Silver Diamine Fluoride Pilot Study (SDF) (SDF)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02591147|
Recruitment Status : Recruiting
First Posted : October 29, 2015
Last Update Posted : August 29, 2018
|Condition or disease||Intervention/treatment||Phase|
|Dental Caries||Drug: Silver Diamine Fluoride 38% Drug: Group 2 (Placebo)||Early Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Health Services Research|
|Official Title:||Effectiveness of Silver Diamine Fluoride in Arresting Early Approximal Carious Lesion Progression: A Pilot Study|
|Study Start Date :||October 2016|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
Active Comparator: 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.
Drug: 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.
Other Name: 38% SDF
Placebo Comparator: 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.
Drug: 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.
Other Name: Sterile Water
- Caries Progression [ Time Frame: 12 months ]comparison of radiographs to determine if there is caries progression in the subjects approximal lesions based on the radiographic examination.
- Incidence of caries in all other teeth in the study subject [ Time Frame: 12 months ]Count for new carious lesions developing over the course of the study period to assess the effect of SDF on preventing the development of early carious lesions
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02591147
|Contact: Karen M Kluesner, RNfirstname.lastname@example.org|
|Contact: Justine Kolker, DDS, MSemail@example.com|
|United States, Iowa|
|University of Iowa||Recruiting|
|Iowa City, Iowa, United States, 52242|
|Contact: Karen Kluesner, RN 319-335-7377 Karen-Kluesner@uiowa.edu|
|Contact: Justine Kolker, DDS 319-335-7583 firstname.lastname@example.org|
|Principal Investigator:||Michael Kanellis, DDS, MS||University of Iowa|
|Principal Investigator:||Justine Kolker, DDS, MS||University of Iowa|