Dentin Sensitivity
Conditions
Keywords
Sensitivity
Brief summary
This study will compare the safety and effectiveness of normal oral hygiene with two different marketed dentifrices, on longer term dentinal hypersensitivity response following use of potassium oxalate desensitizers.
Interventions
DEVICEPotassium oxalate
Professionally applied (liquid) and self applied (gel)
DRUGSodium fluoride paste
Toothpaste used by subject
Toothpaste used by subject
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
* 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 * Have at least one tooth with a Schiff sensitivity score of at least 1 in response to the 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 * 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 * An inability to undergo any study procedures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline Air Challenge | 60 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/subjects responds to stimulus and requests discontinuation or moves from 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 | 60 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 & Gel Plus SnF2 Paste Potassium oxalate liquid, professionally applied Potassium oxalate gel, self applied Stannous fluoride paste, self applied
Potassium oxalate: Professionally applied (liquid) and self applied (gel)
Stannous fluoride paste: Toothpaste used by subject | 15 |
| Oxalate Liquid & Gel Plus NaF Paste Potassium oxalate liquid, professionally applied Potassium oxalate gel, self applied Sodium fluoride paste, self applied
Potassium oxalate: Professionally applied (liquid) and self applied (gel)
Sodium fluoride paste: Toothpaste used by subject | 15 |
| Total | 30 |
Baseline characteristics
| Characteristic | Total | Oxalate Liquid & Gel Plus NaF Paste | Oxalate Liquid & Gel Plus SnF2 Paste |
|---|---|---|---|
| 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 | 30 Participants | 15 Participants | 15 Participants |
| Age, Continuous | 43.2 years STANDARD_DEVIATION 11.69 | 44.9 years STANDARD_DEVIATION 12.52 | 41.5 years STANDARD_DEVIATION 10.97 |
| Race/Ethnicity, Customized American Indian | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian Oriental | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Black | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Caucasian | 21 Participants | 11 Participants | 10 Participants |
| Race/Ethnicity, Customized Hispanic | 3 Participants | 2 Participants | 1 Participants |
| Race/Ethnicity, Customized Multi-Racial | 1 Participants | 1 Participants | 0 Participants |
| Sex: Female, Male Female | 28 Participants | 14 Participants | 14 Participants |
| Sex: Female, Male Male | 2 Participants | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 14 | 0 / 15 |
| other Total, other adverse events | 1 / 14 | 0 / 15 |
| serious Total, serious adverse events | 0 / 14 | 0 / 15 |
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/subjects responds to stimulus and requests discontinuation or moves from 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: 60 days
Population: Thirty (30) subjects received study products and were measured at the Baseline visit. Twenty-Nine (29) subjects completed the study thus, one subject dropped from the study prior to Day 60 and was not analyzed for the 60 day measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oxalate Liquid & Gel Plus SnF2 Paste | Change From Baseline Air Challenge | -1.643 Units on a scale | Standard Deviation 0.77 |
| Oxalate Liquid & Gel Plus NaF Paste | Change From Baseline Air Challenge | -1.500 Units on a scale | Standard Deviation 0.906 |
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: 60 days
Population: Thirty (30) subjects received study products. Twenty-Nine (29) subjects completed the study thus, one subject dropped from the study prior to Day 60 and was not analyzed for the 60 day measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oxalate Liquid & Gel Plus SnF2 Paste | Change From Baseline Visual Analog Scale | -29.82 Units on a scale | Standard Deviation 18.65 |
| Oxalate Liquid & Gel Plus NaF Paste | Change From Baseline Visual Analog Scale | -24.67 Units on a scale | Standard Deviation 26.75 |