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Cluster randomized controlled trial of silver fluoride for oral health and wellbeing in aged care residents

Cluster randomized controlled trial of silver fluoride for oral health and wellbeing in aged care residents

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12625000072415
Enrollment
1120
Registered
2025-01-23
Start date
2025-03-03
Completion date
Unknown
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

This multi-disciplinary project aims to improve oral health access, assessment, and treatment for older adults in rural and regional Residential Aged Care Facilities (RACFs) through three key activities: 1. Pre-trial training/upskilling of non-dental staff at a network of regional and rural RACFs to assess residents' oral health using a modified oral health assessment tool (M-OHAT) and treatment referral system, currently under development via co-design. 2. A cluster randomised controlled trial to test the effectiveness of an intervention (application of silver fluoride to specific dental lesions) in improving oral health and wellbeing in approximately 1000 eligible residents at participating RACFs. 3.An economic evaluation of the cost effectiveness and potential scalability of the silver fluoride intervention. The primary project outcomes are residents’ oral health (reduction in caries development, arrest of dental caries, and reduction in tooth pain and sensitivity), while secondary outcomes include residents’ oral health-related quality of life, general quality of life, and mental health and wellbeing. The project also aims to explore if M-OHAT training improves RACF staff knowledge and perception of oral health.

Interventions

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 p

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.

Sponsors

University of Queensland
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator)

Eligibility

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

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

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)

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026