Silver Diamine Fluoride and Gingivitis in Geriatric Patients
Condition: Gingivitis
MeSH terms: Gingivitis
Study type: Interventional

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.
    

Detailed description: 
      The Aims

        -  Aim 1 To investigate the effect of SDF application on gingival status in elder patients
           with gingivitis. To accomplish this aim, the subjects with gingivitis will be randomly
           allocated to two groups: group 1(case group) will receive SDF application and group 2
           (control group) will receive Normal Saline. The SDF and normal saline will apply on the
           selected teeth with gingivitis once a week during a three-week period. The gingival
           status will be evaluated at baseline before the application of either SDF or normal
           saline. Then at the second week and fourth week after the final application. The
           measurable outcomes will be Plaque Index (PI) and the Gingival Index (GI). In addition,
           record of existing brushing and flossing habits. If SDF application shows an improvement
           in the gingival condition (reduction in the plaque and gingival indices) in treatment
           group comparing to the control group it indicates that its effectiveness not only on
           dental caries as published, but it is also may extended to include gingivitis.

        -  Aim 2 To quantify the presence of bacterial pathogen in the dental biofilm. To
           accomplish this aim, a sample of dental plaque will be taken from the teeth selected in
           this study by swab using the dental kit (Ubiome) before and after the SDF or normal
           saline application to quantify the presence of bacterial pathogen at baseline before the
           application, 2 weeks and 4 weeks after the application.

      Summary:

      The proposed therapeutic intervention of Silver Diamine Fluoride (SDF) in treating geriatric
      patients with gingivitis will establish a new adjunctive and inexpensive protocol for
      treatment of gingivitis. Gingivitis is inflammation of gingival tissues caused by dental
      biofilm bacterial infection. Left untreated, gingivitis will cause tooth loss. The
      preliminary results will provide new recommendations for treating geriatric patients in a
      safe, effective, and low-cost manner. This study will also address the gap in scientific
      knowledge regarding the use of SDF to treat gingivitis in elderly patients.

      Research Hypothesis: The application of SDF varnish is expected to improve the gingival
      condition and can be an effective approach in the treatment of gingivitis in geriatric
      patients.

      Null Hypothesis: The application of SDF varnish does not improve the gingival condition and
      cannot be an effective approach in the treatment of gingivitis in geriatric patients.

      Research Question: Does the application of silver Diamine Fluoride on teeth with gingivitis
      will improve the gingival condition in geriatric patients with gingivitis
    

Intervention name(s): Silver Diamine Fluoride; Normal Saline
Intervention type(s): Device; Other
Intervention description(s): Silver Diamine Fluoride (Advantage Arrest) for the experimental group; Normal Saline for the control group
Other intervention name(s): Advantage Arrest
Intervention MeSH terms: Fluorides
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The participants with gingivitis are randomly allocated to two groups: group 1(case group) who will receive SDF application once every week within three weeks period and group 2 (control group) who will receive normal saline application once a week within three-week period
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Gingivitis and geriatric patients; Silver Diamine Fluoride and gingivitis; Sliver Diamine Fluoride