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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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | This arm will be provided with the intervention |
|
| Control | Placebo Comparator | For ethical reasons the control arm will receive treatment after the first phase of data analysis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
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) |
| Measure | Description | Time Frame |
|---|---|---|
| Salivary biomarkers | Salivary biomarkers involved in remineralization of enamel and tertiary dentin and the associated inflammatory processes | 0 (baseline)- 6 months (T1)- 12 months (T2) |
| Appreciation of participant |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nadia Gargouri, Assistant professor | Contact | (514) 343-6111 | 45960 | nadia.gargouri@umontreal.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Université de Montréal | Montreal | Quebec | H3T1J4 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Sophie DOMÉJEAN , D.M., Lucas VAN DER SLUIS, Nicolas DECERLE, John DB FEATHERSTONE, Évaluation CAMBRA du risque carieux : version française. editionscdp.fr, 2012. 04 | ||
| 22390504 | Background | 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. | |
| 33236462 |
| Label | URL |
|---|---|
| Related Info | View source |
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Parallel-group RCT with a delayed intervention for the control group
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The statistician will be masked as well. The expert calibrating the dentists will also be masked
| placebo solution | Drug | bluish liquid designed to mimic the appearance of SDF 38% |
|
Elderly and their representatives' appreciation of participation in the study evaluated by questionnaire
| 12 months(T2) |
| Sample size estimation | Sample size estimation for a future study | 12 months(T2) |
| Institut universitaire de gériatrie de Montreal | Montreal | Quebec | H3W1W5 | Canada |
|
| CHSLD Alfred Desrochers | Montreal | Quebec | H3W2P2 | Canada |
|
| Background |
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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