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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| oxalate liquid & gel plus SnF2 paste | Other | Potassium oxalate liquid, professionally applied Potassium oxalate gel, self applied Stannous fluoride paste, self applied |
|
| oxalate liquid & gel plus NaF paste | Other | Potassium oxalate liquid, professionally applied Potassium oxalate gel, self applied Sodium fluoride paste, self applied |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Potassium oxalate | Device | Professionally applied (liquid) and self applied (gel) |
|
| 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/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. | 60 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. | 60 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chad J Anderson, MS, DMD | Chad J Anderson DMD Inc | Principal Investigator |
| 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 & 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 |
| 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 | 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. | 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. | Posted | Mean | Standard Deviation | Units on a scale | 60 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 & 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperesthesia | Gastrointestinal disorders | COSTART | Non-systematic Assessment | Burning and painful mouth |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Manager | The Procter & Gamble Company | 513-622-2489 | peters.j.2@pg.com |
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| ID | Term |
|---|---|
| D003807 | Dentin Sensitivity |
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D007154 | Immune System Diseases |
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| Sodium fluoride paste | Drug | Toothpaste used by subject |
|
|
| Stannous fluoride paste | Drug | Toothpaste used by subject |
|
|
| 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG000 |
| 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 |
| OG001 | 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 |
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | Units on a scale | 60 days |
|
|
|
| 1 |
| 14 |
| 0 |
| 14 |
| 1 |
| 14 |
| EG001 | 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 | 0 | 15 | 0 | 15 | 0 | 15 |
|
| PAIN | Gastrointestinal disorders | COSTART | Non-systematic Assessment | Painful mouth, mild and possibly related |
|
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