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This study will assess the oral tolerability and immediate post-treatment safety of topical application for two marketed oxalate products as initial care in dental patients to treat or prevent tooth sensitivity pain that may be attributed to dentinal hypersensitivity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| potassium oxalate gel | Other | potassium oxalate gel self applied |
|
| oxalate liquid, SnF2 paste | Other | Potassium oxalate liquid professionally applied, Stannous fluoride paste self applied |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Potassium Oxalate Gel | Device | Self applied |
| |
| Potassium Oxalate Liquid |
| Measure | Description | Time Frame |
|---|---|---|
| How Satisfied Were Participants With Treatment? | Questionnaire indicating the frequencies of using various oral hygiene products by subjects at 5 different dental practices. | up to 8 weeks |
| Ease of Treatment at Home | Questionnaire indicating the frequencies of using various oral hygiene products by subjects at 5 different dental practices. | Up to 8 weeks |
| Did Participants Notice a Difference in the Areas Noted? | Questionnaire indicating the frequencies of using various oral hygiene products by subjects at 5 different dental practices. | Up to 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| 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 | potassium oxalate gel self applied Potassium Oxalate Gel: Self applied |
| FG001 | Oxalate Liquid, SnF2 Paste | Potassium oxalate liquid professionally applied, Stannous fluoride paste self applied Potassium Oxalate Liquid: Professionally Applied Stannous fluoride paste: SnF2 Paste |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Device |
Professionally Applied |
|
| Stannous fluoride paste | Drug | SnF2 Paste |
|
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Potassium Oxalate Gel | potassium oxalate gel self applied Potassium Oxalate Gel: Self applied |
| BG001 | Oxalate Liquid, SnF2 Paste | Potassium oxalate liquid professionally applied, Stannous fluoride paste self applied Potassium Oxalate Liquid: Professionally Applied Stannous fluoride paste: SnF2 Paste |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | 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 | How Satisfied Were Participants With Treatment? | Questionnaire indicating the frequencies of using various oral hygiene products by subjects at 5 different dental practices. | Posted | Count of Participants | Participants | up to 8 weeks |
|
|
| ||||||||||||||||||||||||||||||||
| Primary | Ease of Treatment at Home | Questionnaire indicating the frequencies of using various oral hygiene products by subjects at 5 different dental practices. | Posted | Count of Participants | Participants | Up to 8 weeks |
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| Primary | Did Participants Notice a Difference in the Areas Noted? | Questionnaire indicating the frequencies of using various oral hygiene products by subjects at 5 different dental practices. | Posted | Count of Participants | Participants | Up to 8 weeks |
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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 | potassium oxalate gel self applied Potassium Oxalate Gel: Self applied | 0 | 57 | 0 | 57 | ||
| EG001 | Oxalate Liquid, SnF2 Paste | Potassium oxalate liquid professionally applied, Stannous fluoride paste self applied Potassium Oxalate Liquid: Professionally Applied Stannous fluoride paste: SnF2 Paste | 0 | 47 | 0 | 47 |
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PI should disclose plans to sponsor prior to public release.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Manager | Procter and Gamble | 513-622-2489 | peters.j.2@pg.com |
| Male |
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| Neutral |
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| Somewhat Satisfied |
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| Very Satisfied |
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