Dentin Sensitivity
Conditions
Keywords
Sensitivity
Brief summary
This study will compare the safety and effectiveness of a potassium oxalate desensitizer or negative control on dentinal hypersensitivity.
Interventions
DEVICEPotassium Oxalate
OTHERWater
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; * complete a confidentiality disclosure agreement; * be in good general health as determined by the Investigator/designee; * agree not to participate in any other oral/dental product studies during the course of this study; * agree to delay any dentistry (including dental prophylaxis) until the study has been completed; * agree to refrain from the use of any non-study oral hygiene products; * agree to return for all scheduled visits and follow study procedures; and. * have at least one tooth with a Schiff sensitivity score of at least 1 in response to air challenge and a Yeaple Probe score of 10-40 in response to tactile challenge
Exclusion criteria
* self-reported pregnancy or nursing; * severe periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession; * active treatment of periodontitis; * fixed facial orthodontic appliances; * 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 * 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 | 30 days | 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. The higher the Schiff score, the more sensitive the tooth. The mean change from Baseline was calculated for this measure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Tactile Threshold | 30 days | Tactile Threshold was measured using a Yeaple probe. Testing was performed beginning at 10 g. The examiner recorded tactile scores for responding teeth. After treatment, testing began at 10 g and increase by 10 g to a maximum of 50 g. The higher the tactile threshold, the less sensitive the tooth. Each successive challenge increased until a yes response was repeated. If a second yes was not obtained, the force setting was increased to the next step and continued until a force was found which elicited two consecutive yes responses and was recorded as the threshold on the Tactile Sensitivity Score form. The mean change from Baseline was calculated for this measure. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Potassium Oxalate Gel Self Applied
Potassium Oxalate | 35 |
| Water Self Applied
Water | 35 |
| Total | 70 |
Baseline characteristics
| Characteristic | Water | Total | Potassium Oxalate Gel |
|---|---|---|---|
| Age, Continuous | 36.6 years STANDARD_DEVIATION 14.25 | 35.6 years STANDARD_DEVIATION 12.74 | 34.5 years STANDARD_DEVIATION 11.13 |
| Race/Ethnicity, Customized Ethnicity Asian Indian | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Ethnicity Asian Oriental | 1 Participants | 3 Participants | 2 Participants |
| Race/Ethnicity, Customized Ethnicity Black | 10 Participants | 20 Participants | 10 Participants |
| Race/Ethnicity, Customized Ethnicity Caucasian | 14 Participants | 26 Participants | 12 Participants |
| Race/Ethnicity, Customized Ethnicity Hispanic | 6 Participants | 15 Participants | 9 Participants |
| Race/Ethnicity, Customized Ethnicity Multi-Racial | 3 Participants | 5 Participants | 2 Participants |
| Sex: Female, Male Female | 22 Participants | 42 Participants | 20 Participants |
| Sex: Female, Male Male | 13 Participants | 28 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 35 | 0 / 35 |
| other Total, other adverse events | 0 / 35 | 0 / 35 |
| serious Total, serious adverse events | 0 / 35 | 0 / 35 |
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. The higher the Schiff score, the more sensitive the tooth. The mean change from Baseline was calculated for this measure.
Time frame: 30 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Potassium Oxalate Gel | Change From Baseline Air Challenge | -1.200 units on a scale | Standard Deviation 0.677 |
| Water | Change From Baseline Air Challenge | -0.086 units on a scale | Standard Deviation 0.284 |
Secondary
Change From Baseline in Tactile Threshold
Tactile Threshold was measured using a Yeaple probe. Testing was performed beginning at 10 g. The examiner recorded tactile scores for responding teeth. After treatment, testing began at 10 g and increase by 10 g to a maximum of 50 g. The higher the tactile threshold, the less sensitive the tooth. Each successive challenge increased until a yes response was repeated. If a second yes was not obtained, the force setting was increased to the next step and continued until a force was found which elicited two consecutive yes responses and was recorded as the threshold on the Tactile Sensitivity Score form. The mean change from Baseline was calculated for this measure.
Time frame: 30 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Potassium Oxalate Gel | Change From Baseline in Tactile Threshold | 16.857 Grams (g) | Standard Deviation 12.312 |
| Water | Change From Baseline in Tactile Threshold | 0.286 Grams (g) | Standard Deviation 2.956 |