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This pilot study will evaluate the use of nominal stimuli to assess dentinal hypersensitivity response relative to a clinically-controlled stimulus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Crest® Sensi-Stop™ Strips | Experimental | Professionally Applied |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Crest® Sensi-Stop™ Strips | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline for Visual Analog Scale - Cold Water | 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. | Day 1 |
| Change From Baseline for Dentin Sensitivity Cold Water as Assessed by the Schiff Index | 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. | Day 1 |
| Change From Baseline for 5 Face Emoticon Scale | Scale to score their comfort/discomfort that ranges from -2 to +2 where a -2 is considered very comfortable and a +2 is considered very uncomfortable. | Day 2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert W Gerlach, DDS, MPH | Procter and Gamble | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oral Health Science Center | Mason | Ohio | 45040 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Crest® Sensi-Stop™ Strips | Professionally Applied Crest® Sensi-Stop™ Strips |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Crest® Sensi-Stop™ Strips | Professionally Applied Crest® Sensi-Stop™ Strips |
| 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 for Visual Analog Scale - Cold Water | 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 product and completed the study. | Posted | Mean | Standard Deviation | Units on a scale | Day 1 |
|
|
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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 | Crest® Sensi-Stop™ Strips | Professionally Applied Crest® Sensi-Stop™ Strips | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gingivitis | Gastrointestinal disorders | COSTART | 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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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Primary | Change From Baseline for Dentin Sensitivity Cold Water as Assessed by the Schiff Index | 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 | Day 1 |
|
|
|
| Primary | Change From Baseline for 5 Face Emoticon Scale | Scale to score their comfort/discomfort that ranges from -2 to +2 where a -2 is considered very comfortable and a +2 is considered very uncomfortable. | Thirty (30) subjects received study product and completed the study. | Posted | Mean | Standard Deviation | Units on a scale | Day 2 |
|
|
|
| 30 |
| 0 |
| 30 |
| 7 |
| 30 |
| Mucous Mem Dis | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
|
| Cheilitis | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
|
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