• Comparison of Silver Diamine Fluoride and Sodium Fluoride Varnish to Prevent and Arrest Root Caries in Older Adults

  NCT04432415

  SuspendedInterventionalNot ApplicableUpdated Jun 16, 2020
• Silver Diamine Fluoride Pilot Study (SDF)

  NCT02591147

  CompletedInterventionalNot ApplicableUpdated Mar 14, 2023
• Effectiveness on SDF Solution and PVP-I Combined NaF Varnish in Preventing Root Caries in Elders

  NCT03654820

  Unknown statusInterventionalNot ApplicableUpdated Sep 5, 2018
• High Fluoride and Root Caries in Older Adults (NIT-RCL-UTALCA)

  NCT06749275

  CompletedInterventionalNot ApplicableUpdated Dec 27, 2024
• Silver Diamine Fluoride and Gingivitis in Geriatric Patients

  NCT03445286

  CompletedInterventionalNot ApplicableUpdated Oct 8, 2020
• Managing Dentine Hypersensitivity With Silver Diamine Fluoride on Older Adults

  NCT05392868

  Unknown statusInterventionalPhase 2Updated Jul 25, 2023

ClinicalTrials.gov ID

NCT07194629

Lead Sponsor

Université de MontréalOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Phase 4

Enrollment

60Estimated

Last Update Posted

Sep 26, 2025Actual

Start Date

Oct 1, 2025Estimated

Primary Completion Date

Nov 15, 2026Estimated

Completion Date

Dec 31, 2026Estimated

Official Title

Impact of Silver Diamine Fluoride (SDF) 38% Application on the Oral Health of the Elderly With Loss of Autonomy Living in Long-term Care Homes (CHSLDs): A Pilot and Feasibility Effectiveness Study

Brief Summary

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.

• Dental Caries
• Elderly
• Loss of Autonomy
• Silver Diamine Fluoride

• Silver diamine Fluoride 38%
• placebo solution

Ages Eligible for Study

Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

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.

Primary Purpose

Prevention

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Double

Lead Sponsor

Université de MontréalOTHER

nadia.gargouri@umontreal.ca(514) 343-6111 ext. 45960