Trial Outcomes & Findings for In Vivo Comparison of Salivary Fluoride Levels Following the Application of Different 5% NaF Varnishes (NCT NCT01629290)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

15 participants

Primary outcome timeframe

Baseline, 1 hr, 4 hrs, 6 hrs, 26 hrs and 50 hrs

Results posted on

2017-05-22

Participant Flow

15 subjects were enrolled. All 15 subjects participated in the four arms/groups and received all four interventions for a total of 60 treatments.

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.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	15
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Varnish and Placebo n=15 Participants Three dental varnishes with 5% NaF active ingredient and placebo bland varnish containing no NaF
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Enamel Pro n=15 Participants Dental varnish with 5% NaF active ingredient	Duraphat n=15 Participants Dental varnish with 5% NaF active ingredient	Vanish n=15 Participants Dental varnish with 5% NaF active ingredient	Placebo n=15 Participants Bland varnish containing no NaF
Fluoride Concentration and Release Baseline	.09 ppm Standard Deviation .07	.07 ppm Standard Deviation .04	.09 ppm Standard Deviation .07	.09 ppm Standard Deviation .08
Fluoride Concentration and Release 1 hr following application	6.19 ppm Standard Deviation 4.09	18.94 ppm Standard Deviation 9.95	19.78 ppm Standard Deviation 14.57	.02 ppm Standard Deviation .02
Fluoride Concentration and Release 4 hrs following application	.67 ppm Standard Deviation .36	3.39 ppm Standard Deviation 4.83	4.12 ppm Standard Deviation 3.80	.01 ppm Standard Deviation .01
Fluoride Concentration and Release 6 hrs following application	.37 ppm Standard Deviation .2	1.82 ppm Standard Deviation 1.98	1.15 ppm Standard Deviation .79	.03 ppm Standard Deviation .04
Fluoride Concentration and Release 26 hrs following application	.4 ppm Standard Deviation .02	.19 ppm Standard Deviation .15	.2 ppm Standard Deviation .33	.02 ppm Standard Deviation .04
Fluoride Concentration and Release 50 hrs following application	.02 ppm Standard Deviation .03	.04 ppm Standard Deviation .03	.02 ppm Standard Deviation .03	.01 ppm Standard Deviation .01

Adverse Events

Enamel Pro

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Duraphat

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Vanish

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Danika Downey, DDS

University of Michigan School of Dentistry

Phone: 330-877-8783

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place