University of Iowa
Iowa City, Iowa, 52242, United States
NCT Number: NCT02591147
This pilot trial is randomized, double-blind, and placebo-controlled trial with two parallel arms: an intervention group using silver diamine fluoride (SDF) and a placebo group (control). 60 eligible healthy adults will be enrolled in the study and randomly assigned to one of the two treatment groups. Both groups will receive the traditional preventive measures including cleanings, Fluoride varnish, diet analysis and counseling. Study participants will be followed for one year and caries progression will be radiographically monitored.
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Notify Me21 year–64 year
All sexes
Interventional
Not applicable
Iowa City, Iowa, 52242, United States
This pilot study will compare 1) Silver diamine fluoride (SDF) and fluoride varnish to 2) Placebo and fluoride varnish (conventional prevention) in the management of early approximal carious lesions. Early approximal carious lesions refers to decay between teeth, diagnosed with radiographs, not extending more than 1/3 of the way into dentin. Management of early approximal carious lesions refers to halting lesion progression, or encouraging lesion reversal after an early carious lesion is detected.
SDF provides a novel, low-cost intervention option for managing early carious lesions that could potentially bridge the 'gap' between non-operative and operative options; thus, postponing the first placement of a restoration. SDF has been used in arresting carious lesions for more than 100 years. However, SDF has never been tested in the arrest of approximal caries lesions in permanent teeth.
SDF acts to both prevent and arrest tooth decay in multiple ways: 1) it acts on the body of carious lesions by precipitating silver ion into the lesion, thus blocking diffusion pathways for cariogenic acids; 2) it interacts with dental enamel leading to the formation of fluoroapatite crystals making the tooth surface more acid resistant; and 3) the precipitated silver from SDF acts as a bactericidal agent disturbing the formation of cariogenic biofilm.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: 38% SDF
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.
Other names: Sterile Water
Time frame: 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.
Justine Kolker
Other
Effectiveness of Silver Diamine Fluoride in Arresting Early Approximal Carious Lesion Progression: A Pilot Study
Acronym: SDF
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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