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| Name | Class |
|---|---|
| Delta Dental Fund of Michigan | OTHER |
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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.
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
Percentage difference in fluoride release between the in vivo and in vitro data obtained from the same products will be compared. Because the comparison of different patterns of fluoride release from the varnishes is accomplished by analyzing the fluoride available concentration levels, it was an error to list that secondary aim as a secondary - or indeed any sort of outcome measure. The outcome measure data for "patterns of fluoride release" is exactly that which has been fully disclosed in the Primary Outcome Measure data tables. Therefore the secondary outcome measure previously listed: Compare the different patterns of fluoride release from each of the varnishes, which was really never properly an outcome measure, but an aim, has been deleted, with no loss of data transparency.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enamel Pro | Active Comparator | Varnish containing 5%NaF |
|
| Duraphat | Active Comparator | Varnish containing 5%NaF |
|
| Vanish | Active Comparator | Varnish containing 5%NaF |
|
| Placebo | Placebo Comparator | Bland varnish containing no NaF |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enamel Pro | Device | Varnish treatment containing 5% NaF |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Fluoride Concentration and Release | Fluoride release as measured by concentration of fluoride available in the oral cavity at different time periods after the application of 5% NaF varnish and placebo as measured in unstimulated human saliva | Baseline, 1 hr, 4 hrs, 6 hrs, 26 hrs and 50 hrs |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 Chair |
| Carlos Gonzalez, DDS,MSD,PhD | University of Michigan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan School of Dentistry | Ann Arbor | Michigan | 48104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29614502 | Derived | Downey D, Dennison J, Eckert GJ, Flannagan SE, Neiva GF, Yaman P, Gonzalez-Cabezas C. Fluoride Levels in Unstimulated Whole Saliva following Clinical Application of Different 5% NaF Varnishes. Caries Res. 2018;52(6):431-438. doi: 10.1159/000485981. Epub 2018 Apr 3. |
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Treatment consisted of the application of 0.4 ml of either a 5% NaF varnish, or a placebo (no fluoride) varnish applied to the buccal surfaces of all the teeth. After a minimum of 2 weeks washout period, the next randomly assigned treatment was given. All subjects received the 4 different treatments.
15 subjects were enrolled. All 15 subjects participated in the four arms/groups and received all four interventions for a total of 60 treatments.
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| ID | Title | Description |
|---|---|---|
| FG000 | Varnishes and Placebo | Three dental varnishes with 5% NaF active ingredient (Enamel Pro, Duraphat and Vanish) and one bland varnish with no NaF applied to each subject at four timepoints. Each of the 15 participants received each of the four treatments, but the order followed was randomly arranged to be different, so there were twelve different patterns of assignment. Because all participants completed all four interventions, and the order was different for each, milestones are not used to indicate participation in each treatment, as that might imply a sequence, rather than simply that they received that intervention. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Varnish and Placebo | Three dental varnishes with 5% NaF active ingredient and placebo bland varnish containing no NaF |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Fluoride Concentration and Release | Fluoride release as measured by concentration of fluoride available in the oral cavity at different time periods after the application of 5% NaF varnish and placebo as measured in unstimulated human saliva | The 15 participants were each involved in each of the successive treatments with Enamel Pro, Duraphat, Vanish, and Placebo, (the order differed for each participant), and to show the differences between baseline and the different treatment levels, the baselines before each of the treatments is listed here along with the relevant treatment. | Posted | Mean | Standard Deviation | ppm | Baseline, 1 hr, 4 hrs, 6 hrs, 26 hrs and 50 hrs |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Enamel Pro | Dental varnish with 5% NaF active ingredient | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Danika Downey, DDS | University of Michigan School of Dentistry | 330-877-8783 | danika.downey@gmail.com |
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D003736 | Dental Cavity Lining |
| ID | Term |
|---|---|
| D017266 | Dental Prosthesis |
| D011476 | Prosthodontics |
| D003813 | Dentistry |
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| Duraphat | Device | Varnish treatment containing 5% NaF |
|
|
| Vanish | Device | Varnish treatment containing 5% NaF |
|
|
| Placebo | Device | Bland varnish containing no NaF |
|
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Duraphat |
Dental varnish with 5% NaF active ingredient |
| OG002 | Vanish | Dental varnish with 5% NaF active ingredient |
| OG003 | Placebo | Bland varnish containing no NaF |
|
|
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Placebo | Placebo bland varnish containing no NaF | 0 | 15 | 0 | 15 | 0 | 15 |
| EG002 | Duraphat | Dental varnish with 5% NaF active ingredient | 0 | 15 | 0 | 15 | 0 | 15 |
| EG003 | Vanish | Dental varnish with 5% NaF active ingredient | 0 | 15 | 0 | 15 | 0 | 15 |
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