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Testing root caries arrest with silver diamine fluoride: an effectiveness trial in public oral health care settings

Testing root caries arrest with silver diamine fluoride: an effectiveness trial in public oral health care settings

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622001041741
Enrollment
375
Registered
2022-07-26
Start date
2025-05-30
Completion date
2025-05-30
Last updated
2025-09-08

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

Conditions

None listed

Brief summary

The ageing profile of the Australian population is well documented. The proportion of people aged 65 and over has been predicted to rapidly rise over the next few years. There is also evidence of an epidemiological transition in oral health, moving from high rates of edentulism and tooth loss towards lower rates of edentulism in the older population. Still, dental caries is one of the most significant health problems facing older adults. This creates new challenges to the society. One of these challenges is how to maintain the oral health of that group of the population. Preventive or therapy approaches are preferred to restorations. This is particularly the case for root caries lesions. In fact, prevention of root caries is central in older adults as they frequently have exposed root surfaces and may have compromised salivary flow. Further research is required into preventing root caries lesions. This study will compare the effectiveness of silver diamine fluoride (SDF) solution in arresting dental root caries and to assess the colour of arrested caries lesions at 12 months after 2 applications: baseline and 6 months in follow up dentine/root caries in older adults living in a fluoridated area.

Interventions

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.

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.

Sponsors

Monash Health
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
55 Years to No maximum
Healthy volunteers
No

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

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026