Dental Caries
Conditions
Brief 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.
Detailed description
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 1. 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. 2. Compare the different patterns of fluoride release from each of the varnishes by comparing the fluoride concentration in saliva at corresponding time periods . 3. 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. 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.
Interventions
DEVICEEnamel Pro
Varnish treatment containing 5% NaF
DEVICEDuraphat
Varnish treatment containing 5% NaF
DEVICEVanish
Varnish treatment containing 5% NaF
DEVICEPlacebo
Bland varnish containing no NaF
Sponsors
Delta Dental Fund of Michigan
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* All subjects between 18-65 years of age and do not fall under any of the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fluoride Concentration and Release | Baseline, 1 hr, 4 hrs, 6 hrs, 26 hrs and 50 hrs | 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 |
Countries
United States
Participant flow
Recruitment details
15 subjects were enrolled. All 15 subjects participated in the four arms/groups and received all four interventions for a total of 60 treatments.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Varnish and Placebo Three dental varnishes with 5% NaF active ingredient and placebo bland varnish containing no NaF | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | Varnish and Placebo |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants |
| Region of Enrollment United States | 15 participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 0 / 15 | 0 / 15 | 0 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 | 0 / 15 | 0 / 15 |
Outcome results
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
Time frame: Baseline, 1 hr, 4 hrs, 6 hrs, 26 hrs and 50 hrs
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Enamel Pro | Fluoride Concentration and Release | Baseline | .09 ppm | Standard Deviation 0.07 |
| Enamel Pro | Fluoride Concentration and Release | 1 hr following application | 6.19 ppm | Standard Deviation 4.09 |
| Enamel Pro | Fluoride Concentration and Release | 4 hrs following application | .67 ppm | Standard Deviation 0.36 |
| Enamel Pro | Fluoride Concentration and Release | 6 hrs following application | .37 ppm | Standard Deviation 0.2 |
| Enamel Pro | Fluoride Concentration and Release | 26 hrs following application | .4 ppm | Standard Deviation 0.02 |
| Enamel Pro | Fluoride Concentration and Release | 50 hrs following application | .02 ppm | Standard Deviation 0.03 |
| Duraphat | Fluoride Concentration and Release | 50 hrs following application | .04 ppm | Standard Deviation 0.03 |
| Duraphat | Fluoride Concentration and Release | 6 hrs following application | 1.82 ppm | Standard Deviation 1.98 |
| Duraphat | Fluoride Concentration and Release | Baseline | .07 ppm | Standard Deviation 0.04 |
| Duraphat | Fluoride Concentration and Release | 4 hrs following application | 3.39 ppm | Standard Deviation 4.83 |
| Duraphat | Fluoride Concentration and Release | 1 hr following application | 18.94 ppm | Standard Deviation 9.95 |
| Duraphat | Fluoride Concentration and Release | 26 hrs following application | .19 ppm | Standard Deviation 0.15 |
| Vanish | Fluoride Concentration and Release | 1 hr following application | 19.78 ppm | Standard Deviation 14.57 |
| Vanish | Fluoride Concentration and Release | 4 hrs following application | 4.12 ppm | Standard Deviation 3.8 |
| Vanish | Fluoride Concentration and Release | 6 hrs following application | 1.15 ppm | Standard Deviation 0.79 |
| Vanish | Fluoride Concentration and Release | 50 hrs following application | .02 ppm | Standard Deviation 0.03 |
| Vanish | Fluoride Concentration and Release | 26 hrs following application | .2 ppm | Standard Deviation 0.33 |
| Vanish | Fluoride Concentration and Release | Baseline | .09 ppm | Standard Deviation 0.07 |
| Placebo | Fluoride Concentration and Release | 26 hrs following application | .02 ppm | Standard Deviation 0.04 |
| Placebo | Fluoride Concentration and Release | 50 hrs following application | .01 ppm | Standard Deviation 0.01 |
| Placebo | Fluoride Concentration and Release | 1 hr following application | .02 ppm | Standard Deviation 0.02 |
| Placebo | Fluoride Concentration and Release | 6 hrs following application | .03 ppm | Standard Deviation 0.04 |
| Placebo | Fluoride Concentration and Release | Baseline | .09 ppm | Standard Deviation 0.08 |
| Placebo | Fluoride Concentration and Release | 4 hrs following application | .01 ppm | Standard Deviation 0.01 |