Dentin Sensitivity
Conditions
Keywords
Sensitivity
Brief summary
This study will determine the effects toothbrush type (power or manual) has on the safety and effectiveness of professional dentinal hypersensitivity treatment with a marketed oxalate-containing solution.
Interventions
DEVICEPotassium Oxalate
Professionally applied liquid
SnF2 Paste
DEVICEManual toothbrush
Marketed manual toothbrush
DEVICEPower toothbrush
Marketed power toothbrush
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 photography consent agreement pertaining to the collection and use of non-identifying intraoral photographs; * be in good general health as determined by the Investigator/designee; and * have at least one tooth with a Schiff sensitivity score of at least 1 in response to the cool air 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; * 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 Visual Analog Scale | 30 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 |
|---|---|
| Oxalate Liquid, SnF2 Paste, Manual Toothbrush Potassium oxalate liquid, professionally applied Stannous fluoride paste, self applied Manual toothbrush
Potassium Oxalate: Professionally applied liquid
Stannous fluoride paste: SnF2 Paste
Manual toothbrush: Marketed manual toothbrush | 12 |
| Oxalate Liquid, SnF2 Paste, Power Toothbrush Potassium oxalate liquid, professionally applied Stannous fluoride paste, self applied Power toothbrush
Potassium Oxalate: Professionally applied liquid
Stannous fluoride paste: SnF2 Paste
Power toothbrush: Marketed power toothbrush | 12 |
| Total | 24 |
Baseline characteristics
| Characteristic | Oxalate Liquid, SnF2 Paste, Manual Toothbrush | Oxalate Liquid, SnF2 Paste, Power Toothbrush | 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 | 12 Participants | 12 Participants | 24 Participants |
| Age, Continuous | 42.6 years STANDARD_DEVIATION 14.74 | 46.7 years STANDARD_DEVIATION 9.63 | 44.6 years STANDARD_DEVIATION 12.36 |
| Race/Ethnicity, Customized Ethnicity Asian Oriental | 2 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Ethnicity Black | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Ethnicity Caucasian | 7 Participants | 8 Participants | 15 Participants |
| Race/Ethnicity, Customized Ethnicity Hispanic | 1 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized Ethnicity Multi-Racial | 1 Participants | 1 Participants | 2 Participants |
| Region of Enrollment United States | 12 participants | 12 participants | 24 participants |
| Sex: Female, Male Female | 10 Participants | 12 Participants | 22 Participants |
| Sex: Female, Male Male | 2 Participants | 0 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 12 |
| other Total, other adverse events | 0 / 12 | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 |
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 |
|---|---|---|---|
| Oxalate Liquid, SnF2 Paste, Manual Toothbrush | Change From Baseline Air Challenge | -0.409 Units on a scale | Standard Deviation 0.701 |
| Oxalate Liquid, SnF2 Paste, Power Toothbrush | Change From Baseline Air Challenge | -0.917 Units on a scale | Standard Deviation 0.733 |
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.
Time frame: 30 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oxalate Liquid, SnF2 Paste, Manual Toothbrush | Change From Baseline Visual Analog Scale | -11.000 Units on a scale | Standard Deviation 12.929 |
| Oxalate Liquid, SnF2 Paste, Power Toothbrush | Change From Baseline Visual Analog Scale | -28.500 Units on a scale | Standard Deviation 21.075 |