Silver Diamine Fluoride and Gingivitis in Geriatric Patients

NCT03445286 | Completed FDA Device

• 1 other identifier: IRB2017-0917
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

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.

Conditions

Gingivitis

Keywords

Gingivitis and geriatric patients; Silver Diamine Fluoride and gingivitis; Sliver Diamine Fluoride

Outcome Measures

Primary Outcomes (2)

• The change in Gingival Index GI (for Gingival Inflammation)

  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

  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)

  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 the change from the baseline at 2 weeks and 4 weeks after the final application of either Silver Diamine Fluoride or Chlorhexidine

Secondary Outcomes (1)

• Assessment of microbial counts in Dental Plaque

  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

Study Arms (2)

Silver Diamine Fluordie Application

EXPERIMENTAL

This group will receive Silver Diamine Fluoride (SDF) application once every week within three weeks period

Device: Silver Diamine Fluoride

Normal Saline

PLACEBO COMPARATOR

This control group will receive normal saline application once a week within a a three-week period

Other: Normal Saline

Interventions

Silver Diamine Fluoride DEVICE

Silver Diamine Fluoride (Advantage Arrest) for the experimental group

Also known as: Advantage Arrest

Silver Diamine Fluordie Application

Normal Saline OTHER

Normal Saline for the control group

Normal Saline

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

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

Sponsors & Collaborators

• Texas A & M University Baylor College Of Dentistry: lead

Study Sites (2)

Notre Dame Court (Seniors Independent Living)

Dallas, Texas, 75208, United States

Location

Dickinson Place (Seniors Independent Living)

Dallas, Texas, 75246, United States

Location

Related Publications (1)

• Noureldin A, Alshehri W, Tapias H, Mallonee L, Mancl LM, Milgrom P, Svboda K. Efficacy of 38% silver diamine fluoride in reducing gingival inflammation and plaque accumulation in older adults living in retirement-homes: A randomized controlled pilot trial. J Dent. 2024 Apr;143:104890. doi: 10.1016/j.jdent.2024.104890. Epub 2024 Feb 20.

  PMID: 38387597 DERIVED

MeSH Terms

Conditions

Gingivitis

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• WEDAD ALSHEHRI, BSDH, MS.

  Texas A&M University College of Dentistry

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The participants 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Model Details: 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

Study Record Dates

• First Submitted: February 13, 2018
• First Posted: February 26, 2018
• Study Start: January 29, 2019
• Primary Completion: January 10, 2020
• Study Completion: May 22, 2020
• Last Updated: October 8, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)