Dentin Sensitivity
Conditions
Keywords
Sensitivity
Brief summary
This study will compare the safety and effectiveness of a potassium oxalate desensitizer on adjacent teeth with dentinal hypersensitivity.
Interventions
Sponsors
Procter and Gamble
Study design
Allocation
NA
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 * have at least one pair of adjacent teeth, each of which has a screening score of - -greater than or equal to 1 on the Schiff Sensitivity Scale 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 * self-reported pregnancy or nursing * a history of kidney stones * 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 Cold Water Challenge | 1 Day | The Schiff Sensitivity Scale was assessed for each test tooth via a cold water challenge. The examiner recorded the Schiff Index score corresponding to the response to the cold water 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. |
Secondary
| 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. The mean change from Baseline was calculated for this measure. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Crest® Sensi-Stop™ Strips Self Applied
Crest® Sensi-Stop™ Strips | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | Crest® Sensi-Stop™ Strips |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants |
| Age, Continuous | 42.9 years STANDARD_DEVIATION 8.61 |
| Race/Ethnicity, Customized Ethnicity Black | 1 Participants |
| Race/Ethnicity, Customized Ethnicity Caucasian | 12 Participants |
| Race/Ethnicity, Customized Ethnicity Hispanic | 2 Participants |
| Region of Enrollment United States | 15 Participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 15 |
| other Total, other adverse events | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 |
Outcome results
Primary
Change From Baseline Cold Water Challenge
The Schiff Sensitivity Scale was assessed for each test tooth via a cold water challenge. The examiner recorded the Schiff Index score corresponding to the response to the cold water 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: Fifteen (15) subjects received study products. Fifteen (15) subjects completed the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crest® Sensi-Stop™ Strips | Change From Baseline Cold Water Challenge | -1.00 Units on a scale | Standard Deviation 0.76 |
Secondary
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. The mean change from Baseline was calculated for this measure.
Time frame: 1 Day
Population: Fifteen (15) subjects received study products. Fifteen (15) subjects completed the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crest® Sensi-Stop™ Strips | Change From Baseline Visual Analog Scale | -18.00 Units on a scale | Standard Deviation 13.61 |