Trial Outcomes & Findings for The Effect of Silver Diamine Fluoride (SDF) on Bacteria Involved in Root or Cervical Carious Lesions (NCT NCT02953886)
NCT ID: NCT02953886
Last Updated: 2018-09-28
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
21 participants
Primary outcome timeframe
baseline, One month after SDF
Results posted on
2018-09-28
Participant Flow
Participant milestones
| Measure |
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.
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 Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effect of Silver Diamine Fluoride (SDF) on Bacteria Involved in Root or Cervical Carious Lesions
Baseline characteristics by cohort
| Measure |
Silver Diamine Fluoride (SDF)
n=20 Participants
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
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline, One month after SDFUsing 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.
Outcome measures
| Measure |
Silver Diamine Fluoride (SDF)
n=20 Participants
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
|
|---|---|
|
Change in Bacterial Composition Before and One Month After SDF Application to Root or Cervical Caries Lesions
Baseline
|
1890087 bacterial count
|
|
Change in Bacterial Composition Before and One Month After SDF Application to Root or Cervical Caries Lesions
One month after SDF
|
1959306 bacterial count
|
PRIMARY outcome
Timeframe: One monthCaries 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.
Outcome measures
| Measure |
Silver Diamine Fluoride (SDF)
n=20 Participants
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
|
|---|---|
|
Caries Arrest of Teeth Measured by Change in Dentin Texture (Soft, Hard)
Soft
|
8 cervical lesions
|
|
Caries Arrest of Teeth Measured by Change in Dentin Texture (Soft, Hard)
Hard
|
12 cervical lesions
|
SECONDARY outcome
Timeframe: One monthEach 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.
Outcome measures
| Measure |
Silver Diamine Fluoride (SDF)
n=20 Participants
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
|
|---|---|
|
Patient Assessment of Appearance of Treated Tooth (Concern With the Appearance of Study Tooth, Desire for the Study Tooth to be Filled)
Concerned with appearance of tooth
|
1 Participants
|
|
Patient Assessment of Appearance of Treated Tooth (Concern With the Appearance of Study Tooth, Desire for the Study Tooth to be Filled)
Desire for tooth to be filled
|
18 Participants
|
Adverse Events
Silver Diamine Fluoride (SDF)
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Silver Diamine Fluoride (SDF)
n=21 participants at risk
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
|
|---|---|
|
General disorders
Unfavorable taste
|
14.3%
3/21 • Number of events 3 • 7 months
Number of Participants at Risk is equal to the number of participants enrolled
|
|
General disorders
Burning sensation
|
4.8%
1/21 • Number of events 1 • 7 months
Number of Participants at Risk is equal to the number of participants enrolled
|
|
General disorders
Black stain
|
100.0%
21/21 • Number of events 21 • 7 months
Number of Participants at Risk is equal to the number of participants enrolled
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place