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Silver Diamine Fluoride and Gingivitis in Geriatric Patients

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ClinicalTrials.gov Identifier: NCT03445286
Recruitment Status : Recruiting
First Posted : February 26, 2018
Last Update Posted : April 11, 2019
Sponsor:
Information provided by (Responsible Party):
Amal Noureldin, Texas A & M University Baylor College Of Dentistry

Brief 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.


Condition or disease Intervention/treatment Phase
Gingivitis Device: Silver Diamine Fluoride Other: Normal Saline Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 112 participants
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: 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
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 90 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

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


Contacts
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Contact: AMAL NOURELDIN, BDS, MS, PhD 214-828-8354 AEl-din@tamhsc.edu

Locations
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United States, Texas
Notre Dame Court (Seniors Independent Living) Recruiting
Dallas, Texas, United States, 75208
Contact: Carmen Arana Property Manager    214-942-8000    manager@notredamecourt.org   
Dickinson Place (Seniors Independent Living) Recruiting
Dallas, Texas, United States, 75246
Contact: Jenny Brown, BSN, PSC    214-821-5390    jennyb@dickinsonplace.org   
Sponsors and Collaborators
Texas A & M University Baylor College Of Dentistry
Investigators
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Study Director: WEDAD ALSHEHRI, BSDH, MS. Texas A&M University College of Dentistry

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Responsible Party: Amal Noureldin, Clinical Associate Professor, Texas A & M University Baylor College Of Dentistry
ClinicalTrials.gov Identifier: NCT03445286     History of Changes
Other Study ID Numbers: IRB2017-0917
First Posted: February 26, 2018    Key Record Dates
Last Update Posted: April 11, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Amal Noureldin, Texas A & M University Baylor College Of Dentistry:
Gingivitis and geriatric patients
Silver Diamine Fluoride and gingivitis
Sliver Diamine Fluoride

Additional relevant MeSH terms:
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Gingivitis
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Fluorides
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs