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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат Silver diamine Fluoride 38%
  SDF 38%, applied on tooth surface for arrestation of active carious lesions and prevention of development of new carious lesions
• Препарат placebo solution
  bluish liquid designed to mimic the appearance of SDF 38%

Первичные конечные точки

• Arrestation of active dental caries [Срок оценки: 0 (baseline)- 6 months (T1)- 12 months (T2)]

Вторичные конечные точки (3)

• Salivary biomarkers [Срок оценки: 0 (baseline)- 6 months (T1)- 12 months (T2)]
• Appreciation of participant [Срок оценки: 12 months(T2)]
• Sample size estimation [Срок оценки: 12 months(T2)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Профилактика

Центры проведения

Канада · 3 центра

• Université de Montréal — Montreal
• Institut universitaire de gériatrie de Montreal — Montreal
• CHSLD Alfred Desrochers — Montreal

Публикации

• 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. PMID 22390504
• AlQranei 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. PMID 33236462
• Gugnani 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. PMID 27672245
• Li 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. PMID 27208876
• Siqueira 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. PMID 30517634
• Featherstone 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. PMID 29355423
• Horst JA. Silver Fluoride as a Treatment for Dental Caries. Adv Dent Res. 2018 Feb;29(1):135-140. doi: 10.1177/0022034517743750. PMID 29355428

Идентификаторы

NCT: NCT07194629 · CER VN 25-26-11

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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