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
|Condition or disease||Intervention/treatment||Phase|
|Caries||Device: Silver Diamine Fluoride (SDF)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
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|