Silver Diamine Fluoride Pilot Study (SDF)



Status:Recruiting
Conditions:Other Indications, Dental
Therapuetic Areas:Dental / Maxillofacial Surgery, Other
Healthy:No
Age Range:21 - 64
Updated:8/31/2018
Start Date:October 2016
End Date:December 2020
Contact:Karen M Kluesner, RN
Email:karen-kluesner@uiowa.edu
Phone:319-335-7377

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Effectiveness of Silver Diamine Fluoride in Arresting Early Approximal Carious Lesion Progression: A Pilot Study

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.

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.

Inclusion Criteria:

- Presence of at least one approximal caries lesion (scores RA1, RA2, RA3 according to
the ICCMS radiographic scoring system) in one of the posterior teeth (premolars and
molars) presented with full contact with the adjacent tooth.

- All the surfaces eligible for this study will be included.

Exclusion Criteria:

- The approximal lesion detected in the radiograph has advanced dentine lesion (RB4,
RC5, or RC6)

- or is adjacent to a lesion that is either filled or will receive a filling at the time
of enrollment.
We found this trial at
1
site
101 Jessup Hall
Iowa City, Iowa 52242
(319) 335-3500
Phone: 319-335-7377
University of Iowa With just over 30,000 students, the University of Iowa is one of...
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Iowa City, IA
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