Dentin Sensitivity
Conditions
Brief summary
This study will assess sensitivity during a dental prophylaxis with or without the use of a potassium oxalate salt solution.
Interventions
DEVICEOxalate Salt Solution
Applied by dentist
Sponsors
Procter and Gamble
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
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, 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 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
* 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 orthodontic appliances
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline Air Challenge | 10 Minutes | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline for Yeaple Probe | 10 Minutes | 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 |
|---|---|
| Oxalate Salt Solution Professionally applied
Oxalate Salt Solution: Applied by dentist | 17 |
| No Treatment No Treatment | 19 |
| Total | 36 |
Baseline characteristics
| Characteristic | Total | Oxalate Salt Solution | No Treatment |
|---|---|---|---|
| Age, Continuous | 34.5 years STANDARD_DEVIATION 12 | 34.5 years STANDARD_DEVIATION 14.14 | 34.5 years STANDARD_DEVIATION 10.11 |
| Race/Ethnicity, Customized Ethnicity Asian Oriental | 6 Participants | 4 Participants | 2 Participants |
| Race/Ethnicity, Customized Ethnicity Black | 5 Participants | 1 Participants | 4 Participants |
| Race/Ethnicity, Customized Ethnicity Caucasian | 14 Participants | 6 Participants | 8 Participants |
| Race/Ethnicity, Customized Ethnicity Hispanic | 6 Participants | 4 Participants | 2 Participants |
| Race/Ethnicity, Customized Ethnicity Multi-Racial | 5 Participants | 2 Participants | 3 Participants |
| Region of Enrollment United States | 36 participants | 17 participants | 19 participants |
| Sex: Female, Male Female | 19 Participants | 9 Participants | 10 Participants |
| Sex: Female, Male Male | 17 Participants | 8 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 19 |
| other Total, other adverse events | 0 / 17 | 0 / 19 |
| serious Total, serious adverse events | 0 / 17 | 0 / 17 |
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: 10 Minutes
Population: Thirty-Six (36) subjects received products. Thirty-Six (36) subjects completed the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oxalate Salt Solution | Change From Baseline Air Challenge | -0.412 Units on a scale | Standard Deviation 0.537 |
| No Treatment | Change From Baseline Air Challenge | -0.132 Units on a scale | Standard Deviation 0.403 |
Secondary
Change From Baseline for Yeaple Probe
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: 10 Minutes
Population: Thirty-six (36) subjects received study products. Thirty-six (36) subjects completed the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oxalate Salt Solution | Change From Baseline for Yeaple Probe | 10.000 Units on a scale | Standard Deviation 8.101 |
| No Treatment | Change From Baseline for Yeaple Probe | 1.316 Units on a scale | Standard Deviation 6.634 |