Trial Outcomes & Findings for Silver Diamine Fluoride Pilot Study (SDF) (NCT NCT02591147)
NCT ID: NCT02591147
Last Updated: 2023-03-14
Results Overview
Determine if there is a change in the size of the dental cavity from baseline to 12 months after blinded treatment with either Silver Diamine Fluoride 38% or placebo (sterile water). This measurement will be assessed using radiographic examination to determine if there is either evidence of no radiographic change, radiographic progression, or radiographic regression.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
41 participants
Primary outcome timeframe
Baseline, 12 months after blinded treatment with either Silver Diamine Fluoride 38% or placebo (sterile water)
Results posted on
2023-03-14
Participant Flow
Participant milestones
| Measure |
Silver Diamine Fluoride 38%
Group 1 (SDF 38%) will receive the application of silver diammine fluoride (38% SDF solution) in addition to 5% sodium fluoride varnish to each approximal carious lesion (scores RA1,RA2,RA3) in a posterior tooth (premolar or molar) that is in contact with an adjacent tooth, using super floss, for a duration of 3 minutes under rubber dam isolation.
Silver Diamine Fluoride 38%: Group 1 (SDF group) subjects will receive the application of silver diamine fluoride (38% SDF solution) in addition to 5% Fluoride varnish to each approximal incipiency, using super floss, for a duration of 3 minutes under rubber dam isolation.
|
Placebo (Sterile Water)
Group 2 Placebo (control) will receive the application of sterile water (placebo) in addition to 5% sodium fluoride varnish to each approximal carious lesion (scores RA1,RA2,RA3) in a posterior tooth (premolar or molar) that is in contact with an adjacent tooth, using super floss, for a duration of 3 minutes under rubber dam isolation.
Group 2 (Placebo): Group 2 (Placebo) subjects will receive application of sterile water (placebo) in addition to 5% Fluoride varnish to each approximal incipiency, using super floss, for a duration of 3 minutes under rubber dam isolation.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
21
|
|
Overall Study
COMPLETED
|
18
|
16
|
|
Overall Study
NOT COMPLETED
|
2
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Silver Diamine Fluoride 38%
n=20 Participants
Group 1 (SDF 38%) will receive the application of silver diammine fluoride (38% SDF solution) in addition to 5% sodium fluoride varnish to each approximal carious lesion (scores RA1,RA2,RA3) in a posterior tooth (premolar or molar) that is in contact with an adjacent tooth, using super floss, for a duration of 3 minutes under rubber dam isolation.
Silver Diamine Fluoride 38%: Group 1 (SDF group) subjects will receive the application of silver diamine fluoride (38% SDF solution) in addition to 5% Fluoride varnish to each approximal incipiency, using super floss, for a duration of 3 minutes under rubber dam isolation.
|
Placebo (Sterile Water)
n=21 Participants
Group 2 Placebo (control) will receive the application of sterile water (placebo) in addition to 5% sodium fluoride varnish to each approximal carious lesion (scores RA1,RA2,RA3) in a posterior tooth (premolar or molar) that is in contact with an adjacent tooth, using super floss, for a duration of 3 minutes under rubber dam isolation.
Group 2 (Placebo): Group 2 (Placebo) subjects will receive application of sterile water (placebo) in addition to 5% Fluoride varnish to each approximal incipiency, using super floss, for a duration of 3 minutes under rubber dam isolation.
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=20 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=41 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=20 Participants
|
21 Participants
n=21 Participants
|
41 Participants
n=41 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=20 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=41 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=20 Participants
|
13 Participants
n=21 Participants
|
26 Participants
n=41 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=20 Participants
|
8 Participants
n=21 Participants
|
15 Participants
n=41 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: Baseline, 12 months after blinded treatment with either Silver Diamine Fluoride 38% or placebo (sterile water)Determine if there is a change in the size of the dental cavity from baseline to 12 months after blinded treatment with either Silver Diamine Fluoride 38% or placebo (sterile water). This measurement will be assessed using radiographic examination to determine if there is either evidence of no radiographic change, radiographic progression, or radiographic regression.
Outcome measures
| Measure |
Silver Diamine Fluoride 38%
n=18 Participants
Group 1 (SDF 38%) will receive the application of silver diammine fluoride (38% SDF solution) in addition to 5% sodium fluoride varnish to each approximal carious lesion (scores RA1,RA2,RA3) in a posterior tooth (premolar or molar) that is in contact with an adjacent tooth, using super floss, for a duration of 3 minutes under rubber dam isolation.
Silver Diamine Fluoride 38%: Group 1 (SDF group) subjects will receive the application of silver diamine fluoride (38% SDF solution) in addition to 5% Fluoride varnish to each approximal incipiency, using super floss, for a duration of 3 minutes under rubber dam isolation.
|
Placebo (Sterile Water)
n=16 Participants
Group 2 Placebo (control) will receive the application of sterile water (placebo) in addition to 5% sodium fluoride varnish to each approximal carious lesion (scores RA1,RA2,RA3) in a posterior tooth (premolar or molar) that is in contact with an adjacent tooth, using super floss, for a duration of 3 minutes under rubber dam isolation.
Group 2 (Placebo): Group 2 (Placebo) subjects will receive application of sterile water (placebo) in addition to 5% Fluoride varnish to each approximal incipiency, using super floss, for a duration of 3 minutes under rubber dam isolation.
|
|---|---|---|
|
Assessment of Radiographic Change in Dental Cavity
No radiographic change
|
9 Participants
|
11 Participants
|
|
Assessment of Radiographic Change in Dental Cavity
Radiographic progression
|
3 Participants
|
2 Participants
|
|
Assessment of Radiographic Change in Dental Cavity
Radiographic regression
|
6 Participants
|
3 Participants
|
Adverse Events
Silver Diamine Fluoride 38%
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo (Sterile Water)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Justine Kolker
University of Iowa College of Dentistry
Phone: (319) 335-7583
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place