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The objective of this study is to compare professional treatments for dentinal hypersensitivity immediately following a single, professionally-applied treatment and again approximately 2 months following treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Super Seal® Desensitizer | Experimental | Professionally Applied |
|
| Acclean® Fluoride Varnish | Sham Comparator | Professionally Applied |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Super Seal® Desensitizer | Device | Single dose professional application. |
| |
| 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. A negative change from Baseline score represents a decrease in sensitivity from baseline.The mean change from Baseline was calculated for this measure. | Within 5 minutes after treatment was applied |
| 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. A negative change from Baseline score represents a decrease in sensitivity from baseline. | Within 5 minutes after treatment was applied |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Title | Description |
|---|---|---|
| FG000 | Super Seal® Desensitizer | Professionally Applied Super Seal® Desensitizer: Single dose professional application. |
| FG001 | Acclean® Fluoride Varnish | Professionally Applied Acclean® Fluoride Varnish: Single dose professional application. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Super Seal® Desensitizer | Professionally Applied Super Seal® Desensitizer: Single dose professional application. |
| BG001 | Acclean® Fluoride Varnish | Professionally Applied Acclean® Fluoride Varnish: Single dose professional application. |
| 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/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. A negative change from Baseline score represents a decrease in sensitivity from baseline.The mean change from Baseline was calculated for this measure. | Twenty-two (22) subjects received study product and completed the study. | Posted | Mean | Standard Deviation | Units on a scale | Within 5 minutes after treatment was applied |
|
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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 | Super Seal® Desensitizer | Professionally Applied Super Seal® Desensitizer: Single dose professional application. |
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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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| Acclean® Fluoride Varnish |
| Device |
Single dose professional application. |
|
| 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 |
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| Region of Enrollment | Number | participants |
|
Professionally Applied Super Seal® Desensitizer: Single dose professional application. |
| OG001 | Acclean® Fluoride Varnish | Professionally Applied Acclean® Fluoride Varnish: Single dose professional application. |
|
|
| Primary | 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. A negative change from Baseline score represents a decrease in sensitivity from baseline. | Twenty-two (22) subjects received product and completed the study. | Posted | Mean | Standard Deviation | Units on a scale | Within 5 minutes after treatment was applied |
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | Acclean® Fluoride Varnish | Professionally Applied Acclean® Fluoride Varnish: Single dose professional application. | 0 | 11 | 0 | 11 | 0 | 11 |
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