In Vivo Comparison of Salivary Fluoride Levels Following the Application of Different 5% NaF Varnishes

Completed · Not applicable · Has a placebo group

Conditions studied: Dental Caries

In brief

This study will be a cross-over single blinded clinical study to evaluate the in vitro fluoride release of three different brands of 5% NaF varnish. The goal of this study is to determine if different formulations of varnish lead to differing amounts of fluoride release. Despite their similar concentrations of NaF (5%), some in vitro data have suggested that they may differ in the amount of fluoride release. Determining fluoride release of these varnishes in vivo is important in assessing both the safety and efficacy of the product.

Key facts

Study ID

NCT01629290

Run by

University of Michigan

People needed

15

Starts

2012-06-01

Expected to finish

2015-12-01

Last updated by the study team

2017-05-22

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• All subjects between 18-65 years of age and do not fall under any of the exclusion criteria

You may not qualify if…

• Subjects with less than 20 teeth
• Subjects with significant untreated disease to include gum disease, extensive decay, or the need for pre-medication prior to dental treatment
• Pregnant or lactating women
• Subjects with a history of allergy to materials to be used in the study
• Subjects unable to produce adequate saliva for sampling
• Subjects deemed low risk for dental caries (no history of restorative work or presence of caries lesions)
• Subjects unable to be available for all 4 cycles of the study

Where it is running

• University of Michigan School of Dentistry — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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