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Pharmacokinetics of Diammine Silver Fluoride

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ClinicalTrials.gov Identifier: NCT01664871
Recruitment Status : Completed
First Posted : August 14, 2012
Last Update Posted : August 14, 2012
Sponsor:
Information provided by (Responsible Party):
Universidad Peruana Cayetano Heredia

Brief Summary:

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).


Condition or disease Intervention/treatment Phase
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

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
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
Study Start Date : July 2011
Actual Primary Completion Date : August 2011
Actual Study Completion Date : September 2011

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U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   10 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects with dental abfraction, erosion or root caries at least in one upper or lower premolar or molar
  • Those teeth should have hypersensitivity with cold air

Exclusion Criteria:

  • Use of any type of hypersensitivity toothpaste
  • Use of pain medication
  • Pregnant women
  • Individuals with sensitivity to silver or other metal ions

Information from the National Library of Medicine

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): NCT01664871


Locations
Peru
Universidad Catolica Santa Maria
Arequipa, Peru
Sponsors and Collaborators
Universidad Peruana Cayetano Heredia
Investigators
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Universidad Peruana Cayetano Heredia
ClinicalTrials.gov Identifier: NCT01664871     History of Changes
Other Study ID Numbers: UC1110
First Posted: August 14, 2012    Key Record Dates
Last Update Posted: August 14, 2012
Last Verified: August 2012

Additional relevant MeSH terms:
Erythema
Skin Diseases
Fluorides
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs