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

• Sponsor: Heba Mitwalli
• Collaborator: The Forsyth Institute
• Information provided by (Responsible Party): Heba Mitwalli, University of Michigan

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Caries	Device: Silver Diamine Fluoride (SDF)	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 21 participants
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Effect of Silver Diamine Fluoride (SDF) on Bacteria Involved in Root or Cervical Carious Lesions Using HOMINGS Technology. A Clinical Study
• Study Start Date: November 2016
• Actual Primary Completion Date: April 20, 2017
• Actual Study Completion Date: April 20, 2017

Arms and Interventions

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 Name: Silver Dental Arrest

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.

Secondary Outcome Measures :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

United States, Michigan

University of Michigan School of Dentistry

Ann Arbor, Michigan, United States, 48109

Sponsors and Collaborators

Heba Mitwalli

The Forsyth Institute

Investigators

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

  Study Documents (Full-Text)

Documents provided by Heba Mitwalli, University of Michigan:

Study Protocol and Statistical Analysis Plan  [PDF] November 11, 2016

More Information

• Responsible Party: Heba Mitwalli, DDS, Master's Student, University of Michigan
• ClinicalTrials.gov Identifier: NCT02953886 History of Changes
• Other Study ID Numbers: HUM00117560
• First Posted: November 3, 2016
• Results First Posted: June 25, 2018
• Last Update Posted: September 28, 2018
• Last Verified: September 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: No

Keywords provided by Heba Mitwalli, University of Michigan:

Caries; Cavity; Silver Diamine Fluoride (SDF); HOMINGS

Additional relevant MeSH terms:

Dental Caries; Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Fluorides; Cariostatic Agents; Protective Agents; Physiological Effects of Drugs