Silver and Fluoride Salivary Levels After the Application of Silver Fluoride

NCT01860391 | Completed

• 1 other identifier: 0000060585
• Study Type: interventional
• Target: 6
• Locations: 0 countries
• Sites: N/A

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

Conditions

Dentin Hypersensitivity

Keywords

Silver; Fluoride; Diammine Silver Fluoride; Saliva

Outcome Measures

Primary Outcomes (1)

• Silver and Fluoride levels in saliva

  The daily fluoride and silver levels in saliva will be determined after the application of silver fluoride.

  7 days

Study Arms (1)

Application of Diammine SIlver Fluoride

EXPERIMENTAL

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

Interventions

Diammine Silver Fluoride DEVICE

Diammine SIlver Fluoride will be applied to teeth. The levels of silver and fluoride in saliva will be measure up to 7 days

Also known as: Silver FLuoride, Saforide

Application of Diammine SIlver Fluoride

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad Peruana Cayetano Heredia: lead

MeSH Terms

Conditions

Dentin Sensitivity

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• Adriana Romo, DDS

  Universidad Peruana Cayetano Heredia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2013
• First Posted: May 22, 2013
• Study Start: December 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: May 22, 2013

Record last verified: 2013-05