Pilot and Feasibility Study of Impact of SDF 38% Application on Oral Health of Elderly With Autonomy Loss
NCT ID: NCT07194629
Last Updated: 2025-09-26
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
NOT_YET_RECRUITING
Clinical Phase
PHASE4
Total Enrollment
60 participants
Study Classification
INTERVENTIONAL
Study Start Date
2025-10-01
Study Completion Date
2026-12-31
Brief Summary
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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:
1. evaluate the relationship between SDF application and caries activity
2. Analysis of salivary biomarkers involved in the associated inflammatory processes.
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.
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:
1. evaluate the relationship between SDF application and caries activity
2. Analysis of salivary biomarkers involved in the associated inflammatory processes.
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.
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Detailed Description
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Conditions
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Dental Caries
Elderly
Loss of Autonomy
Silver Diamine Fluoride
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Parallel-group RCT with a delayed intervention for the control group
Primary Study Purpose
PREVENTION
Blinding Strategy
DOUBLE
Participants
Outcome Assessors
The statistician will be masked as well. The expert calibrating the dentists will also be masked
Study Groups
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Intervention
This arm will be provided with the intervention
Group Type
EXPERIMENTAL
Silver diamine Fluoride 38%
Intervention Type
DRUG
SDF 38%, applied on tooth surface for arrestation of active carious lesions and prevention of development of new carious lesions
Control
For ethical reasons the control arm will receive treatment after the first phase of data analysis
Group Type
PLACEBO_COMPARATOR
placebo solution
Intervention Type
DRUG
bluish liquid designed to mimic the appearance of SDF 38%
Interventions
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Silver diamine Fluoride 38%
SDF 38%, applied on tooth surface for arrestation of active carious lesions and prevention of development of new carious lesions
Intervention Type
DRUG
placebo solution
bluish liquid designed to mimic the appearance of SDF 38%
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
* Elderly of 65 years of age or older living at a long-term care facility targeted by the study.
* Should present at least one coronal or radicular active carious lesion that is asymptomatic, untreated, or a residual lesion under a restoration, and without pulp involvement.
* Should present at least one coronal or radicular active carious lesion that is asymptomatic, untreated, or a residual lesion under a restoration, and without pulp involvement.
Exclusion Criteria
* Participants with inadequate collaboration that may impede dental examination or treatment.
* Participants with cardiac valve prostheses, a history of bacterial endocarditis, or valve disease following a heart transplant.
* Completely edentulous elderly, as well as elderly presenting with no coronal or radicular caries
* Participants allergic to silver, fluoride or ammonia.
* Participants with cardiac valve prostheses, a history of bacterial endocarditis, or valve disease following a heart transplant.
* Completely edentulous elderly, as well as elderly presenting with no coronal or radicular caries
* Participants allergic to silver, fluoride or ammonia.
Minimum Eligible Age
65 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Université de Montréal
OTHER
Sponsor Role
lead
Responsible Party
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Nadia Gargouri
Assistant professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Locations
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Université de Montréal
Montreal, Quebec, Canada
Site Status
Institut universitaire de gériatrie de Montreal
Montreal, Quebec, Canada
Site Status
CHSLD Alfred Desrochers
Montreal, Quebec, Canada
Site Status
Countries
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Canada
Central Contacts
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Facility Contacts
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References
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Related Links
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Other Identifiers
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CER VN 25-26-11
Identifier Type: -
Identifier Source: org_study_id
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