Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Silver and Fluoride Salivary Levels After the Application of Silver Fluoride

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Universidad Peruana Cayetano Heredia
ClinicalTrials.gov Identifier:
NCT01860391
First received: May 20, 2013
Last updated: NA
Last verified: May 2013
History: No changes posted
  Purpose

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 Intervention
Dentin Hypersensitivity
Device: Diammine Silver Fluoride

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: Salivary Levels of Fluoride and Silver 7 Days After Treatment With Diammine Silver Fluoride

Resource links provided by NLM:


Further study details as provided by Universidad Peruana Cayetano Heredia:

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


Enrollment: 6
Study Start Date: December 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01860391

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

No publications provided

Responsible Party: Universidad Peruana Cayetano Heredia
ClinicalTrials.gov Identifier: NCT01860391     History of Changes
Other Study ID Numbers: 0000060585
Study First Received: May 20, 2013
Last Updated: May 20, 2013
Health Authority: Peru: Ethics Committee

Keywords provided by Universidad Peruana Cayetano Heredia:
Silver
Fluoride
Diammine Silver Fluoride
Saliva

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

ClinicalTrials.gov processed this record on November 25, 2014