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
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Condition or disease | Intervention/treatment | Phase |
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Caries | Device: Silver Diamine Fluoride (SDF) | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 21 participants |
Allocation: | N/A |
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 |
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.
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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 |
- 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.
- 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.

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

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
United States, Michigan | |
University of Michigan School of Dentistry | |
Ann Arbor, Michigan, United States, 48109 |
Principal Investigator: | Heba Mitwalli, DDS | University of Michigan | |
Study Chair: | Margherita Fontana, DDS, PhD | University of Michigan |
Documents provided by Heba Mitwalli, University of Michigan:
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 |
Studies a U.S. FDA-regulated Device Product: | Yes |
Caries Cavity Silver Diamine Fluoride (SDF) HOMINGS |
Dental Caries Tooth Demineralization Tooth Diseases Stomatognathic Diseases |
Fluorides Cariostatic Agents Protective Agents Physiological Effects of Drugs |