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

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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

Tracking Information
First Submitted Date  ICMJE October 27, 2016
First Posted Date  ICMJE November 3, 2016
Results First Submitted Date  ICMJE April 2, 2018
Results First Posted Date  ICMJE June 25, 2018
Last Update Posted Date September 28, 2018
Study Start Date  ICMJE November 2016
Actual Primary Completion Date April 20, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 23, 2018)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 2, 2016)
  • Bacterial composition before and after SDF application measured by species diversity (number) [ Time Frame: One month ]
  • Bacterial composition before and after SDF application measured by species relative abundance (%) [ Time Frame: One month ]
  • Caries arrest of teeth measured by change in size (mm) [ Time Frame: One month ]
  • Caries arrest of teeth measured by change in dentin color (Yellow, brown, black) [ Time Frame: One month ]
  • Caries Arrest of Teeth Measured by Change in Dentin Texture (Soft, Hard) [ Time Frame: One month ]
Change History Complete list of historical versions of study NCT02953886 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 23, 2018)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 2, 2016)
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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Silver Diamine Fluoride (SDF) on Bacteria Involved in Root or Cervical Carious Lesions
Official Title  ICMJE The Effect of Silver Diamine Fluoride (SDF) on Bacteria Involved in Root or Cervical Carious Lesions Using HOMINGS Technology. A Clinical Study
Brief Summary The study will compare bacteria levels in cavities before and after silver diamine fluoride (SDF) 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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Caries
Intervention  ICMJE 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
Study Arms  ICMJE 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.
Intervention: Device: Silver Diamine Fluoride (SDF)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 1, 2017)
21
Original Estimated Enrollment  ICMJE
 (submitted: November 2, 2016)
20
Actual Study Completion Date  ICMJE April 20, 2017
Actual Primary Completion Date April 20, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02953886
Other Study ID Numbers  ICMJE HUM00117560
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Heba Mitwalli, University of Michigan
Study Sponsor  ICMJE Heba Mitwalli
Collaborators  ICMJE The Forsyth Institute
Investigators  ICMJE
Principal Investigator: Heba Mitwalli, DDS University of Michigan
Study Chair: Margherita Fontana, DDS, PhD University of Michigan
PRS Account University of Michigan
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP