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This study will compare the safety and effectiveness of two water-based potassium oxalate desensitizers on existing dentinal hypersensitivity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| potassium oxalate gel | Experimental | Professional application |
|
| Potassium oxalate liquid | Active Comparator | Professional application |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Potassium oxalate | Device | Professional application |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline for 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. | 36 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Dentin Sensitivity | 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. | 36 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Athena Papas, DMD, PhD | Tufts University School of Dental Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tufts University School of Dental Medicine | Boston | Massachusetts | 02111 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Potassium Oxalate Gel | Professional application Potassium oxalate: Professional application |
| FG001 | Potassium Oxalate Liquid | Professional application Potassium oxalate: Professional application |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Potassium Oxalate Gel | Professional application Potassium oxalate: Professional application |
| BG001 | Potassium Oxalate Liquid | Professional application Potassium oxalate: Professional application |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 for 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. | Eighty (80) subjects received study products. Seventy-eight (78) subjects completed the study. Two subjects dropped from the study after the Day 6 visit. | Posted | Mean | Standard Error | units on a scale | 36 days |
|
36 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 | Potassium Oxalate Gel | Professional application Potassium oxalate: Professional application |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stomatitis | Gastrointestinal disorders | [not specified] | Non-systematic Assessment |
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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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| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
Professional application Potassium oxalate: Professional application |
| OG001 | Potassium Oxalate Liquid | Professional application Potassium oxalate: Professional application |
|
|
| Secondary | Change From Baseline in Dentin Sensitivity | 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. | Eighty (80) subjects received product. Seventy-eight (78) subjects completed the study. Two subjects dropped from the study after the Day 6 visit. | Posted | Mean | Standard Error | untis on a scale | 36 days |
|
|
|
| 0 |
| 45 |
| 0 |
| 45 |
| 2 |
| 45 |
| EG001 | Potassium Oxalate Liquid | Professional application Potassium oxalate: Professional application | 0 | 35 | 0 | 35 | 1 | 35 |
| Tongue coated | Gastrointestinal disorders | [not specified] | Non-systematic Assessment |
|
| Gingival abscess | Infections and infestations | [not specified] | Non-systematic Assessment |
|
Written consent from Sponsor