Dental CariesPhase 4NCT07194629
Pilot and Feasibility Study of Impact of SDF 38% Application on Oral Health of Elderly With Autonomy Loss
A Phase 4 study testing Silver diamine Fluoride 38% in people with Dental Caries and Elderly, run by Université de Montréal at 3 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Dental Caries, Elderly, Loss of Autonomy
- What is being tested?
- Silver diamine Fluoride 38%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 3 sitesCanada
- Study dates
- 1 Oct 2025to 31 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada3 sites
Université de Montréal
Montreal, Quebec, H3T1J4
Nadia Gargouri, Assistant professor, (514) 343-6111 ext. 45960, nadia.gargouri@umontreal.ca
Institut universitaire de gériatrie de Montreal
Montreal, Quebec, H3W1W5
Nadia Gargouri, Assistant professor, (514) 343-6111 ext. 45960, nadia.gargouri@umontreal.ca
CHSLD Alfred Desrochers
Montreal, Quebec, H3W2P2
Nadia Gargouri, Assistant professor, (514) 343-6111 ext. 45960, nadia.gargouri@umontreal.ca
About this study
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
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.
Read more
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:
- evaluate the relationship between SDF application and caries activity
- 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.
- Conditions
- Dental Caries, Elderly, Loss of Autonomy, Silver Diamine Fluoride
- Being tested
- Silver diamine Fluoride 38%, placebo solution
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
placebo solutionDrug
bluish liquid designed to mimic the appearance of SDF 38%
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | This arm will be provided with the intervention Receives: Drug: Silver diamine Fluoride 38% |
| Control | Placebo comparator | For ethical reasons the control arm will receive treatment after the first phase of data analysis Receives: Drug: placebo solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- 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.
- 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.
- 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.
Measured: 0 (baseline)- 6 months (T1)- 12 months (T2)
Secondary outcomes (3)
Salivary biomarkers
Salivary biomarkers involved in remineralization of enamel and tertiary dentin and the associated inflammatory processes
Measured: 0 (baseline)- 6 months (T1)- 12 months (T2)
Appreciation of participant
Elderly and their representatives' appreciation of participation in the study evaluated by questionnaire
Measured: 12 months(T2)
Sample size estimation
Sample size estimation for a future study
Measured: 12 months(T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2025
- Study start1 Oct 2025 (estimated)
- Primary completion15 Nov 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (64)Papers the sponsor has linked to this study.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel-group RCT with a delayed intervention for the control group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Montréal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nadia Gargouri, Université de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07194629
- Sponsor's protocol ID
- CER VN 25-26-11
- Status last verified
- Sep 2025
- First submitted
- 11 Sep 2025
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sophie DOMÉJEAN , D.M., Lucas VAN DER SLUIS, Nicolas DECERLE, John DB FEATHERSTONE, Évaluation CAMBRA du risque carieux : version française. editionscdp.fr, 2012. 04
Griffin SO, Jones JA, Brunson D, Griffin PM, Bailey WD. Burden of oral disease among older adults and implications for public health priorities. Am J Public Health. 2012 Mar;102(3):411-8. doi: 10.2105/AJPH.2011.300362. Epub 2012 Jan 19.
PubMed 22390504AlQranei MS, Balhaddad AA, Melo MAS. The burden of root caries: Updated perspectives and advances on management strategies. Gerodontology. 2021 Jun;38(2):136-153. doi: 10.1111/ger.12511. Epub 2020 Nov 24.
PubMed 33236462Gugnani N, Pandit IK, Srivastava N, Gupta M, Sharma M. International Caries Detection and Assessment System (ICDAS): A New Concept. Int J Clin Pediatr Dent. 2011 May-Aug;4(2):93-100. doi: 10.5005/jp-journals-10005-1089. Epub 2010 Apr 15.
PubMed 27672245Li R, Lo EC, Liu BY, Wong MC, Chu CH. Randomized clinical trial on arresting dental root caries through silver diammine fluoride applications in community-dwelling elders. J Dent. 2016 Aug;51:15-20. doi: 10.1016/j.jdent.2016.05.005. Epub 2016 May 18.
PubMed 27208876Siqueira GSA, Hagemann PMS, Coelho DS, Santos FHD, Bertolucci PHF. Can MoCA and MMSE Be Interchangeable Cognitive Screening Tools? A Systematic Review. Gerontologist. 2019 Nov 16;59(6):e743-e763. doi: 10.1093/geront/gny126.
PubMed 30517634Featherstone JDB, Chaffee BW. The Evidence for Caries Management by Risk Assessment (CAMBRA(R)). Adv Dent Res. 2018 Feb;29(1):9-14. doi: 10.1177/0022034517736500.
PubMed 29355423Horst JA. Silver Fluoride as a Treatment for Dental Caries. Adv Dent Res. 2018 Feb;29(1):135-140. doi: 10.1177/0022034517743750.
PubMed 29355428Santé, O.m.d.l., Prévention et traitement des caries dentaires avec des produits sans mercure et une intervention minimale : Série de notes d'information de l'OMS sur la santé buccodentaire. 2022
Rosenblatt A, Stamford TC, Niederman R. Silver diamine fluoride: a caries "silver-fluoride bullet". J Dent Res. 2009 Feb;88(2):116-25. doi: 10.1177/0022034508329406.
PubMed 19278981Hobdell M, Petersen PE, Clarkson J, Johnson N. Global goals for oral health 2020. Int Dent J. 2003 Oct;53(5):285-8. doi: 10.1111/j.1875-595x.2003.tb00761.x. No abstract available.
PubMed 14560802Seifo N, Cassie H, Radford JR, Innes NPT. Silver diamine fluoride for managing carious lesions: an umbrella review. BMC Oral Health. 2019 Jul 12;19(1):145. doi: 10.1186/s12903-019-0830-5.
PubMed 31299955Worthington HV, Lewis SR, Glenny AM, Huang SS, Innes NP, O'Malley L, Riley P, Walsh T, Wong MCM, Clarkson JE, Veitz-Keenan A. Topical silver diamine fluoride (SDF) for preventing and managing dental caries in children and adults. Cochrane Database Syst Rev. 2024 Nov 7;11(11):CD012718. doi: 10.1002/14651858.CD012718.pub2.
PubMed 39508296Oliveira BH, Cunha-Cruz J, Rajendra A, Niederman R. Controlling caries in exposed root surfaces with silver diamine fluoride: A systematic review with meta-analysis. J Am Dent Assoc. 2018 Aug;149(8):671-679.e1. doi: 10.1016/j.adaj.2018.03.028. Epub 2018 May 24.
PubMed 29805039McReynolds D, Duane B. Systematic review finds that silver diamine fluoride is effective for both root caries prevention and arrest in older adults. Evid Based Dent. 2018 Jun;19(2):46-47. doi: 10.1038/sj.ebd.6401304.
PubMed 29930359
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07194629
- Acronym / sponsor ID
- CER VN 25-26-11
- Conditions
- Dental Caries, Elderly, Loss of Autonomy, Silver Diamine Fluoride
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Université de MontréalUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 15 Nov 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 26 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- evaluate the relationship between SDF application and caries activity
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel-group RCT with a delayed intervention for the control group
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: Silver diamine Fluoride 38%This arm will be provided with the intervention |
| Control | Placebo comparator | Drug: placebo solutionFor ethical reasons the control arm will receive treatment after the first phase of data analysis |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Silver diamine Fluoride 38%SDF 38%, applied on tooth surface for arrestation of active carious lesions and prevention of development of new carious lesions | Drug | Intervention |
| placebo solutionbluish liquid designed to mimic the appearance of SDF 38% | Drug | Control |
Primary outcome
Arrestation of active dental caries
Time frame: 0 (baseline)- 6 months (T1)- 12 months (T2)
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.
3 secondary outcomes
Salivary biomarkers
Time frame: 0 (baseline)- 6 months (T1)- 12 months (T2)
Appreciation of participant
Time frame: 12 months(T2)
Sample size estimation
Time frame: 12 months(T2)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
- BackgroundSophie DOMÉJEAN , D.M., Lucas VAN DER SLUIS, Nicolas DECERLE, John DB FEATHERSTONE, Évaluation CAMBRA du risque carieux : version française. editionscdp.fr, 2012. 04
- Background: PubMed 22390504Griffin SO, Jones JA, Brunson D, Griffin PM, Bailey WD. Burden of oral disease among older adults and implications for public health priorities. Am J Public Health. 2012 Mar;102(3):411-8. doi: 10.2105/AJPH.2011.300362. Epub 2012 Jan 19.
- Background: PubMed 33236462AlQranei MS, Balhaddad AA, Melo MAS. The burden of root caries: Updated perspectives and advances on management strategies. Gerodontology. 2021 Jun;38(2):136-153. doi: 10.1111/ger.12511. Epub 2020 Nov 24.
- Background: PubMed 27672245Gugnani N, Pandit IK, Srivastava N, Gupta M, Sharma M. International Caries Detection and Assessment System (ICDAS): A New Concept. Int J Clin Pediatr Dent. 2011 May-Aug;4(2):93-100. doi: 10.5005/jp-journals-10005-1089. Epub 2010 Apr 15.
- Background: PubMed 27208876Li R, Lo EC, Liu BY, Wong MC, Chu CH. Randomized clinical trial on arresting dental root caries through silver diammine fluoride applications in community-dwelling elders. J Dent. 2016 Aug;51:15-20. doi: 10.1016/j.jdent.2016.05.005. Epub 2016 May 18.
- Background: PubMed 30517634Siqueira GSA, Hagemann PMS, Coelho DS, Santos FHD, Bertolucci PHF. Can MoCA and MMSE Be Interchangeable Cognitive Screening Tools? A Systematic Review. Gerontologist. 2019 Nov 16;59(6):e743-e763. doi: 10.1093/geront/gny126.
- Background: PubMed 29355423Featherstone JDB, Chaffee BW. The Evidence for Caries Management by Risk Assessment (CAMBRA(R)). Adv Dent Res. 2018 Feb;29(1):9-14. doi: 10.1177/0022034517736500.
- Background: PubMed 29355428Horst JA. Silver Fluoride as a Treatment for Dental Caries. Adv Dent Res. 2018 Feb;29(1):135-140. doi: 10.1177/0022034517743750.
- BackgroundSanté, O.m.d.l., Prévention et traitement des caries dentaires avec des produits sans mercure et une intervention minimale : Série de notes d'information de l'OMS sur la santé buccodentaire. 2022
- Background: PubMed 19278981Rosenblatt A, Stamford TC, Niederman R. Silver diamine fluoride: a caries "silver-fluoride bullet". J Dent Res. 2009 Feb;88(2):116-25. doi: 10.1177/0022034508329406.
- Background: PubMed 14560802Hobdell M, Petersen PE, Clarkson J, Johnson N. Global goals for oral health 2020. Int Dent J. 2003 Oct;53(5):285-8. doi: 10.1111/j.1875-595x.2003.tb00761.x. No abstract available.
- Background: PubMed 31299955Seifo N, Cassie H, Radford JR, Innes NPT. Silver diamine fluoride for managing carious lesions: an umbrella review. BMC Oral Health. 2019 Jul 12;19(1):145. doi: 10.1186/s12903-019-0830-5.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Silver diamine Fluoride 38% in people with Dental Caries and Elderly, run by Université de Montréal at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nadia Gargouri, Assistant professor ((514) 343-6111 ext. 45960, nadia.gargouri@umontreal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arrestation of active dental caries (time frame: 0 (baseline)- 6 months (T1)- 12 months (T2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07194629, which also lists 64 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2025.