The Effect of Silver Diamine Fluoride (SDF) on Bacteria Involved in Root or Cervical Carious Lesions

September 27, 2018 updated by: Heba Mitwalli

The Effect of Silver Diamine Fluoride (SDF) on Bacteria Involved in Root or Cervical Carious Lesions Using HOMINGS Technology. A Clinical Study

The study will compare bacteria levels in cavities before and after silver diamine fluoride (SDF) treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

To assess the effect of silver diamine fluoride (SDF) treatment on microorganisms present in root caries or cervical lesions by collecting microbial deposits before and 1 month after SDF application. Bacterial samples will be collected from 20 adult subjects at the initial visit before application of SDF and one month after. At the 1 month recall, examination for caries arrest will be performed. All 40 bacterial samples will be sent to the Forsyth Institute to verify bacterial composition using HOMINGS technology.

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan School of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Generally healthy adult participants 18 years of age and older.
  • At least one tooth with active (soft) cavitated lesions of ICDAS score 5 or 6 near the gingival margin (coronal cervical caries at the CEJ or exposed root surfaces with soft active carious lesions exposing dentin).

Exclusion Criteria:

  • Adult participants who suffer from serious life-threatening medical diseases that interfere with basic daily self care activities.
  • Patients taking antibiotics within the last two weeks.
  • Patients using chlorhexidine or fluoride mouth washes within the last two weeks.
  • Pregnant or breastfeeding women.
  • Teeth with arrested (hard) cervical or root caries lesions.
  • Teeth that have been diagnosed with an abscess or an irreversible pulpitis, or are mobile.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Silver Diamine Fluoride (SDF)
Application of Silver Diamine Fluoride (SDF) to root or cervical carious lesions (cavities). Collection of plaque pre- and one month post-SDF application.
Device: Silver Diamine Fluoride (SDF)
No caries removal will take place. Bacterial samples will be collected using Gracey curettes at the initial visit before application of SDF and one month after. The tooth will be dried and SDF will be placed on the carious dentin until saturated. Excess will be blotted dry with a cotton pellet
Other Names:
  • Silver Dental Arrest

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Bacterial Composition Before and One Month After SDF Application to Root or Cervical Caries Lesions
Time Frame: baseline, One month after SDF
Using human oral microbiome identification using next-generation sequencing (HOMINGS), change in the total bacterial composition of all subjects was measured by the difference of the number of bacteria count from baseline to one month after SDF application.
baseline, One month after SDF
Caries Arrest of Teeth Measured by Change in Dentin Texture (Soft, Hard)
Time Frame: One month
Caries were examined for hardness or softness before and after SDF application. The change in the texture was examined after one month of SDF application the change from soft to hard is noted below.
One month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Assessment of Appearance of Treated Tooth (Concern With the Appearance of Study Tooth, Desire for the Study Tooth to be Filled)
Time Frame: One month
Each subject was asked if they were concerned with the appearance of the tooth that SDF was applied too. They were also asked if they wanted the study tooth to be filled with a tooth color filling.
One month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heba Mitwalli

Collaborators

The Forsyth Institute

Investigators

  • Principal Investigator: Heba Mitwalli, DDS, University of Michigan
  • Study Chair: Margherita Fontana, DDS, PhD, University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (Actual)

April 20, 2017

Study Completion (Actual)

April 20, 2017

Study Registration Dates

First Submitted

October 27, 2016

First Submitted That Met QC Criteria

November 2, 2016

First Posted (Estimate)

November 3, 2016

Study Record Updates

Last Update Posted (Actual)

September 28, 2018

Last Update Submitted That Met QC Criteria

September 27, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00117560

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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