Dentinal Hypersensitivity
Conditions
Brief summary
This study will assess the oral tolerability and immediate post-treatment safety of topical application for two marketed oxalate products as initial care in dental patients to treat or prevent tooth sensitivity pain that may be attributed to dentinal hypersensitivity.
Interventions
DEVICEPotassium Oxalate Gel
Self applied
DEVICEPotassium Oxalate Liquid
Professionally Applied
SnF2 Paste
Sponsors
Procter and Gamble
Study design
Allocation
NON_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 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 at risk for hypersensitivity.
Exclusion criteria
* any medical condition requiring pre-medication prior to dental procedures * any diseases or conditions that might interfere with the subject safely completing the study * inability to undergo study procedures * a history of kidney stones * have self-reported pregnancy or nursing * known allergies to the following ingredients; aqua, glycerin, cellulose gum, dipotassium oxalate, carbomer, sodium hydroxide, sodium benzoate, or potassium sorbate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| How Satisfied Were Participants With Treatment? | up to 8 weeks | Questionnaire indicating the frequencies of using various oral hygiene products by subjects at 5 different dental practices. |
| Ease of Treatment at Home | Up to 8 weeks | Questionnaire indicating the frequencies of using various oral hygiene products by subjects at 5 different dental practices. |
| Did Participants Notice a Difference in the Areas Noted? | Up to 8 weeks | Questionnaire indicating the frequencies of using various oral hygiene products by subjects at 5 different dental practices. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Potassium Oxalate Gel potassium oxalate gel self applied
Potassium Oxalate Gel: Self applied | 57 |
| Oxalate Liquid, SnF2 Paste Potassium oxalate liquid professionally applied, Stannous fluoride paste self applied
Potassium Oxalate Liquid: Professionally Applied
Stannous fluoride paste: SnF2 Paste | 47 |
| Total | 104 |
Baseline characteristics
| Characteristic | Potassium Oxalate Gel | Oxalate Liquid, SnF2 Paste | Total |
|---|---|---|---|
| Age, Continuous | 41.8 years STANDARD_DEVIATION 11.99 | 45.8 years STANDARD_DEVIATION 12.91 | 43.6 years STANDARD_DEVIATION 12.51 |
| Region of Enrollment United States | 57 participants | 47 participants | 104 participants |
| Sex: Female, Male Female | 41 Participants | 35 Participants | 76 Participants |
| Sex: Female, Male Male | 16 Participants | 12 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 57 | 0 / 47 |
| serious Total, serious adverse events | 0 / 57 | 0 / 47 |
Outcome results
Primary
Did Participants Notice a Difference in the Areas Noted?
Questionnaire indicating the frequencies of using various oral hygiene products by subjects at 5 different dental practices.
Time frame: Up to 8 weeks
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Potassium Oxalate Gel | Did Participants Notice a Difference in the Areas Noted? | Hot/Cold | Yes | 42 Participants |
| Potassium Oxalate Gel | Did Participants Notice a Difference in the Areas Noted? | Hot/Cold | No | 14 Participants |
| Potassium Oxalate Gel | Did Participants Notice a Difference in the Areas Noted? | Sweet/Sour | Yes | 19 Participants |
| Potassium Oxalate Gel | Did Participants Notice a Difference in the Areas Noted? | Sweet/Sour | No | 37 Participants |
| Potassium Oxalate Gel | Did Participants Notice a Difference in the Areas Noted? | Hard/Soft | Yes | 7 Participants |
| Potassium Oxalate Gel | Did Participants Notice a Difference in the Areas Noted? | Hard/Soft | No | 49 Participants |
| Potassium Oxalate Gel | Did Participants Notice a Difference in the Areas Noted? | Cold Air | Yes | 28 Participants |
| Potassium Oxalate Gel | Did Participants Notice a Difference in the Areas Noted? | Cold Air | No | 28 Participants |
| Potassium Oxalate Gel | Did Participants Notice a Difference in the Areas Noted? | Other | Yes | 8 Participants |
| Potassium Oxalate Gel | Did Participants Notice a Difference in the Areas Noted? | Other | No | 48 Participants |
| Oxalate Liquid, SnF2 Paste | Did Participants Notice a Difference in the Areas Noted? | Cold Air | No | 26 Participants |
| Oxalate Liquid, SnF2 Paste | Did Participants Notice a Difference in the Areas Noted? | Hot/Cold | Yes | 30 Participants |
| Oxalate Liquid, SnF2 Paste | Did Participants Notice a Difference in the Areas Noted? | Hard/Soft | No | 31 Participants |
| Oxalate Liquid, SnF2 Paste | Did Participants Notice a Difference in the Areas Noted? | Hot/Cold | No | 14 Participants |
| Oxalate Liquid, SnF2 Paste | Did Participants Notice a Difference in the Areas Noted? | Other | No | 35 Participants |
| Oxalate Liquid, SnF2 Paste | Did Participants Notice a Difference in the Areas Noted? | Sweet/Sour | Yes | 9 Participants |
| Oxalate Liquid, SnF2 Paste | Did Participants Notice a Difference in the Areas Noted? | Cold Air | Yes | 18 Participants |
| Oxalate Liquid, SnF2 Paste | Did Participants Notice a Difference in the Areas Noted? | Sweet/Sour | No | 35 Participants |
| Oxalate Liquid, SnF2 Paste | Did Participants Notice a Difference in the Areas Noted? | Other | Yes | 9 Participants |
| Oxalate Liquid, SnF2 Paste | Did Participants Notice a Difference in the Areas Noted? | Hard/Soft | Yes | 13 Participants |
Primary
Ease of Treatment at Home
Questionnaire indicating the frequencies of using various oral hygiene products by subjects at 5 different dental practices.
Time frame: Up to 8 weeks
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Potassium Oxalate Gel | Ease of Treatment at Home | Somewhat Difficult to Use | 1 Participants |
| Potassium Oxalate Gel | Ease of Treatment at Home | Somewhat Easy to Use | 24 Participants |
| Potassium Oxalate Gel | Ease of Treatment at Home | Neither Easy Nor Difficult to Use | 2 Participants |
| Potassium Oxalate Gel | Ease of Treatment at Home | Extremely Easy to Use | 29 Participants |
| Potassium Oxalate Gel | Ease of Treatment at Home | Extremely Difficult to Use | 0 Participants |
| Oxalate Liquid, SnF2 Paste | Ease of Treatment at Home | Extremely Easy to Use | 30 Participants |
| Oxalate Liquid, SnF2 Paste | Ease of Treatment at Home | Extremely Difficult to Use | 0 Participants |
| Oxalate Liquid, SnF2 Paste | Ease of Treatment at Home | Somewhat Difficult to Use | 0 Participants |
| Oxalate Liquid, SnF2 Paste | Ease of Treatment at Home | Neither Easy Nor Difficult to Use | 12 Participants |
| Oxalate Liquid, SnF2 Paste | Ease of Treatment at Home | Somewhat Easy to Use | 2 Participants |
Primary
How Satisfied Were Participants With Treatment?
Questionnaire indicating the frequencies of using various oral hygiene products by subjects at 5 different dental practices.
Time frame: up to 8 weeks
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Potassium Oxalate Gel | How Satisfied Were Participants With Treatment? | Very Dissatisfied | 0 Participants |
| Potassium Oxalate Gel | How Satisfied Were Participants With Treatment? | Somewhat Satisfied | 23 Participants |
| Potassium Oxalate Gel | How Satisfied Were Participants With Treatment? | Somewhat Dissatisfied | 2 Participants |
| Potassium Oxalate Gel | How Satisfied Were Participants With Treatment? | Very Satisfied | 24 Participants |
| Potassium Oxalate Gel | How Satisfied Were Participants With Treatment? | Neutral | 7 Participants |
| Oxalate Liquid, SnF2 Paste | How Satisfied Were Participants With Treatment? | Very Satisfied | 20 Participants |
| Oxalate Liquid, SnF2 Paste | How Satisfied Were Participants With Treatment? | Very Dissatisfied | 1 Participants |
| Oxalate Liquid, SnF2 Paste | How Satisfied Were Participants With Treatment? | Neutral | 11 Participants |
| Oxalate Liquid, SnF2 Paste | How Satisfied Were Participants With Treatment? | Somewhat Satisfied | 10 Participants |
| Oxalate Liquid, SnF2 Paste | How Satisfied Were Participants With Treatment? | Somewhat Dissatisfied | 2 Participants |