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This study will determine the effects toothbrush type (power or manual) has on the safety and effectiveness of professional dentinal hypersensitivity treatment with a marketed oxalate-containing solution.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| oxalate liquid, SnF2 paste, manual toothbrush | Other | Potassium oxalate liquid, professionally applied Stannous fluoride paste, self applied Manual toothbrush |
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| oxalate liquid, SnF2 paste, power toothbrush | Other | Potassium oxalate liquid, professionally applied Stannous fluoride paste, self applied Power toothbrush |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Potassium Oxalate | Device | Professionally applied liquid |
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| Measure | Description | Time Frame |
|---|---|---|
| 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/subject responds to stimulus and requests discontinuation or moves form 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. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chad J Anderson DMD Inc | Fresno | California | 93730 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Oxalate Liquid, SnF2 Paste, Manual Toothbrush | Potassium oxalate liquid, professionally applied Stannous fluoride paste, self applied Manual toothbrush Potassium Oxalate: Professionally applied liquid Stannous fluoride paste: SnF2 Paste Manual toothbrush: Marketed manual toothbrush |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Stannous fluoride paste | Drug | SnF2 Paste |
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| Manual toothbrush | Device | Marketed manual toothbrush |
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| Power toothbrush | Device | Marketed power toothbrush |
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| Oxalate Liquid, SnF2 Paste, Power Toothbrush |
Potassium oxalate liquid, professionally applied Stannous fluoride paste, self applied Power toothbrush Potassium Oxalate: Professionally applied liquid Stannous fluoride paste: SnF2 Paste Power toothbrush: Marketed power toothbrush |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Oxalate Liquid, SnF2 Paste, Manual Toothbrush | Potassium oxalate liquid, professionally applied Stannous fluoride paste, self applied Manual toothbrush Potassium Oxalate: Professionally applied liquid Stannous fluoride paste: SnF2 Paste Manual toothbrush: Marketed manual toothbrush |
| BG001 | Oxalate Liquid, SnF2 Paste, Power Toothbrush | Potassium oxalate liquid, professionally applied Stannous fluoride paste, self applied Power toothbrush Potassium Oxalate: Professionally applied liquid Stannous fluoride paste: SnF2 Paste Power toothbrush: Marketed power toothbrush |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | 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/subject responds to stimulus and requests discontinuation or moves form 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. | Posted | Mean | Standard Deviation | Units on a scale | 30 days |
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| 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. | Posted | Mean | Standard Deviation | Units on a scale | 30 days |
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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 | Oxalate Liquid, SnF2 Paste, Manual Toothbrush | Potassium oxalate liquid, professionally applied Stannous fluoride paste, self applied Manual toothbrush Potassium Oxalate: Professionally applied liquid Stannous fluoride paste: SnF2 Paste Manual toothbrush: Marketed manual toothbrush | 0 | 12 | 0 | 12 | 0 | 12 |
| EG001 | Oxalate Liquid, SnF2 Paste, Power Toothbrush | Potassium oxalate liquid, professionally applied Stannous fluoride paste, self applied Power toothbrush Potassium Oxalate: Professionally applied liquid Stannous fluoride paste: SnF2 Paste Power toothbrush: Marketed power toothbrush | 0 | 12 | 0 | 12 | 0 | 12 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Manager | The Procter & Gamble Company | 513-622-2489 | peters.j.2@pg.com |
| ID | Term |
|---|---|
| D003807 | Dentin Sensitivity |
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D007154 | Immune System Diseases |
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| >=65 years |
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| Male |
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| Black |
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| Asian Oriental |
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| Multi-Racial |
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| Hispanic |
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