Dentin Sensitivity
Conditions
Keywords
Sensitivity
Brief summary
This study will compare the safety and effectiveness of two water-based potassium oxalate desensitizers on existing dentinal hypersensitivity.
Interventions
DEVICEPotassium oxalate
Professional application
Sponsors
Procter and Gamble
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Provide written informed consent to participate in the study * Be at least 18 years of age * Be in good general health, as determined by the Investigator/designee based on review of the health history/update for participation in the study * Agree to refrain from participating in any other oral/dental product studies for the duration of the study * Agree to refrain from receiving any elective dentistry (including dental prophylaxis) for the duration of the study * Agree to refrain from using any oral hygiene products other than the assigned study products for the duration of the study * Agree to comply with study/product usage instructions; and * Have at least one tooth with gingival recession and hypersensitivity evidenced by a score of ≥ 1 on the Cold Air Sensitivity Schiff scale during screening
Exclusion criteria
* Gross oral neglect or urgent dental treatment needs * Severe periodontal disease and/or generalized mobility * Active treatment for periodontitis * Any disease or condition that could be expected to interfere with examination procedures or safe completion of the study * Self-reported pregnancy or nursing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline for Air Challenge | 36 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 Dentin Sensitivity | 36 days | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Potassium Oxalate Gel Professional application
Potassium oxalate: Professional application | 45 |
| Potassium Oxalate Liquid Professional application
Potassium oxalate: Professional application | 35 |
| Total | 80 |
Baseline characteristics
| Characteristic | Potassium Oxalate Liquid | Total | Potassium Oxalate Gel |
|---|---|---|---|
| Age, Continuous | 45.7 years STANDARD_DEVIATION 13.72 | 46.3 years STANDARD_DEVIATION 13.39 | 46.7 years STANDARD_DEVIATION 13.26 |
| Race/Ethnicity, Customized Ethnicity Asian Indian | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Ethnicity Asian Oriental | 4 Participants | 9 Participants | 5 Participants |
| Race/Ethnicity, Customized Ethnicity Black | 11 Participants | 21 Participants | 10 Participants |
| Race/Ethnicity, Customized Ethnicity Caucasian | 16 Participants | 38 Participants | 22 Participants |
| Race/Ethnicity, Customized Ethnicity Hispanic | 3 Participants | 8 Participants | 5 Participants |
| Race/Ethnicity, Customized Ethnicity Multi-Racial | 1 Participants | 2 Participants | 1 Participants |
| Sex: Female, Male Female | 20 Participants | 43 Participants | 23 Participants |
| Sex: Female, Male Male | 15 Participants | 37 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 45 | 0 / 35 |
| other Total, other adverse events | 2 / 45 | 1 / 35 |
| serious Total, serious adverse events | 0 / 45 | 0 / 35 |
Outcome results
Primary
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. The higher the Schiff score, the more sensitive the tooth. The mean change from Baseline was calculated for this measure.
Time frame: 36 days
Population: Eighty (80) subjects received study products. Seventy-eight (78) subjects completed the study. Two subjects dropped from the study after the Day 6 visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Potassium Oxalate Gel | Change From Baseline for Air Challenge | -1.18 units on a scale | Standard Error 0.46 |
| Potassium Oxalate Liquid | Change From Baseline for Air Challenge | -1.10 units on a scale | Standard Error 0.56 |
Secondary
Change From Baseline in Dentin Sensitivity
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.
Time frame: 36 days
Population: Eighty (80) subjects received product. Seventy-eight (78) subjects completed the study. Two subjects dropped from the study after the Day 6 visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Potassium Oxalate Gel | Change From Baseline in Dentin Sensitivity | Schiff Air Index | -1.18 untis on a scale | Standard Error 0.46 |
| Potassium Oxalate Gel | Change From Baseline in Dentin Sensitivity | Visual Analog Scale | -27.18 untis on a scale | Standard Error 21.1 |
| Potassium Oxalate Liquid | Change From Baseline in Dentin Sensitivity | Schiff Air Index | -1.10 untis on a scale | Standard Error 0.56 |
| Potassium Oxalate Liquid | Change From Baseline in Dentin Sensitivity | Visual Analog Scale | -30.57 untis on a scale | Standard Error 18.16 |