Dentinal Hypersensitivity
Conditions
Brief summary
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.
Interventions
DEVICESuper Seal® Desensitizer
Single dose professional application.
DEVICEAcclean® Fluoride Varnish
Single dose professional application.
Sponsors
Procter and Gamble
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* be at least 18 years of age; * provide written informed consent prior to participation and be given a signed copy of the informed consent form; * be in good general health as determined by the Investigator/designee; and * have at least one tooth with a VAS score of greater than or equal to 30 in response to the air challenge.
Exclusion criteria
* allergy to rosin or to pine nuts; * self-reported pregnancy or nursing; * severe periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession; * active treatment for periodontitis; * fixed facial orthodontic appliances; * any diseases or conditions that might interfere with the safe completion of the study; or * an inability to undergo any study procedures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline Air Challenge | Within 5 minutes after treatment was applied | 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. |
| Change From Baseline Visual Analog Scale | Within 5 minutes after treatment was applied | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Super Seal® Desensitizer Professionally Applied
Super Seal® Desensitizer: Single dose professional application. | 11 |
| Acclean® Fluoride Varnish Professionally Applied
Acclean® Fluoride Varnish: Single dose professional application. | 11 |
| Total | 22 |
Baseline characteristics
| Characteristic | Super Seal® Desensitizer | Acclean® Fluoride Varnish | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants | 11 Participants | 22 Participants |
| Age, Continuous | 44.6 years STANDARD_DEVIATION 9.84 | 48.1 years STANDARD_DEVIATION 19.71 | 46.4 years STANDARD_DEVIATION 15.3 |
| Race/Ethnicity, Customized Asian Oriental | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Black | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Caucasian | 8 Participants | 9 Participants | 17 Participants |
| Race/Ethnicity, Customized Hispanic | 2 Participants | 0 Participants | 2 Participants |
| Region of Enrollment United States | 11 participants | 11 participants | 22 participants |
| Sex: Female, Male Female | 9 Participants | 11 Participants | 20 Participants |
| Sex: Female, Male Male | 2 Participants | 0 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 11 |
| other Total, other adverse events | 0 / 11 | 0 / 11 |
| serious Total, serious adverse events | 0 / 11 | 0 / 11 |
Outcome results
Primary
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
Population: Twenty-two (22) subjects received study product and completed the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Super Seal® Desensitizer | Change From Baseline Air Challenge | -0.55 Units on a scale | Standard Deviation 0.69 |
| Acclean® Fluoride Varnish | Change From Baseline Air Challenge | -0.95 Units on a scale | Standard Deviation 0.93 |
Primary
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
Population: Twenty-two (22) subjects received product and completed the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Super Seal® Desensitizer | Change From Baseline Visual Analog Scale | -17.60 Units on a scale | Standard Deviation 21.32 |
| Acclean® Fluoride Varnish | Change From Baseline Visual Analog Scale | -19.55 Units on a scale | Standard Deviation 25.15 |