Silver and Fluoride Salivary Levels After the Application of Silver Fluoride

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. Read our disclaimer for details. Identifier: NCT01860391
Recruitment Status : Completed
First Posted : May 22, 2013
Last Update Posted : May 22, 2013
Information provided by (Responsible Party):
Universidad Peruana Cayetano Heredia

Brief Summary:

The aim of the study is to measure salivary fluoride and silver levels up to 7 days post-treatment.

The participants will be 6 healthy adults. They will be given a fluoride free toothpaste to use the day before the study and all during the study.

3 participants will have 6 teeth treated (Group A).3 participants will have 28 teeth treated each on the facial aspect (Group B).

On day 0, the participant will be given 25 ml of de-ionized fluoride free water to swish in the mouth and spit the entire contents into a 50 ml collection tube. This will be done 3 times.

On day 0, 10 minutes after the rinsing and spitting, the participant will provide a unstimulated salivary sample into a universal collection tube until 5 ml are collected. The tubes with saliva will be stored on ice and then frozen at -20oC for transfer to the lab at the University of Washington.

On Day 0, Isolation and application of silver fluoride.

The quadrant will be isolated with cotton rolls, and surrounding gingiva will be covered with petroleum jelly to provide additional protection.

After application, participant will be given 25 ml of fluoride free water to rinse as in 1 above and water collected. This will be done 10 times.

DAY 1-6 Salivary Collection

Measures: Fluoride will be measured using standard fluoride electrode analysis (Martinez-Mier et al., 2011). Silver will be measured using Inductively Coupled Plasma-Mass Spectrometry (EPA 6020a Rev.1 2007) at the University of Washington

Condition or disease Intervention/treatment Phase
Dentin Hypersensitivity Device: Diammine Silver Fluoride Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Official Title: Salivary Levels of Fluoride and Silver 7 Days After Treatment With Diammine Silver Fluoride
Study Start Date : December 2012
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Application of Diammine SIlver Fluoride

GROUP A (6 TEETH): 18 mcL will be expressed from a Hamilton syringe into a dappen dish, and then a single preweighed microbrush will be used to apply the material to the tooth surface after drying with cotton gauze. The 6 teeth will be treated consecutively until all the material in the dappen dish will be used. Then the brush will be reweighed to establish the non-applied amount.

GROUP B (28 TEETH) Measure out 3 mcL X number of teeth present into dappen dish. Procedure is the same.

Device: Diammine Silver Fluoride
Diammine SIlver Fluoride will be applied to teeth. The levels of silver and fluoride in saliva will be measure up to 7 days
Other Names:
  • Silver FLuoride
  • Saforide

Primary Outcome Measures :
  1. Silver and Fluoride levels in saliva [ Time Frame: 7 days ]
    The daily fluoride and silver levels in saliva will be determined after the application of silver fluoride.

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Patients with at least one canine or premolar
  • Patients with Dentin hypersensitivity
  • Patients with healthy gingiva

Exclusion Criteria:

  • Patients taking any of these medication: antidepressivem anticonvulsive, antihistaminic, antihypertension, antihemetic, antiespasmodic.
  • Pregnancy
  • Patients under radiation therapy
  • Patients under chemotherapy
  • Patients with alterations of salivary glands like Sjogren syndrome or Diabetes Mellitus with Xerostomia
  • Patients with sensitivity to silver or other ions of heavy metals

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 identifier (NCT number): NCT01860391

Sponsors and Collaborators
Universidad Peruana Cayetano Heredia
Principal Investigator: Adriana Romo, DDS Universidad Peruana Cayetano Heredia

Responsible Party: Universidad Peruana Cayetano Heredia Identifier: NCT01860391     History of Changes
Other Study ID Numbers: 0000060585
First Posted: May 22, 2013    Key Record Dates
Last Update Posted: May 22, 2013
Last Verified: May 2013

Keywords provided by Universidad Peruana Cayetano Heredia:
Diammine Silver Fluoride

Additional relevant MeSH terms:
Dentin Sensitivity
Immune System Diseases
Tooth Diseases
Stomatognathic Diseases
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs