A Phase 4 interventional study of Silver diamine Fluoride 38% and placebo solution in Dental Caries, Elderly and Loss of Autonomy, sponsored by Université de Montréal. Not yet recruiting at 3 sites in Canada. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2025-09-26.
Sponsored by Université de Montréal · Phase 4, Interventional, and Prevention
Introduction: Dental caries constitutes a major oral health problem at a global scale for the elderly population. It impacts the health system due to its high incidence and prevalence and its associated costs. The growing population of elderly experiencing a loss of autonomy is accompanied by a decline in motor functions, which affects their ability to carry out everyday tasks such as brushing their teeth. The resulting poor oral hygiene can contribute to the onset of oral diseases. Dental caries can significantly impact the quality of life of the elderly by provoking pain, chewing difficulties, tooth loss and malnutrition. Recently, Silver Diamine Fluoride (SDF) 38% has been introduced to the market as an efficient solution for promoting oral health and arresting active caries. SDF is a compound of silver, fluoride, and ammonia, which comes in the form of a bluish liquid and is applied in small amounts on active carious lesions. Despite its recent approval by Health Canada as a temporary solution for arresting active caries, few randomized controlled trials have evaluated its effectiveness on the institutionalized elderly.
Objectives: This pilot study aims to evaluate the impact of SDF on the oral health of the elderly living in long-term care facilities.
Principal objective: evaluate effectiveness of SDF on arrestation of active caries when applied for the elderly with loss of autonomy in long-term care facilities.
Secondary objectives:
Methodology: A randomized controlled feasibility and effectiveness study design will be employed. This study will span over 12 months and will include 3 data collection phases.
At T0 (baseline): SDF group participants will receive an SDF application on their active caries. Control group participants will receive a 0.9% saline solution (placebo) application.
AT T1, 6 months after T0: First phase of data collection, the two groups will receive SDF application.
At T2, 12 months after T0: second phase of data collection, and for ethical reasons, the control group, who received placebo at T0, will receive an SDF application.
At the end of the project, a fluoride varnish application will be carried out on both groups to prolong preventive effects of treatment. A short questionnaire will also be shared with participants to evaluate their satisfaction and identify unintended adverse effects.
Anticipated results:
Demonstrate the efficiency of SDF in controlling active caries in the elderly with autonomy loss.
Elaborate a clinical protocol for SDF application in long-term care facilities Establish the required sample size for a future bigger study.
1,171 studies on the registry are indexed under Dental Caries; 209 are open to participants now.
This study's planned enrollment of 60 is close to the median of 60 across 967 interventional studies indexed under Dental Caries.
Browse Dental Caries studies →Université de Montréal is the lead sponsor of 98 studies on the registry; 11 are open to participants now.
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Exclusion Criteria:
This arm will be provided with the intervention
Drug: Silver diamine Fluoride 38%
For ethical reasons the control arm will receive treatment after the first phase of data analysis
Drug: placebo solution
SDF 38%, applied on tooth surface for arrestation of active carious lesions and prevention of development of new carious lesions
bluish liquid designed to mimic the appearance of SDF 38%
Arrestation of active dental caries
Evaluate the association between SDF 38% application and caries activity which will be measured at the end of the study by: 1. Number of active carious lesions Description: Count of clinically active coronal or radicular carious lesions. Unit of measure: Number of lesions per participant. Measurement tool: Visual-tactile clinical examination using ICDAS II criteria. 2. Number of carious lesions arrested by remineralization Description: Count of previously active lesions that present clinical signs of arrest (hard, shiny surface, absence of progression). Unit of measure: Number of arrested lesions per participant. Measurement tool: Visual-tactile clinical examination using ICDAS II criteria. 3. Number of reactivated carious lesions (where applicable) Description: Count of previously arrested lesions that show new signs of activity. Unit of measure: Number of reactivated lesions per participant. Measurement tool: Visual-tactile clinical examination using ICDAS II criteria.
Time frame: 0 (baseline)- 6 months (T1)- 12 months (T2)
Salivary biomarkers
Salivary biomarkers involved in remineralization of enamel and tertiary dentin and the associated inflammatory processes
Time frame: 0 (baseline)- 6 months (T1)- 12 months (T2)
Appreciation of participant
Elderly and their representatives' appreciation of participation in the study evaluated by questionnaire
Time frame: 12 months(T2)
Sample size estimation
Sample size estimation for a future study
Time frame: 12 months(T2)
Plan to share: No
Start is estimated for Oct 2025; primary completion for Nov 2026, 13 months later.
Of 25 phase 4 interventional studies under Dental Caries, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 31. This study's planned 13 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Silver diamine fluoride
Université de Montréal