Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001041741p
Ethics application status
Submitted, not yet approved
Date submitted
25/05/2022
Date registered
26/07/2022
Date last updated
29/05/2025
Date data sharing statement initially provided
26/07/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Testing root caries arrest with silver diamine fluoride: an effectiveness trial in public oral health care settings
Scientific title
Testing root caries arrest with silver diamine fluoride: an effectiveness trial in public oral health care settings
Secondary ID [1] 307163 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dental caries 326370 0
Condition category
Condition code
Oral and Gastrointestinal 323667 323667 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
This study will measure the effectiveness of silver diamine fluoride (SDF) solution in arresting dental root caries and assessing the colour of arrested caries lesions at 12 months after 2 applications: one at baseline and a second one at 6 months follow up of dentine/root caries in older adults living in a fluoridated area, to a control group.
Accordingly, the study will compare caries arrest activity of root caries lesions after exposure to:

a. Group 1 - SDI Riva Star Aqua Step 1 (AgF)
b. Group 2- Control
Against a control (status-quo) group.
The control group will receive the current standard care/conventional dental treatment.
This study will provide answers to the following research question:
1. What is the effect on caries arrest activity by silver fluoride solution compared to conventional care? (Ho: there is no difference in the effectiveness of the methods in arresting root caries when compared to conventional care).

Additionally, to obtain a more comprehensive understanding of the caries arrest approach, an evaluation will also be undertaken to investigate:
3. Oral Health Professionals (OHP) views on root caries management strategies; and
4. participating patients’ opinions on the approach;
5. barriers and facilitators to root caries management strategies program uptake.
Intervention code [1] 323616 0
Treatment: Other
Comparator / control treatment
Control group will receive conventional dental treatment. For example, drilling and filling or, pulpotomy, or tooth extractions.

The frequency of conventional dental treatment and duration of clinic visits is based on treatment needs.
Control group
Active

Outcomes
Primary outcome [1] 331415 0
Root caries arrest rate Root caries will be assessed clinically by oral health professionals (i.e., visual and tactile inspection). A hard and shiny surface represents an arrested lesion.
Timepoint [1] 331415 0
Baseline; 6 months and 12 months (primary endpoint) post-treatment commencement
Secondary outcome [1] 412036 0
Colour change of arrested caries lesions. Colour of the arrested root caries lesion will be classified into one of four categories according to PANTONE1 colour plates placed next to the lesion, Namely, yellow (7401U), light brown (1245U), dark brown (4635U), and black (BlackU).
Timepoint [1] 412036 0
6 months and 12 months post-treatment commencement
Secondary outcome [2] 409770 0
Participating patients’ opinions on the approach as well as a barriers and facilitators to root caries management strategies program uptake will be collected via a semi-structured interview designed specifically for this study, with a member of the research team.
Timepoint [2] 409770 0
12 months post-treatment commencement

Eligibility
Key inclusion criteria
- Be 55 or more years of age
- Have the capacity to make informed consent to participate or have a medical guardian who provides consent for patient to participate
- Have one or more active root caries lesions not involving the pulp
- Have at least 2 natural teeth that are functional
- Are not highly dependent on medical care
Minimum age
55 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients meeting any of the following criteria will be excluded from the study:
* For any reason is unable to provide informed consent
* Tooth with Grade 3 or more tooth mobility
* Is edentulous (no natural teeth) or has less than 10 teeth that are functional
* Has a history of rampant caries
* Has a history of allergy/intolerance to Silver or KI products
* Non-Carious Lesions with no active signs of caries or arrested caries

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/05/2025
Actual
Date of last participant enrolment
Anticipated
30/05/2025
Actual
Date of last data collection
Anticipated
30/05/2025
Actual
Sample size
Target
375
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 311466 0
Hospital
Name [1] 311466 0
Monash Health
Country [1] 311466 0
Australia
Primary sponsor type
Hospital
Name
Monash Health
Address
122 Thomas Street
Dandenong, VIC 3175
Country
Australia
Secondary sponsor category [1] 312866 0
None
Name [1] 312866 0
Address [1] 312866 0
Country [1] 312866 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 310935 0
Monash Health
Ethics committee address [1] 310935 0
Ethics committee country [1] 310935 0
Australia
Date submitted for ethics approval [1] 310935 0
25/05/2022
Approval date [1] 310935 0
Ethics approval number [1] 310935 0

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

Contacts
Principal investigator
Name 119410 0
Prof Rodrigo Mariño
Address 119410 0
Dental Services Monash Health 122 Thomas Street, Dandenong, VIC 3175
Country 119410 0
Australia
Phone 119410 0
+61 437808554
Fax 119410 0
Email 119410 0
[email protected]
Contact person for public queries
Name 119411 0
Parul Marwaha
Address 119411 0
Dental Services Monash Health 122 Thomas Street, Dandenong, VIC 3175
Country 119411 0
Australia
Phone 119411 0
+61 3 9792 7963
Fax 119411 0
Email 119411 0
[email protected]
Contact person for scientific queries
Name 119412 0
Parul Marwaha
Address 119412 0
Dental Services Monash Health 122 Thomas Street, Dandenong, VIC 3175
Country 119412 0
Australia
Phone 119412 0
+61 3 9792 7963
Fax 119412 0
Email 119412 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No



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.