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Pharmacokinetics of Diammine Silver Fluoride

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Universidad Peruana Cayetano Heredia
ClinicalTrials.gov Identifier:
NCT01664871
First received: August 10, 2012
Last updated: NA
Last verified: August 2012
History: No changes posted
  Purpose

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).

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Condition Intervention 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

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Characterization of Fluoride and Silver Pharmacokinetics of Diammine Silver Fluoride Applied Topically to Teeth of Adults

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Universidad Peruana Cayetano Heredia:

Primary Outcome Measures:
  • Level of Fluoride in Plasma [ Time Frame: baseline, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Samples were thawed and analyzed using Inductively Coupled Plasma-Mass Spectrometry


Secondary Outcome Measures:
  • Gingival alterations [ Time Frame: baseline, immediately after treatment, 24 hours after treatment ] [ Designated as safety issue: Yes ]
    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


Enrollment: 6
Study Start Date: July 2011
Study Completion Date: September 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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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  Eligibility

Ages Eligible for Study:   10 Years to 60 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by Universidad Peruana Cayetano Heredia

Additional 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
Study First Received: August 10, 2012
Last Updated: August 10, 2012
Health Authority: Peru: Ethics Committee

Additional relevant MeSH terms:
Hemorrhage
Ulcer
Erythema
Pathologic Processes
Skin Diseases
 Fluorides
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013