Pilot and Feasibility Study of Impact of SDF 38% Application on Oral Health of Elderly With Autonomy Loss

NCT07194629 | Not Yet Recruiting Phase 4

• 1 other identifier: CER VN 25-26-11
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

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. 1.evaluate the relationship between SDF application and caries activity
2. 2.Analysis of salivary biomarkers involved in the associated inflammatory processes.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  0 (baseline)- 6 months (T1)- 12 months (T2)

Secondary Outcomes (3)

• Salivary biomarkers

  0 (baseline)- 6 months (T1)- 12 months (T2)

• Appreciation of participant

  12 months(T2)

• Sample size estimation

  12 months(T2)

Study Arms (2)

Intervention

EXPERIMENTAL

This arm will be provided with the intervention

Drug: Silver diamine Fluoride 38%

Control

PLACEBO COMPARATOR

For ethical reasons the control arm will receive treatment after the first phase of data analysis

Drug: placebo solution

Interventions

Silver diamine Fluoride 38% DRUG

SDF 38%, applied on tooth surface for arrestation of active carious lesions and prevention of development of new carious lesions

Intervention

placebo solution DRUG

bluish liquid designed to mimic the appearance of SDF 38%

Control

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Université de Montréal: lead

Study Sites (3)

Université de Montréal

Montreal, Quebec, H3T1J4, Canada

Location

Institut universitaire de gériatrie de Montreal

Montreal, Quebec, H3W1W5, Canada

Location

CHSLD Alfred Desrochers

Montreal, Quebec, H3W2P2, Canada

Location

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Related Links

• Related Info

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Central Study Contacts

Nadia Gargouri, Assistant professor

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The statistician will be masked as well. The expert calibrating the dentists will also be masked
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Model Details: Parallel-group RCT with a delayed intervention for the control group

Study Record Dates

• First Submitted: September 11, 2025
• First Posted: September 26, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): November 15, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)