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Trial record 85 of 1200 for:    tooth decay

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

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Caries
Intervention Device: Silver Diamine Fluoride (SDF)
Enrollment 21
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Silver Diamine Fluoride (SDF)
Hide Arm/Group Description

Application of Silver Diamine Fluoride (SDF) to root or cervical carious lesions (cavities). Collection of plaque pre- and one month post-SDF application.

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

Period Title: Overall Study
Started 20
Completed 20
Not Completed 0
Arm/Group Title Silver Diamine Fluoride (SDF)
Hide Arm/Group Description

Application of Silver Diamine Fluoride (SDF) to root or cervical carious lesions (cavities). Collection of plaque pre- and one month post-SDF application.

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

Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
<=18 years
0
   0.0%
Between 18 and 65 years
13
  65.0%
>=65 years
7
  35.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
8
  40.0%
Male
12
  60.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
3
  15.0%
White
16
  80.0%
More than one race
0
   0.0%
Unknown or Not Reported
1
   5.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 20 participants
20
 100.0%
1.Primary Outcome
Title Change in Bacterial Composition Before and One Month After SDF Application to Root or Cervical Caries Lesions
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Silver Diamine Fluoride (SDF)
Hide Arm/Group Description:

Application of Silver Diamine Fluoride (SDF) to root or cervical carious lesions (cavities). Collection of plaque pre- and one month post-SDF application.

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

Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: bacterial count
Baseline 1890087
One month after SDF 1959306
2.Primary Outcome
Title Caries Arrest of Teeth Measured by Change in Dentin Texture (Soft, Hard)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Silver Diamine Fluoride (SDF)
Hide Arm/Group Description:

Application of Silver Diamine Fluoride (SDF) to root or cervical carious lesions (cavities). Collection of plaque pre- and one month post-SDF application.

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

Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: cervical lesions
Soft 8
Hard 12
3.Secondary Outcome
Title Patient Assessment of Appearance of Treated Tooth (Concern With the Appearance of Study Tooth, Desire for the Study Tooth to be Filled)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Silver Diamine Fluoride (SDF)
Hide Arm/Group Description:

Application of Silver Diamine Fluoride (SDF) to root or cervical carious lesions (cavities). Collection of plaque pre- and one month post-SDF application.

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

Overall Number of Participants Analyzed 20
Measure Type: Count of Participants
Unit of Measure: Participants
Concerned with appearance of tooth
1
   5.0%
Desire for tooth to be filled
18
  90.0%
Time Frame 7 months
Adverse Event Reporting Description Number of Participants at Risk is equal to the number of participants enrolled
 
Arm/Group Title Silver Diamine Fluoride (SDF)
Hide Arm/Group Description

Application of Silver Diamine Fluoride (SDF) to root or cervical carious lesions (cavities). Collection of plaque pre- and one month post-SDF application.

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

All-Cause Mortality
Silver Diamine Fluoride (SDF)
Affected / at Risk (%)
Total   0/21 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Silver Diamine Fluoride (SDF)
Affected / at Risk (%) # Events
Total   0/21 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Silver Diamine Fluoride (SDF)
Affected / at Risk (%) # Events
Total   21/21 (100.00%)    
General disorders   
Unfavorable taste * [1]  3/21 (14.29%)  3
Burning sensation * [1]  1/21 (4.76%)  1
Black stain * [2]  21/21 (100.00%)  21
*
Indicates events were collected by non-systematic assessment
[1]
When applying the SDF
[2]
Subjects had black stain in the cavity
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Emily Yanca
Organization: University of Michigan
Phone: 734-763-3988
Responsible Party: Heba Mitwalli, University of Michigan
ClinicalTrials.gov Identifier: NCT02953886     History of Changes
Other Study ID Numbers: HUM00117560
First Submitted: October 27, 2016
First Posted: November 3, 2016
Results First Submitted: April 2, 2018
Results First Posted: June 25, 2018
Last Update Posted: September 28, 2018