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Silver Diamine Fluoride and Gingivitis in Geriatric Patients

NCT03445286 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2020-10-08

No results posted yet for this study

Summary

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.

Conditions

  • Gingivitis

Interventions

DEVICE

Silver Diamine Fluoride

Silver Diamine Fluoride (Advantage Arrest) for the experimental group

OTHER

Normal Saline

Normal Saline for the control group

Sponsors & Collaborators

  • Texas A & M University Baylor College Of Dentistry

    lead OTHER

Principal Investigators

  • WEDAD ALSHEHRI, BSDH, MS. · Texas A&M University College of Dentistry

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-01-29
Primary Completion
2020-01-10
Completion
2020-05-22
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03445286 on ClinicalTrials.gov