In Vivo Comparison of Salivary Fluoride Levels Following the Application of Different 5% NaF Varnishes
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Purpose
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. Subjects will be recruited at the University of Michigan School of Dentistry and will participate in a 15 minute clinical session at the beginning of each study arm, followed by 6 saliva collection recalls. During these sessions a fluoride varnish or placebo will be applied to their teeth, and subsequent salivary samples will be taken 1 hour, 4 hours, 6 hours, 24 hours, and 48 hours after the application. All subjects will receive 3 commercially available varnishes, and a placebo varnish. Between applications there will be a minimum of 2 weeks wash-out period. 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.
Specific Aims
- Determine the concentration of fluoride available in the oral cavity at different time periods after the application of three different 5% NaF varnishes as measured in unstimulated human saliva.
- Compare the different patterns of fluoride release from each of the varnishes by comparing the fluoride concentration in saliva at corresponding time periods .
- Evaluate the validity of an in vitro model used to measure fluoride release from varnishes.
Percentage difference in fluoride release between the in vivo and in vitro data obtained from the same products will be compared.
| Condition | Intervention |
|---|---|
|
Dental Caries |
Device: Dental Varnish (Enamel Pro, Duraphat, Vanish) Device: Placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-availability Study Intervention Model: Crossover Assignment Masking: Single Blind (Subject) Primary Purpose: Basic Science |
| Official Title: | In Vivo Comparison of Salivary Fluoride Levels Following the Application of Different 5% NaF Varnishes |
- Determine the concentration of fluoride available in the oral cavity at different time periods after the application of three different 5% NaF varnishes as measured in unstimulated human saliva [ Time Frame: 48 Hours ] [ Designated as safety issue: No ]
- Compare the different patterns of fluoride release from each of the varnishes [ Time Frame: 48 Hours ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 15 |
| Study Start Date: | June 2012 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Enamel Pro 5% NaF |
Device: Dental Varnish (Enamel Pro, Duraphat, Vanish)
3 varnishes with 5% NaF active ingredient and one bland varnish (No NaF)
Other Names:
|
| Active Comparator: Duraphat 5% NaF |
Device: Dental Varnish (Enamel Pro, Duraphat, Vanish)
3 varnishes with 5% NaF active ingredient and one bland varnish (No NaF)
Other Names:
|
| Active Comparator: Vanish 5% NaF |
Device: Dental Varnish (Enamel Pro, Duraphat, Vanish)
3 varnishes with 5% NaF active ingredient and one bland varnish (No NaF)
Other Names:
|
| Placebo Comparator: Placebo |
Device: Placebo
0.5 mls applied topically to buccal surfaces of teeth
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| United States, Michigan | |
| University of Michigan School of Dentistry | |
| Ann Arbor, Michigan, United States, 48104 | |
| Study Chair: | Peter Yaman, DDS, MS | University of Michigan |
| Study Chair: | Gisele Neiva, DDS, MS | University of Michigan School of Dentsitry |
| Study Chair: | Joseph Dennison, DDS, MS | University of Michigan |
| Study Director: | Carlos Gonzalez, DDS, MSD, PhD | University of Michigan |
More Information
No publications provided
| Responsible Party: | Danika J Downey, Graduate Student, Restorative Dentistry, University of Michigan |
| ClinicalTrials.gov Identifier: | NCT01629290 History of Changes |
| Other Study ID Numbers: | HUM00062943 |
| Study First Received: | June 10, 2012 |
| Last Updated: | August 5, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Dental Caries Tooth Demineralization Tooth Diseases Stomatognathic Diseases Fluorides Sodium Fluoride |
Sodium fluoride topical preparation Cariostatic Agents Protective Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013