Back to resultsThe Effect of Silver Diamine Fluoride (SDF) on Bacteria Involved in Root or Cervical Carious Lesions
Primary Purpose
Caries
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Silver Diamine Fluoride (SDF)
Sponsored by
About this trial
This is an interventional treatment trial for Caries focused on measuring Caries, Cavity, Silver Diamine Fluoride (SDF), HOMINGS
Eligibility 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.
Sites / Locations
- University of Michigan School of Dentistry
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Silver Diamine Fluoride (SDF)
Arm Description
Application of Silver Diamine Fluoride (SDF) to root or cervical carious lesions (cavities). Collection of plaque pre- and one month post-SDF application.
Outcomes
Primary Outcome Measures
Change in Bacterial Composition Before and One Month After SDF Application to Root or Cervical Caries Lesions
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)
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
Patient Assessment of Appearance of Treated Tooth (Concern With the Appearance of Study Tooth, Desire for the Study Tooth to be Filled)
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.
Full Information
NCT ID
NCT02953886
First Posted
October 27, 2016
Last Updated
September 27, 2018
Sponsor
Heba Mitwalli
Collaborators
The Forsyth Institute
1. Study Identification
Unique Protocol Identification Number
NCT02953886
Brief Title
The Effect of Silver Diamine Fluoride (SDF) on Bacteria Involved in Root or Cervical Carious Lesions
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 Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
November 2016 (undefined)
Primary Completion Date
April 20, 2017 (Actual)
Study Completion Date
April 20, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Heba Mitwalli
Collaborators
The Forsyth Institute
4. Oversight
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caries
Keywords
Caries, Cavity, Silver Diamine Fluoride (SDF), HOMINGS
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Silver Diamine Fluoride (SDF)
Arm Type
Experimental
Arm Description
Application of Silver Diamine Fluoride (SDF) to root or cervical carious lesions (cavities). Collection of plaque pre- and one month post-SDF application.
Intervention Type
Device
Intervention Name(s)
Silver Diamine Fluoride (SDF)
Other Intervention Name(s)
Silver Dental Arrest
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in Bacterial Composition Before and One Month After SDF Application to Root or Cervical Caries Lesions
Description
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.
Time Frame
baseline, One month after SDF
Title
Caries Arrest of Teeth Measured by Change in Dentin Texture (Soft, Hard)
Description
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.
Time Frame
One month
Secondary Outcome Measure Information:
Title
Patient Assessment of Appearance of Treated Tooth (Concern With the Appearance of Study Tooth, Desire for the Study Tooth to be Filled)
Description
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.
Time Frame
One month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heba Mitwalli, DDS
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Margherita Fontana, DDS, PhD
Organizational Affiliation
University of Michigan
Official's Role
Study Chair
Facility Information:
Facility Name
University of Michigan School of Dentistry
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Silver Diamine Fluoride (SDF) on Bacteria Involved in Root or Cervical Carious Lesions
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