Tooth Hypersensitivity
Conditions
Brief summary
The study is intended to verify through clinical measurement that the NUPRO Sensodyne Prophylaxis Paste with Novamin provides immediate sensitivity relief as well as extended relief up to 28 days.
Detailed description
It is hypothesized that the prophy paste with NovaMin(r)will give patients immediate sensitivity relief, as well as sensitivity relief up to 4 weeks (28 days) after measurement.
Interventions
DEVICENUPRO Classic Prophy Paste
Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
DEVICENUPRO Sensodyne Prophy Paste with Novamin with fluoride.
Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
DEVICENUPRO Sensodyne Prophy Paste with Novamin without fluoride.
Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
Sponsors
Dentsply International
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Availability to complete in the 28 day duration of the study. * Two sensitive teeth which are not adjacent to each other and preferably in different quadrants and demonstrate cervical erosion, abrasion, and gingival recession. * qualifying response to tactile stimuli as defined by a score of \</= 20 grams. * Qualifying response to air blast stimuli as defined by a score of \>/= 1 on the Schiff Cold Air Sensitivity Scale. * Good general health with no known allergies to products being tested. * Use of a non-desensitizing dentifrice for 3 weeks prior to entry into the study. * Able to follow study procedures and instructions. * Must have a minimum of 10 natural evaluable teeth, excluding 3rd molars.
Exclusion criteria
* Individuals who exhibit gross oral pathology * Females who may be pregnant or lactating or intending to become pregnant * Individuals who require anesthetic during scaling * Dental pathology which may cause pain similar to tooth sensitivity * Individuals with large amounts of calculus * Subjects with active infectious diseases such as hepatitis, HIV or tuberculosis * Any condition requiring antibiotic prophylaxis for dental treatment * Excessive gingival inflammation * Individuals who had their teeth cleaned within 30 days of the screening appointment * Individuals who have had a desensitizing treatment or tooth bleaching within 90 days of screening appointment. * 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. * 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. * Regular use of sedatives, anti-inflammatory drugs, or analgesic * Participation in a desensitizing dentifrice study or regular use of a desensitizing dentifrice within the past 4 weeks. * Current participation in any other clinical study or receipt of an investigational drug within 30 days of the screening visit at the start of the study. * Personnel; a) An employee of the sponsor; b) A member or relative of the study site staff directly involved with the study. * Allergies to oral care products, personal care consumer products, or their ingredients. * Any subject who, in the judgment of the investigator, should not participate in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immediate Sensitivity Relief. Air Blast Sensitivity. | Immediately after treatment. | Sensitivity measurements performed using a cold air blast and sensitivity scored on the four (4) point Schiff scale with 0 equal to no discomfort or awareness of sensitivity and 3 equal to severe pain from sensitive teeth. Score is reported as the change from baseline after treatment. |
| Immediate Sensitivity Relief. Tactile Sensitivity. | Immediately after treatment. | Assessment of sensitivity via tactile stimulation immediately after treatment. Tactile sensitivity measured using a Yeaple probe recording tactile pressure in grams before nerve stimulation. Point of nerve stimulation identified by patient with a yes response as pressure is increased in 10 gram increments. Tactile sensitivity is reported as the change from baseline after treatment. |
| Adverse Events. | Immediately after treatment to 28 days (+/- 2 days) post treatment. | Assessment of adverse events that may occur as a result of treatment (typically includes any kind of allergic reation to paste). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Extended Sensitivity Relief. Tactile Sensitivity. | 28 days (+/- 2 days) post treatment. | Assessment of sensitivity score via tactile stimulation 28 days post treatment. Tactile sensitivity measured using a Yeaple probe recording tactile pressure in grams before nerve stimulation. Point of nerve stimulation identified by patient with yes response as pressure is increased in 10 gram increments. Measured sensitivity is reported as difference from baseline examination. |
| Extended Sensitivity Relief. Air Blast Sensitivity. | 28 days (+/- 2 days) post treatment. | Assessment of cold air sensitivity. Cold air sensitivity measurements performed using a cold air blast and sensitivity scored on the four (4) point Schiff scale with 0 equal to no discomfort or awareness of sensitivity and 3 equal to severe pain from sensitive teeth. |
Countries
United States
Participant flow
Recruitment details
327 subjects queried from Investigator database following IRB apprvoal on 14-Sept.-2011. 199 of the queried subjects were consented and screened. 161 subjects were accepted at screening and appointed for baseline visit 2 weeks later. 159 subjects were evaluated at the baseline exam and 151 subjects were randomized and enrolled into the study.
Pre-assignment details
10 subjects were lost following screening and at baseline assessment. 5 of the 10 were disqualified due to insufficient tactile response, 3 due to lack of evaproative hypersensitivity, and 2 had scheduling conflicts.
Participants by arm
| Arm | Count |
|---|---|
| NUPRO Sensodyne Prophy Paste w/ Novamin NUPRO Sensodyne Prophy Paste with Novamin without fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth. | 52 |
| NUPRO Sensodyne Prophy Paste w/ Novamin(r) w/ Fluoride. NUPRO Sensodyne Prophy Paste with Novamin with fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth. | 49 |
| NUPRO(r) Classic Prophy Paste NUPRO Classic Prophy Paste : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth. | 50 |
| Total | 151 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Scheduling conflict. | 0 | 0 | 2 |
Baseline characteristics
| Characteristic | NUPRO Sensodyne Prophy Paste w/ Novamin(r) w/ Fluoride. | NUPRO(r) Classic Prophy Paste | NUPRO Sensodyne Prophy Paste w/ Novamin | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 49 Participants | 49 Participants | 52 Participants | 150 Participants |
| Age Continuous | 41.55 years STANDARD_DEVIATION 10.7 | 42.10 years STANDARD_DEVIATION 10.31 | 41.31 years STANDARD_DEVIATION 11.1 | 41.65 years STANDARD_DEVIATION 10.65 |
| Region of Enrollment United States | 49 participants | 50 participants | 52 participants | 151 participants |
| Sex: Female, Male Female | 35 Participants | 35 Participants | 37 Participants | 107 Participants |
| Sex: Female, Male Male | 14 Participants | 15 Participants | 15 Participants | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 52 | 0 / 49 | 0 / 50 |
| serious Total, serious adverse events | 0 / 52 | 0 / 49 | 0 / 50 |
Outcome results
Primary
Adverse Events.
Assessment of adverse events that may occur as a result of treatment (typically includes any kind of allergic reation to paste).
Time frame: Immediately after treatment to 28 days (+/- 2 days) post treatment.
Population: Intent to treat (ITT).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NUPRO Sensodyne Prophy Paste w/ Novamin | Adverse Events. | 0 Number of adverse events. |
| NUPRO Sensodyne Prophy Paste w/ Novamin(r) w/ Fluoride. | Adverse Events. | 0 Number of adverse events. |
| NUPRO(r) Classic Prophy Paste | Adverse Events. | 0 Number of adverse events. |
Primary
Immediate Sensitivity Relief. Air Blast Sensitivity.
Sensitivity measurements performed using a cold air blast and sensitivity scored on the four (4) point Schiff scale with 0 equal to no discomfort or awareness of sensitivity and 3 equal to severe pain from sensitive teeth. Score is reported as the change from baseline after treatment.
Time frame: Immediately after treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NUPRO Sensodyne Prophy Paste w/ Novamin | Immediate Sensitivity Relief. Air Blast Sensitivity. | -0.87 units on a scale | Standard Deviation 0.71 |
| NUPRO Sensodyne Prophy Paste w/ Novamin(r) w/ Fluoride. | Immediate Sensitivity Relief. Air Blast Sensitivity. | -0.86 units on a scale | Standard Deviation 0.62 |
| NUPRO(r) Classic Prophy Paste | Immediate Sensitivity Relief. Air Blast Sensitivity. | 0.00 units on a scale | Standard Deviation 0.35 |
Primary
Immediate Sensitivity Relief. Tactile Sensitivity.
Assessment of sensitivity via tactile stimulation immediately after treatment. Tactile sensitivity measured using a Yeaple probe recording tactile pressure in grams before nerve stimulation. Point of nerve stimulation identified by patient with a yes response as pressure is increased in 10 gram increments. Tactile sensitivity is reported as the change from baseline after treatment.
Time frame: Immediately after treatment.
Population: Intention to treat (ITT).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NUPRO Sensodyne Prophy Paste w/ Novamin | Immediate Sensitivity Relief. Tactile Sensitivity. | 12.36 grams | Standard Deviation 12.91 |
| NUPRO Sensodyne Prophy Paste w/ Novamin(r) w/ Fluoride. | Immediate Sensitivity Relief. Tactile Sensitivity. | 10.46 grams | Standard Deviation 12.58 |
| NUPRO(r) Classic Prophy Paste | Immediate Sensitivity Relief. Tactile Sensitivity. | 0.60 grams | Standard Deviation 3.45 |
Secondary
Extended Sensitivity Relief. Air Blast Sensitivity.
Assessment of cold air sensitivity. Cold air sensitivity measurements performed using a cold air blast and sensitivity scored on the four (4) point Schiff scale with 0 equal to no discomfort or awareness of sensitivity and 3 equal to severe pain from sensitive teeth.
Time frame: 28 days (+/- 2 days) post treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NUPRO Sensodyne Prophy Paste w/ Novamin | Extended Sensitivity Relief. Air Blast Sensitivity. | -0.94 units on a scale | Standard Deviation 0.68 |
| NUPRO Sensodyne Prophy Paste w/ Novamin(r) w/ Fluoride. | Extended Sensitivity Relief. Air Blast Sensitivity. | -0.95 units on a scale | Standard Deviation 0.66 |
| NUPRO(r) Classic Prophy Paste | Extended Sensitivity Relief. Air Blast Sensitivity. | 0.03 units on a scale | Standard Deviation 0.47 |
Secondary
Extended Sensitivity Relief. Tactile Sensitivity.
Assessment of sensitivity score via tactile stimulation 28 days post treatment. Tactile sensitivity measured using a Yeaple probe recording tactile pressure in grams before nerve stimulation. Point of nerve stimulation identified by patient with yes response as pressure is increased in 10 gram increments. Measured sensitivity is reported as difference from baseline examination.
Time frame: 28 days (+/- 2 days) post treatment.
Population: Intent to treat (ITT).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NUPRO Sensodyne Prophy Paste w/ Novamin | Extended Sensitivity Relief. Tactile Sensitivity. | 10.19 grams | Standard Deviation 11.37 |
| NUPRO Sensodyne Prophy Paste w/ Novamin(r) w/ Fluoride. | Extended Sensitivity Relief. Tactile Sensitivity. | 11.07 grams | Standard Deviation 11.9 |
| NUPRO(r) Classic Prophy Paste | Extended Sensitivity Relief. Tactile Sensitivity. | 1.15 grams | Standard Deviation 5.88 |