Pharmacokinetics of Diammine Silver Fluoride
There is growing worldwide interest in the use of diammine silver fluoride (DSF) as a topical agent to treat dentin hypersensitivity and dental caries. It has been available in various formulations for many years, but its safety profile has never been fully characterized.
This preliminary study determined the applied doses (3 teeth treated), maximum serum concentrations, and time to maximum serum concentration for fluoride and silver in 6 adults over 4 h. Fluoride was determined using the indirect diffusion method with a fluoride selective electrode, and silver was determined using inductively coupled plasma-mass spectrometry. The mean amount of DSF solution applied to the 3 teeth was 7.57 mg (6.04 µL).
|Fluoride and Silver Pharmacokinetics of DSF Applied Topically to Teeth of Adults. Erythema, Bleeding, White Changes, Ulceration and Pigmentation Were Assessed||Device: DIammine SIlver Fluoride||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Characterization of Fluoride and Silver Pharmacokinetics of Diammine Silver Fluoride Applied Topically to Teeth of Adults|
- Level of Fluoride in Plasma [ Time Frame: baseline, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours ]Samples were thawed and analyzed in duplicate or triplicate using the diffusion and detection method with hexamethyldisiloxane (HMDS) and Orion F-sensitive electrode
- Level of Silver in Plasma [ Time Frame: baseline, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours ]Samples were thawed and analyzed using Inductively Coupled Plasma-Mass Spectrometry
- Gingival alterations [ Time Frame: baseline, immediately after treatment, 24 hours after treatment ]The gingiva adjacent to the application of DSF and the mucosa generally were observed at baseline and 24 h after treatment. Erythema, bleeding, white changes, ulceration and pigmentation were assessed using methods developed for an earlier study
|Study Start Date:||July 2011|
|Study Completion Date:||September 2011|
|Primary Completion Date:||August 2011 (Final data collection date for primary outcome measure)|
|Experimental: Levels of SIlver and Fluoride in Plasma||
Device: DIammine SIlver Fluoride
Concentrations of Silver and Fluoride in the DSF used for study were 24.9% and 5.5%, respectively Average total weight (calculated volume) of Diammine Silver Fluoride applied was 7.57 mg (6.04 µL), corresponding to a mean application of 0.33 mg Fluoride based on the lot analysis. The mean total amount of Silver applied to the 3 teeth was 1.50 mg.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01664871
|Universidad Catolica Santa Maria|
|Principal Investigator:||Peter Milgrom, DDS||University of Washington|
|Study Director:||Elsa Vasquez, DDS||Universidad Catolica Santa Maria Arequipa|
|Study Chair:||Jorge Castillo, DDS MSD PhD||Universidad Peruana Cayetano Heredia|