An interventional study of Super Seal® Desensitizer and Acclean® Fluoride Varnish in Dentinal Hypersensitivity, sponsored by Procter and Gamble. Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-06-17.
Sponsored by Procter and Gamble · Not applicable, Interventional, and Treatment
The objective of this study is to compare professional treatments for dentinal hypersensitivity immediately following a single, professionally-applied treatment and again approximately 2 months following treatment.
Exclusion Criteria:
Professionally Applied
Device: Super Seal® Desensitizer
Professionally Applied
Device: Acclean® Fluoride Varnish
Single dose professional application.
Single dose professional application.
Change From Baseline Air Challenge
The Schiff Sensitivity Scale was assessed for each test tooth via an evaporative air challenge. The examiner recorded the Schiff Index score corresponding to the response to the air challenge. The Schiff Index Sensitivity scale is scored as follows- 0: tooth/subject did not respond to stimulus, 1: tooth/subject responds to stimulus, but does not request discontinuation of stimulus, 2: tooth/subject responds to stimulus and requests discontinuation or moves form stimulus, 3: tooth/subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A negative change from Baseline score represents a decrease in sensitivity from baseline.The mean change from Baseline was calculated for this measure.
Time frame: Within 5 minutes after treatment was applied
Change From Baseline Visual Analog Scale
Visual Analog Scale (VAS) - subjects are asked to look at a VAS and designate the level of hypersensitivity they experienced as a result of the thermal and water challenges using a continuum scale of 0 = No tooth pain up to 100 = Worst tooth pain ever experienced. A negative change from Baseline score represents a decrease in sensitivity from baseline.
Time frame: Within 5 minutes after treatment was applied
| Milestone | Super Seal® Desensitizer | Acclean® Fluoride Varnish |
|---|---|---|
| Started | 11 | 11 |
| Completed | 11 | 11 |
| Not completed | 0 | 0 |
The Schiff Sensitivity Scale was assessed for each test tooth via an evaporative air challenge. The examiner recorded the Schiff Index score corresponding to the response to the air challenge. The Schiff Index Sensitivity scale is scored as follows- 0: tooth/subject did not respond to stimulus, 1: tooth/subject responds to stimulus, but does not request discontinuation of stimulus, 2: tooth/subject responds to stimulus and requests discontinuation or moves form stimulus, 3: tooth/subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A negative change from Baseline score represents a decrease in sensitivity from baseline.The mean change from Baseline was calculated for this measure.
| Units on a scale | Super Seal® Desensitizer | Acclean® Fluoride Varnish |
|---|---|---|
| Change From Baseline Air Challenge | -0.55 ± 0.69 | -0.95 ± 0.93 |
Visual Analog Scale (VAS) - subjects are asked to look at a VAS and designate the level of hypersensitivity they experienced as a result of the thermal and water challenges using a continuum scale of 0 = No tooth pain up to 100 = Worst tooth pain ever experienced. A negative change from Baseline score represents a decrease in sensitivity from baseline.
| Units on a scale | Super Seal® Desensitizer | Acclean® Fluoride Varnish |
|---|---|---|
| Change From Baseline Visual Analog Scale | -17.60 ± 21.32 | -19.55 ± 25.15 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Super Seal® Desensitizer | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) |
| Acclean® Fluoride Varnish | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) |
| Age, Categorical(Participants) | Super Seal® Desensitizer | Acclean® Fluoride Varnish | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 11 | 11 | 22 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Super Seal® Desensitizer | Acclean® Fluoride Varnish | Total |
|---|---|---|---|
| Mean | 44.6 ± 9.84 | 48.1 ± 19.71 | 46.4 ± 15.30 |
| Sex: Female, Male(Participants) | Super Seal® Desensitizer | Acclean® Fluoride Varnish | Total |
|---|---|---|---|
| Female | 9 | 11 | 20 |
| Male | 2 | 0 | 2 |
| Race/Ethnicity, Customized(Participants) | Super Seal® Desensitizer | Acclean® Fluoride Varnish | Total |
|---|---|---|---|
| Asian Oriental | 1 | 1 | 2 |
| Black | 0 | 1 | 1 |
| Caucasian | 8 | 9 | 17 |
| Hispanic | 2 | 0 | 2 |
| Region of Enrollment(participants) | Super Seal® Desensitizer | Acclean® Fluoride Varnish | Total |
|---|---|---|---|
| United States | 11 | 11 | 22 |
No study locations are listed for this record.
This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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Procter and Gamble