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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02953886
Recruitment Status : Completed
First Posted : November 3, 2016
Results First Posted : June 25, 2018
Last Update Posted : September 28, 2018
Sponsor:
Collaborator:
The Forsyth Institute
Information provided by (Responsible Party):
Heba Mitwalli, University of Michigan

Study Description
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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
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tooth Decay

Arms and Interventions
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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
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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
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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
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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): NCT02953886


Locations
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United States, Michigan
University of Michigan School of Dentistry
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
Heba Mitwalli
The Forsyth Institute
Investigators
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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
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Responsible Party: Heba Mitwalli, DDS, Master's Student, University of Michigan
ClinicalTrials.gov Identifier: NCT02953886    
Other Study ID Numbers: HUM00117560
First Posted: November 3, 2016    Key Record Dates
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

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Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Heba Mitwalli, University of Michigan:
Caries
Cavity
Silver Diamine Fluoride (SDF)
HOMINGS
Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
 Fluorides
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs