Silver Diamine Fluoride and Gingivitis in Geriatric Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03445286|
Recruitment Status : Recruiting
First Posted : February 26, 2018
Last Update Posted : April 11, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Gingivitis||Device: Silver Diamine Fluoride Other: Normal Saline||Not Applicable|
- 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.
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||112 participants|
|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:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Masking Description:||The participants, care provider and outcome Assessor will be blinded The participants will be blinded about which interventions they will receive and the Outcomes Assessor who will evaluate the gingival condition will be blinded about the interventions, and also the care provider who will apply the intervention will be blinded|
|Official Title:||Effect of Silver Diamine Fluoride on the Treatment of Gingivitis in Geriatric Patients|
|Actual Study Start Date :||January 29, 2019|
|Estimated Primary Completion Date :||May 2020|
|Estimated Study Completion Date :||June 2020|
Experimental: Silver Diamine Fluordie Application
This group will receive Silver Diamine Fluoride (SDF) application once every week within three weeks period
Device: Silver Diamine Fluoride
Silver Diamine Fluoride (Advantage Arrest) for the experimental group
Other Name: Advantage Arrest
Placebo Comparator: Normal Saline
This control group will receive normal saline application once a week within a a three-week period
Other: Normal Saline
Normal Saline for the control group
- The change in Gingival Index GI (for Gingival Inflammation) [ Time Frame: Assessment of the change from the baseline at 2 weeks and 4 weeks after the final application of either Silver Diamine Fluoride or Chlorhexidine ]The change in Gingival Index GI (for Gingival Inflammation) from Baseline before the application of either Silver Diamine Fluoride or Chlorhexidine and at two weeks and four weeks after the final application of either Silver Diamine Fluoride or Chlorhexidine
- The change in Plaque Index PI (for dental plaque accumulation) [ Time Frame: Assessment of the change from the baseline at 2 weeks and 4 weeks after the final application of either Silver Diamine Fluoride or Chlorhexidine ]The change in Plaque Index PI (for dental plaque accumulation) from baseline before the application of either Silver Diamine Fluoride or Chlorhexidine and at two weeks and four weeks after the final application of either Silver Diamine Fluoride or Chlorhexidine
- Assessment of microbial counts in Dental Plaque [ Time Frame: Three times evaluation at baseline before the application of the intervention, then at 2 weeks and 4 weeks after the final application of either Silver Diamine Fluoride or Chlorhexidine ]Dental Plaque sample taken from each participant, labeled and send to the lab for analysis of bacterial counts (using Ubiome dental kit)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03445286
|Contact: AMAL NOURELDIN, BDS, MS, PhD||214-828-8354||AElemail@example.com|
|United States, Texas|
|Notre Dame Court (Seniors Independent Living)||Recruiting|
|Dallas, Texas, United States, 75208|
|Contact: Carmen Arana Property Manager 214-942-8000 firstname.lastname@example.org|
|Dickinson Place (Seniors Independent Living)||Recruiting|
|Dallas, Texas, United States, 75246|
|Contact: Jenny Brown, BSN, PSC 214-821-5390 email@example.com|
|Study Director:||WEDAD ALSHEHRI, BSDH, MS.||Texas A&M University College of Dentistry|