Silver Diamine Fluoride and Gingivitis in Geriatric Patients

Completed · Not applicable

Conditions studied: Gingivitis

In brief

Gingivitis in the geriatric population is one of the growing global public health concerns, thus finding the most effective and non-invasive approach to prevent and treat gingivitis in the geriatric population is essential to prevent tooth loss and maintain oral health and function. Silver Diamine Fluoride (SDF) is Class II medical device. It was cleared for use in US August 2014 and became commercially available in April 2015. It is a chemical agent which has bifunctional properties. The silver itself kills caries causing bacteria directly. Silver and fluoride together interact to form fluorapatite, in addition, assist in hardening the teeth and preventing further demineralization. Even though SDF has been approved in dental caries prevention and treatment, there are no published studies or evidence that evaluated the direct effect of SDF on gingivitis. If SDF improves or prevents gingivitis is unknown. The main goal of this clinical study is to investigate the effect of SDF on gingival status in geriatric patients with gingivitis. There is an urgent need to solve this common oral disease in the geriatric population. The logic for this research in a geriatric population is to find the most effective approach to treat gingivitis to prevent tooth loss and maintain oral health and function. To find an effective approach to treat gingivitis in the geriatric group, we will investigate the effectiveness of SDF application on gingival tissues in this group. The patients with gingivitis will be randomly allocated to two groups: group1(case group) will receive SDF application and group 2 (control group) will receive a normal saline application. The gingiva will be evaluated for both groups at baseline before the application. Then 2 weeks and 4 weeks after the last application of the intervention. In addition, a sample of plaque will be taken from the teeth selected in this study by swab using the dental kit (Ubiome) before and after both applications to quantify the presence of bacterial pathogen at baseline and follow up visits. The feasibility of this proposed therapy is supported by published literature that has shown that SDF was effective in dental and root caries prevention and treatment in geriatric patients.

Key facts

Study ID

NCT03445286

Run by

Texas A & M University Baylor College Of Dentistry

People needed

48

Starts

2019-01-29

Expected to finish

2020-05-22

Last updated by the study team

2020-10-08

Who can join

Age: 65 and older, up to 90. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age group 65 years and older
• Males and females
• Minimum of 6 remaining teeth with gingivitis (at least one posterior tooth should be present)
• Every participant should agree to not brush or floss three days prior the data collection
• Every participant should agree to not use any mouthwash or Fluoride treatment for the entire study period
• All socioeconomic status included

You may not qualify if…

• Active chemotherapy or radiotherapy
• Known history of allergy to Silver Particles
• Uncontrolled diabetes
• Use of antibiotics in the last three months
• Periodontal therapy in the last 3 months
• Mouth rinse such as Chlorhexidine (CHX) at least 30 days prior to the study
• Smoking
• Epileptic patients on medication cause gingival overgrowth
• Patients who are unable to give consent
• Teeth with periodontitis

Where it is running

• Notre Dame Court (Seniors Independent Living) — Dallas, Texas, United States
• Dickinson Place (Seniors Independent Living) — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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