Hypersensitivity
Conditions
Brief summary
The objective of this study is to evaluate the clinical efficacy of a prophylaxis paste containing 10% arginine bicarbonate on dentinal hypersensitivity reduction when applied as a pre-procedure to a professional dental cleaning.
Interventions
One time treatment
DEVICENupro - Fluoride Free
Brush twice daily
Sponsors
Colgate Palmolive
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Male and female subjects, ages 18-70, inclusive. * Availability for the three (3) week duration of the study. * Two (2) sensitive teeth, which must be anterior to the molars, and demonstrate cervical erosion/abrasion or gingival recession. * Qualifying response to tactile stimuli (Yeaple probe) as defined by a score between 10-50gms. of force. * Qualifying response to the air blast stimuli as defined by a score of 2 or 3 on the Schiff Cold Air Sensitivity Scale. * Subjects need to satisfy the qualifying response to stimuli for both the parameters assessed (tactile or air) on two teeth to be entered into the study. * Good general health with no known allergies to products being tested. * Use of a non-desensitizing dentifrice for three months prior to entry into the study. * Signed Informed Consent Form.
Exclusion criteria
* Gross oral pathology, chronic disease, or history of allergy to test products. * Advanced periodontal disease or treatment for periodontal disease (including surgery) within the past twelve months. * Scheduled dental prophylaxis within three weeks prior to the Baseline Hypersensitivity Examination. * Sensitive teeth with mobility greater than one. * Teeth with extensive/defective restorations (including prosthetic crowns), suspected pulpitis, caries, cracked enamel, or used as abutments for removable partial dentures. * Subjects that began to take anticonvulsants, antihistamines, antidepressants, sedatives, tranquilizers, anti-inflammatory drugs, or daily analgesics within one month prior to the start of the study or who have to start taking these during the course of the study. * Participation in a desensitizing dentifrice study or regular use of a desensitizing dentifrice within the past three months. * Current participation in any other clinical study. * Pregnant or lactating subjects. * Allergies to oral care products, personal care consumer products, or their ingredients. * Medical condition which prohibits not eating/drinking for 4 hours.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hypersensitivity to Touch (Tactile) | Immediately after product application | Units on a scale: Measured with an electronic force sensing probe (Yeaple Probe): 10, 20, 30, 40, up to 50 grams of force are applied to hypersensitive tooth until pain elicited. Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. The higher the score, the higher the hypersensitivity. |
| Air Blast | Immediately after product application | Units on a scale using Schiff Cold Air Sensitivity Scale. Response to a constant (duration, pressure, temperature, distance from target) jet of air applied to a hypersensitive tooth. According to this analog scale hypersensitivity scores for the stimulated tooth is 0, 1, 2 or 3(The lower the score, the lower the hypersensitivity). 0=No subject response to stimulus, 1=responds but will continue, 2=responds and moves or requests discontinuation, 3=Painful response to stimulus, discontinuation requested. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ProClude Prophylaxis Paste-A Arginine Bicarbonate prophy paste (experimental). | 22 |
| Nupro-M Prophylaxis Paste-B Control prophy paste (Fluoride free). | 23 |
| Total | 45 |
Baseline characteristics
| Characteristic | Nupro-M Prophylaxis Paste-B | ProClude Prophylaxis Paste-A | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 23 Participants | 21 Participants | 44 Participants |
| Age Continuous | 45.91 years STANDARD_DEVIATION 11.41 | 44.13 years STANDARD_DEVIATION 7.78 | 45 years STANDARD_DEVIATION 9.66 |
| Region of Enrollment United States | 23 participants | 22 participants | 45 participants |
| Sex: Female, Male Female | 17 Participants | 16 Participants | 33 Participants |
| Sex: Female, Male Male | 6 Participants | 6 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 22 | 0 / 23 |
| serious Total, serious adverse events | 0 / 22 | 0 / 23 |
Outcome results
Primary
Air Blast
Units on a scale using Schiff Cold Air Sensitivity Scale. Response to a constant (duration, pressure, temperature, distance from target) jet of air applied to a hypersensitive tooth. According to this analog scale hypersensitivity scores for the stimulated tooth is 0, 1, 2 or 3(The lower the score, the lower the hypersensitivity). 0=No subject response to stimulus, 1=responds but will continue, 2=responds and moves or requests discontinuation, 3=Painful response to stimulus, discontinuation requested.
Time frame: Immediately after product application
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ProClude Prophylaxis Paste-A | Air Blast | 1.26 Units on a scale | Standard Deviation 0.58 |
| Nupro-M Prophylaxis Paste-B | Air Blast | 2.17 Units on a scale | Standard Deviation 0.58 |
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA
Primary
Hypersensitivity to Touch (Tactile)
Units on a scale: Measured with an electronic force sensing probe (Yeaple Probe): 10, 20, 30, 40, up to 50 grams of force are applied to hypersensitive tooth until pain elicited. Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. The higher the score, the higher the hypersensitivity.
Time frame: Immediately after product application
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ProClude Prophylaxis Paste-A | Hypersensitivity to Touch (Tactile) | 42.2 Units on a scale | Standard Deviation 9.25 |
| Nupro-M Prophylaxis Paste-B | Hypersensitivity to Touch (Tactile) | 20.1 Units on a scale | Standard Deviation 9.25 |
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA