Silver and Fluoride Salivary Levels After the Application of Silver Fluoride
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
|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|
- 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.
|Study Start Date:||December 2012|
|Study Completion Date:||December 2012|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01860391
|Principal Investigator:||Adriana Romo, DDS||Universidad Peruana Cayetano Heredia|