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Trial registered on ANZCTR


Registration number
ACTRN12625000072415
Ethics application status
Approved
Date submitted
25/11/2024
Date registered
23/01/2025
Date last updated
23/01/2025
Date data sharing statement initially provided
23/01/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Cluster randomized controlled trial of silver fluoride for oral health and wellbeing in aged care residents
Scientific title
Cluster randomized controlled trial of silver fluoride for oral health and wellbeing in aged care residents
Secondary ID [1] 312819 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Oral Health and Wellbeing 334903 0
Dental Decay 334904 0
Condition category
Condition code
Mental Health 331449 331449 0 0
Other mental health disorders
Oral and Gastrointestinal 331450 331450 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Public Health 331451 331451 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention package consists of two components:
1) Training residential aged care facility (RACF) staff in using an oral health assessment tool, and to assess their accuracy in identifying oral diseases, and
2) The use of 38% aqueous silver fluoride in arresting caries and thus reducing new tooth decay, tooth hypersensitivity and improvement in oral health-related quality of life.

Staff at the RACF will receive training in administering the M-OHAT at T0 (baseline).
a) Training will be provided by the research team consisting of dental professionals who are specialists in special needs dentistry and experienced in the older adult population.
b) Training will involve lecture (online or in-person pending logistics of each RACF), hands on practical training workshop, assessment and post participation survey. This training package is 4 hours in total and will occur within the week before the intervention package. There may be some incidences where the lecture component of training occurring >2 weeks prior to intervention package due to RACF and staff availability and location (rural). When this occurs, the lecture component will be online.

Training fidelity measures
Training will be undertaken by RACF staff at the participating sites. Trainees will complete a brief competency assessment (i.e., multiple choice test) following completion of the training. Completion rates will be monitored by the research team. Staff who do not complete the full training will not undertake the oral health assessments as part of the RCT.

Participants will receive a non-invasive oral health assessment by a RACF staff member and dental clinician. Both of whom has been trained by the research team. Research team and staff will conduct data collection following a Complications and Action Plan and a Distress Protocol.

All residents who provide consent, or have consent provided on their behalf and can provide assent will be invited in the following assessments:

Participants in the intervention group will receive a baseline assessment of their oral health and wellbeing plus the intervention at T1, and a 3-month follow-up oral health and wellbeing assessment at T2. The control group will receive the baseline (T1) assessment, serve out a no-intervention waitlist period, then receive the 3-month follow-up oral health and wellbeing assessment plus intervention package at T2.

The duration of the Modified - Oral Health Assessment Tool (M-OHAT) and comprehensive dental examination will be 30-40 minutes depending on participant compliance and complexity of oral conditions. The subsequent AgF intervention will take approximately 10 minutes, depending on how many teeth and level of participant compliance. Ideally, the M-OHAT/ comprehensive dental examination will be done in one session. However, depending on participant compliance and fatigue levels, this may be split into two sessions that is no more than 1 week apart.

1. M-OHAT assessment conducted by RACF staff
The M-OHAT is used by RACF staff to assess oral health in older adults. M-OHAT evaluates aspects of oral health, including natural teeth, oral cleanliness, dentures, lips, and oral mucosa. Each item is assessed using non-invasive dental examination techniques and is based on specific criteria, with higher scores indicating poorer oral health. The use of the M-OHAT tool allows for standardised oral health assessment ensuring consistency across different assessors and facilities. Additionally, M-OHAT measures can be used to track changes over time and evaluate the effectiveness of oral hygiene care provided by RACF staff or dental treatment by dental professionals (through referral and/or silver fluoride treatment). Staff will receive training prior to conducting M-OHAT assessment by member of research team who is a dental specialist in special needs dentistry and experienced in the area of older adult population.

2. A standardised oral epidemiological examination to be held at the facility.
The protocols for data collection will be based on the methodologies from the National Study of Adult Oral Health (NSAOH). The research team will train two or three specialised teams consisting of clinicians and data recorders. These teams will be trained in clinical assessment and the application of silver fluoride treatment. Training and calibration of clinicians will be conducted by the same trainers to ensure high-quality data collection and comparability across all assessments.
During the oral examination by dental clinician, the following data will be collected:
• Removable denture assessment.
• Assessment of oral mucosal tissues.
• Periodontal status including:
- Plaque, calculus, and gingivitis
- Tooth mobility: Grade I, II or III, based on established clinical standards.
• Tooth status, detailing whether teeth are present, absent, root stumps, crowns and bridges.
• Assessment of coronal and root caries, non-carious cervical lesions, and existing restorations.
• Tooth sensitivity.

After the oral health assessment, participants with suspected oral mucosal lesions, symptomatic teeth causing acute pain, abscess, and/or draining sinus, a recommendation will be made to participants/carers and residential facility about potential referral and treatment required, and the level of urgency. The procedure will follow the triaging protocol. The triage matrix below will provide prognosis of participants’ oral health in short term. Any participant in the control group who had cavitated lesion and has been predicted to have high risk for rapid caries progression would be recommended for urgent referral.

3. Silver fluoride intervention

Silver fluoride (AgF) is a topically applied solution that is used clinically to manage active dental caries, to arrest the condition and prevent further progression of disease as well as in the reduction of dentine hypersensitivity.

Silver fluoride application protocol
step 1 Introductions to qualified oral health professional (research team) who will carry out the treatment review
step 2 Surface of teeth to be cleaned, clinical assessment of caries status of teeth and clinical photographs taken.
step 3 Implement silver fluoride protocol. One time application of 38% aqueous silver fluoride will be undertaken to the selected teeth with a micro brush by a dental professional.
step 4 Ascertain if the participant had any adverse effects from the intervention, development of symptoms and any other changes
step 5 Treatment data will be entered directly into a computer using a specially designed data entry program and stored as computer data files. Data will be collected based on the data management protocol.
To ensure correct selection of appropriate teeth with caries for intervention package, dental professionals who have been trained by the research team will undertake the oral examination, selection of teeth and application of the silver fluoride and review at 3-months.
Intervention code [1] 329360 0
Treatment: Other
Comparator / control treatment
The control group will receive delayed intervention at 3 months (T2).
Control group
Active

Outcomes
Primary outcome [1] 339201 0
Caries development and arrest of dental caries assessed as a composite outcome
Timepoint [1] 339201 0
Baseline and 3 months follow up
Primary outcome [2] 339202 0
Tooth pain and sensitivity as a composite outcome
Timepoint [2] 339202 0
Baseline and 3 months follow up
Primary outcome [3] 340171 0
Effectiveness of M-OHAT when used by non-dental professionals to identify changes to oral conditions and the need to refer to dental professionals, as well as on the number of dental appointments booked where appropriate. This is a composite primary outcome.
Timepoint [3] 340171 0
Assessment will occur at both Baseline and 3 month follow up
Secondary outcome [1] 439063 0
Residential aged care residents’ oral health-related quality of life. This is a composite secondary outcome.
Timepoint [1] 439063 0
Baseline and 3 months follow up
Secondary outcome [2] 443119 0
Residential aged care residents’ general quality of life
Timepoint [2] 443119 0
Baseline and 3 months follow up
Secondary outcome [3] 443124 0
The cost effectiveness and scalability of the intervention package
Timepoint [3] 443124 0
Baseline and 3 months follow up
Secondary outcome [4] 443134 0
M-OHAT training impact on RACF staff knowledge and perception of oral health. This is a composite secondary outcome.
Timepoint [4] 443134 0
Baseline and 3 months follow up
Secondary outcome [5] 443169 0
RACF Resident participant experience on the M-OHAT
Timepoint [5] 443169 0
At the end of baseline appointment.

Eligibility
Key inclusion criteria
55 years old and over for those identifying as Aboriginal and/or Torres Strait Islanders
65 years olds and over for all other residents
Reside permanently in a participating RACF
Tentatively identified by RACF staff as potential participants
For those with capacity for consent, PICF will be provided and signed
For those without capacity for consent, QCAT approval has been obtained for this study. The participant’s next of kin would also be contacted if available.
Functionality eligibility – derived from ADL records & RACF staff
Physical eligibility – medical records & RACF staff
Minimum age
55 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Residents who are not able to participate
Residents who are disengaged (i.e., end of life)
Residents who are not interested in participating
Residents who are edentulous (i.e., have no natural teeth)

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)
This is a cluster randomised controlled trial by site. Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using computerised random number generation 1 or 2:
- 1 = intervention facility
- 2 = control facility (lagged treatment design at follow up)

Randomisation will occur at the cluster level (i.e., facilities), such that facilities will be randomised into intervention or control groups, and all participating residents at each facility will be allocated into the same group. A lagged treatment design with follow-ups will ensure that all participants to receive access to the oral health intervention package by the end of the study.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Delayed intervention
Phase
Not Applicable
Type of endpoint/s
Safety/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
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 317257 0
Government body
Name [1] 317257 0
National Health and Medical Research Council (NHMRC) - Medical Research Future Fund (MRFF)
Country [1] 317257 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
Country
Australia
Secondary sponsor category [1] 320237 0
None
Name [1] 320237 0
Address [1] 320237 0
Country [1] 320237 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315993 0
Darling Downs Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 315993 0
Ethics committee country [1] 315993 0
Australia
Date submitted for ethics approval [1] 315993 0
27/08/2024
Approval date [1] 315993 0
15/10/2024
Ethics approval number [1] 315993 0
HREC/2024/QTDD/105739

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

Contacts
Principal investigator
Name 136442 0
Prof Loc Do
Address 136442 0
The University of Queensland. School of Dentistry, 288 Herston Road, Herston. Queensland 4006
Country 136442 0
Australia
Phone 136442 0
+61 7 3346 4828
Fax 136442 0
Email 136442 0
[email protected]
Contact person for public queries
Name 136443 0
Loc Do
Address 136443 0
The University of Queensland. School of Dentistry, 288 Herston Road, Herston. Queensland 4006
Country 136443 0
Australia
Phone 136443 0
+61 7 3346 4828
Fax 136443 0
Email 136443 0
[email protected]
Contact person for scientific queries
Name 136444 0
Loc Do
Address 136444 0
The University of Queensland. School of Dentistry, 288 Herston Road, Herston. Queensland 4006
Country 136444 0
Australia
Phone 136444 0
+61 7 3346 4828
Fax 136444 0
Email 136444 0
[email protected]

Data sharing statement
Will there be any conditions when requesting access to individual participant data?
No
-

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.