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
26/07/2022
Date data sharing statement initially provided
26/07/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Testing root caries arrest through two silver fluoride solutions: an efficacy trial in public oral health care settings in a population of older adults
Scientific title
Testing root caries arrest through two silver fluoride solutions: an efficacy trial in public oral health care settings in a population of older adults
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 trial will compare the effectiveness of two silver diamine fluoride (SDF) solutions:
a. Group 1 - SDI Riva Star Step 1 (SDF)
b. Group 2 - SDI Riva Star Aqua Step 1 (AgF)
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.
Silver and fluoride are recognised antimicrobial agents which is the active ingredient in both Riva. Riva Star is Ammonia based and Riva Star Aqua is a water-based silver fluoride product.
application time takes 10 seconds per application.
Follow-up will last for 12 months from baseline.
All participants will undergo a standardized oral examination that will be conducted by qualified, trained and calibrated oral health professionals (e.g. registered oral health therapist; and registered dentist). Examinations will take approximately 20 minutes, using standardized criteria defined for oral epidemiological studies.

SDF solutions are applied with a micro-brush to cover the decayed area. Once SDF is applied, SDF will stay there. Patients do not need to anything extra.

Two sites will be selected out of 7, to participate in this study. One site will use SDI Riva Star and the other site will use Riva Star Aqua Step 1 (AgF). These sites will be the two larges sites at Monash Health (i.e., Dandenong and Cranbourne).

To monitor adherence to the intervention will be assess by appointment attendance recorded in Titanium dental software.
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] 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 [1] 409770 0
12 months post-treatment commencement
Secondary outcome [2] 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 [2] 412036 0
6 months and 12 months post-treatment commencement

Eligibility
Key inclusion criteria
Independent living adult participants:
* Be 55 or more years of age
* Have the capacity to make informed consent to participate
* Be of good general health
* Have one or more active root caries lesions not involving the pulp
* Have at least 10 natural teeth that are functional
* Are not highly dependent on medical care and/or multiple medications or medication/s that affects the salivary flow.
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
* Has been diagnosed with a significant disease requiring regular treatment e.g., chemotherapy or radiotherapy, or is immune-suppressed due to illness
* 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
15/09/2022
Actual
Date of last participant enrolment
Anticipated
14/12/2022
Actual
Date of last data collection
Anticipated
31/12/2023
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
246 Clayton Rd
Research Support Services
Level 2, I Block
Monash Medical Centre
Clayton Victoria 3168
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
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 two silver diamine fluoride (SDF) solutions 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.
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
rodrigo.marino@monashhealth.org
Contact person for public queries
Name 119411 0
Dr 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
parul.marwaha@monashhealth.org
Contact person for scientific queries
Name 119412 0
Dr 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
parul.marwaha@monashhealth.org

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.