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Fluoride Treatment
Silver Diamine Fluoride 38% for Tooth Decay (SDF Trial)
N/A
Waitlist Available
Led By Michael Kanellis, DDS, MS
Research Sponsored by Justine Kolker
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 12 months after blinded treatment with either silver diamine fluoride 38% or placebo (sterile water)
Awards & highlights
SDF Trial Summary
This study is evaluating whether silver diamine fluoride (SDF) is effective in preventing caries in healthy adults.
SDF Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 12 months after blinded treatment with either silver diamine fluoride 38% or placebo (sterile water)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 12 months after blinded treatment with either silver diamine fluoride 38% or placebo (sterile water)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Assessment of Radiographic Change in Dental Cavity
Secondary outcome measures
Incidence of caries in all other teeth in the study subject
SDF Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Silver Diamine Fluoride 38%Active Control1 Intervention
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.
Group II: Placebo (Sterile water)Placebo Group1 Intervention
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.
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Who is running the clinical trial?
Justine KolkerLead Sponsor
Michael Kanellis, DDS, MSPrincipal InvestigatorUniversity of Iowa
Justine Kolker, DDS, MSPrincipal InvestigatorUniversity of Iowa
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