Dentin Sensitivity
Conditions
Keywords
Sensitivity
Brief summary
This pilot study will evaluate the safety and effectiveness of a marketed sensitivity strip on existing dentinal hypersensitivity compared to a marketed sensitivity pen.
Interventions
DEVICEColgate® Sensitivity Relief Pen
Sponsors
Procter and Gamble
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* be at least 18 years of age * sign an informed consent form and be given a copy * be in good general health as determined by the Investigator/designee * agree to delay any elective dentistry, including dental prophylaxis, and to report any dentistry received during the course of the study * agree to not participate in any other oral care study for the duration of this study * agree to return for scheduled visits and follow all study procedures * have dentinal hypersensitivity with at least one tooth with a Schiff sensitivity score of at least 1 in response to the cold water challenge
Exclusion criteria
* severe periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession * active treatment for periodontitis * any diseases or conditions that might interfere with the subject safely completing the study * inability to undergo study procedures * fixed facial orthodontic appliances * a history of kidney stones * self-reported pregnancy or nursing * known allergies to the following ingredients; aqua, glycerin, cellulose gum, dipotassium oxalate, carbomer, sodium hydroxide, sodium benzoate, and potassium sorbate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline Visual Analog Scale | 1 Day | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline for Air Challenge | 1 Day | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Crest® Sensi-Stop™ Strips Professionally Applied
Crest® Sensi-Stop™ Strips | 15 |
| Colgate® Sensitivity Relief Pen Professionally Applied
Colgate® Sensitivity Relief Pen | 15 |
| Total | 30 |
Baseline characteristics
| Characteristic | Crest® Sensi-Stop™ Strips | Colgate® Sensitivity Relief Pen | 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 | 15 Participants | 15 Participants | 30 Participants |
| Age, Continuous | 43.2 years STANDARD_DEVIATION 7.97 | 43.5 years STANDARD_DEVIATION 7.77 | 43.4 years STANDARD_DEVIATION 7.73 |
| Race/Ethnicity, Customized Asian Oriental | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Black | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Caucasian | 14 Participants | 13 Participants | 27 Participants |
| Region of Enrollment United States | 15 participants | 15 participants | 30 participants |
| Sex: Female, Male Female | 6 Participants | 10 Participants | 16 Participants |
| Sex: Female, Male Male | 9 Participants | 5 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 2 / 15 | 1 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
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: 1 Day
Population: Thirty (30) subjects received study products and completed the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crest® Sensi-Stop™ Strips | Change From Baseline Visual Analog Scale | -22.933 Units on a scale | Standard Deviation 19.252 |
| Colgate® Sensitivity Relief Pen | Change From Baseline Visual Analog Scale | -3.200 Units on a scale | Standard Deviation 11.857 |
Secondary
Change From Baseline for 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: 1 Day
Population: Thirty (30) subjects received study product and completed the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crest® Sensi-Stop™ Strips | Change From Baseline for Air Challenge | -0.800 Units on a scale | Standard Deviation 0.561 |
| Colgate® Sensitivity Relief Pen | Change From Baseline for Air Challenge | 0.000 Units on a scale | Standard Deviation 0.378 |