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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NUPRO(r) Classic Prophy Paste | Active Comparator |
| |
| NUPRO Sensodyne Prophy Paste w/ Novamin(r) w/ fluoride. | Experimental |
| |
| NUPRO Sensodyne Prophy Paste w/ Novamin | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NUPRO Classic Prophy Paste | Device | Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Immediately after treatment. |
| Adverse Events. | Assessment of adverse events that may occur as a result of treatment (typically includes any kind of allergic reation to paste). | Immediately after treatment to 28 days (+/- 2 days) post treatment. |
| 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. | Immediately after treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffery L. Milleman, DDS, MPA | Salus Research | Principal Investigator |
| Kimberly R. Milleman, ASDH, MS | Salus Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Salus Research | Fort Wayne | Indiana | 46825 | United States |
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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | NUPRO Sensodyne Prophy Paste w/ Novamin | NUPRO Sensodyne Prophy Paste with Novamin without fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth. |
| FG001 | 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. |
| FG002 | NUPRO(r) Classic Prophy Paste | NUPRO Classic Prophy Paste : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Intent to treat (ITT).
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| ID | Title | Description |
|---|---|---|
| BG000 | NUPRO Sensodyne Prophy Paste w/ Novamin | NUPRO Sensodyne Prophy Paste with Novamin without fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth. |
| BG001 | NUPRO Sensodyne Prophy Paste w/ Novamin(r) w/ Fluoride. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Intention to treat (ITT). | Posted | Mean | Standard Deviation | grams | Immediately after treatment. |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | NUPRO Sensodyne Prophy Paste w/ Novamin | NUPRO Sensodyne Prophy Paste with Novamin without fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeffery L. Milleman, DDS, MPA | Salus Research, Inc. | (260) 755-1099 |
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| ID | Term |
|---|---|
| D003807 | Dentin Sensitivity |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| NUPRO Sensodyne Prophy Paste with Novamin with fluoride. | Device | Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth. |
|
| NUPRO Sensodyne Prophy Paste with Novamin without fluoride. | Device | Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth. |
|
| 28 days (+/- 2 days) post treatment. |
| 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. | 28 days (+/- 2 days) post treatment. |
NUPRO Sensodyne Prophy Paste with Novamin with fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth. |
| BG002 | NUPRO(r) Classic Prophy Paste | NUPRO Classic Prophy Paste : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
NUPRO Sensodyne Prophy Paste with Novamin with fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth. |
| OG002 | NUPRO(r) Classic Prophy Paste | NUPRO Classic Prophy Paste : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth. |
|
|
| Primary | Adverse Events. | Assessment of adverse events that may occur as a result of treatment (typically includes any kind of allergic reation to paste). | Intent to treat (ITT). | Posted | Number | Number of adverse events. | Immediately after treatment to 28 days (+/- 2 days) post treatment. |
|
|
|
| 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. | Intent to treat (ITT). | Posted | Mean | Standard Deviation | grams | 28 days (+/- 2 days) post treatment. |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Immediately after treatment. |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | 28 days (+/- 2 days) post treatment. |
|
|
|
| 0 |
| 52 |
| 0 |
| 52 |
| EG001 | 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. | 0 | 49 | 0 | 49 |
| EG002 | NUPRO(r) Classic Prophy Paste | NUPRO Classic Prophy Paste : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth. | 0 | 50 | 0 | 50 |
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