N/A
Completed N=15
In Vivo Comparison of Salivary Fluoride Levels Following the Application of Different 5% NaF Varnishes
Source: ClinicalTrials.gov NCT01629290 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
May 2017
Primary outcomePrimary: Fluoride Concentration and Release — .09; .07; .09; .09 ppm
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fluoride Concentration and Release |
.09; .07; .09; .09; 6.19; 18.94 | — |
Eligibility Criteria
Inclusion Criteria
- All subjects between 18-65 years of age and do not fall under any of the exclusion criteria
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01629290). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.