] 314915 0
Ethics committee country [3] 314915 0
Australia
Date submitted for ethics approval [3] 314915 0
02/09/2024
Approval date [3] 314915 0
Ethics approval number [3] 314915 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 133130 0
Dr peter arrow
Address 133130 0
WA Dental Health Services, 43 Mt Henry Road, Salter Point, 6152, Western Australia
Country 133130 0
Australia
Phone 133130 0
+61 08 93130600
Fax 133130 0
Email 133130 0
[email protected]
Contact person for public queries
Name 133131 0
peter arrow
Address 133131 0
WA Dental Health Services, 43 Mt Henry Road, Salter Point, 6152, Western Australia
Country 133131 0
Australia
Phone 133131 0
+61 08 93130600
Fax 133131 0
Email 133131 0
[email protected]
Contact person for scientific queries
Name 133132 0
peter arrow
Address 133132 0
WA Dental Health Services, 43 Mt Henry Road, Salter Point, 6152, Western Australia
Country 133132 0
Australia
Phone 133132 0
+61 08 93130600
Fax 133132 0
Email 133132 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.