Pharmacokinetics of Diammine Silver Fluoride

NCT01664871 | Completed Phase 1

• 1 other identifier: UC1110
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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). .

Conditions

Fluoride and Silver Pharmacokinetics of DSF Applied Topically to Teeth of Adults. Erythema, Bleeding, White Changes, Ulceration and Pigmentation Were Assessed

Outcome Measures

Primary Outcomes (2)

• Level of Fluoride in Plasma

  Samples were thawed and analyzed in duplicate or triplicate using the diffusion and detection method with hexamethyldisiloxane (HMDS) and Orion F-sensitive electrode

  baseline, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours

• Level of Silver in Plasma

  Samples were thawed and analyzed using Inductively Coupled Plasma-Mass Spectrometry

  baseline, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours

Secondary Outcomes (1)

• Gingival alterations

  baseline, immediately after treatment, 24 hours after treatment

Study Arms (1)

Levels of SIlver and Fluoride in Plasma

EXPERIMENTAL

Device: DIammine SIlver Fluoride

Interventions

DIammine SIlver Fluoride DEVICE

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.

Levels of SIlver and Fluoride in Plasma

Eligibility Criteria

• Age: 10 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Universidad Peruana Cayetano Heredia: lead

Study Sites (1)

Universidad Catolica Santa Maria

Arequipa, Peru

Location

Related Publications (1)

• Vasquez E, Zegarra G, Chirinos E, Castillo JL, Taves DR, Watson GE, Dills R, Mancl LL, Milgrom P. Short term serum pharmacokinetics of diammine silver fluoride after oral application. BMC Oral Health. 2012 Dec 31;12:60. doi: 10.1186/1472-6831-12-60.

  PMID: 23272643 DERIVED

MeSH Terms

Conditions

Hemorrhage; Ulcer

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Peter Milgrom, DDS

  University of Washington

  PRINCIPAL INVESTIGATOR

• Elsa Vasquez, DDS

  Universidad Catolica Santa Maria Arequipa

  STUDY DIRECTOR

• Jorge Castillo, DDS MSD PhD

  Universidad Peruana Cayetano Heredia

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2012
• First Posted: August 14, 2012
• Study Start: July 1, 2011
• Primary Completion: August 1, 2011
• Study Completion: September 1, 2011
• Last Updated: August 14, 2012

Record last verified: 2012-08

Locations

PE (1)