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Hypersensitivity
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | sensitive toothpaste |
|
| B | Active Comparator | Triclosan control toothpaste |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triclosan, Silicon dioxide, fluoride | Drug | Brush twice daily |
| |
| Triclosan, fluoride |
| Measure | Description | Time Frame |
|---|---|---|
| Hypersensitivity Tactile(Yeaple Probe) | Measured with an electronic force sensing probe (Yeaple Probe): 10, 20, 30, 40, up to 50 grams of force are applied to hypersensitive tooth until pain elicited. Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. For Tactile Hypersensitivity: The higher the score (the more grams of force needed to elicit a response of pain), the lower the hypersensitivity. Hypersensitivity scores on a per study subject basis are recorded as mean scores of two hypersensitive teeth | 4 weeks |
| Hypersensitivity Tactile (Yeaple Probe) | Measured with an electronic force sensing probe (Yeaple Probe): 10, 20, 30, 40, up to 50 grams of force are applied to hypersensitive tooth until pain elicited. Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. For Tactile Hypersensitivity: The higher the score (the more grams of force needed to elicit a response of pain), the lower the hypersensitivity. Hypersensitivity scores on a per study subject basis are recorded as mean scores of two hypersensitive teeth | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Air Blast Hypersensitivity (4 Week) | Examiner rates the response to stimulation of hypersensitive teeth using a jet of air (constant stimulus on the basis of duration, pressure, temperature, distance from target). Response is rated based on the Schiff Cold Air Sensitivity Scale.This analog scale scores for the tooth is 0,1,2 or 3:"0"No subject response to stimulus"1"responds but will continue"2"responds and moves or requests discontinuation"3"Painful response to stimulus, discontinuation requested. The lower the score, the lower the hypersensitivity.Scores per study subject are recorded as mean scores of two hypersensitive teeth. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Augusto Elias, DDS | Univ of Puerto Rico | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Concordia Clinical Research | Cedar Knolls | New Jersey | 08225 | United States |
subjects were screened for medical and oral health criteria and then entered a 1 week washout before study treatment period.
subjects were recruited by the PI at the clinical site
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| ID | Title | Description |
|---|---|---|
| FG000 | A-Experimental Toothpatse | fluoride/triclosan/silica dioxide toothpaste (Sensitive teeth formula) |
| FG001 | B -Control Toothpaste | Fluoride/Triclosan control toothpaste |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | A-Experimental Toothpatse | fluoride/triclosan/silica dioxide toothpaste (Sensitive teeth formula) |
| BG001 | B -Control Toothpaste | Fluoride/Triclosan control toothpaste |
| 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 | Hypersensitivity Tactile(Yeaple Probe) | Measured with an electronic force sensing probe (Yeaple Probe): 10, 20, 30, 40, up to 50 grams of force are applied to hypersensitive tooth until pain elicited. Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. For Tactile Hypersensitivity: The higher the score (the more grams of force needed to elicit a response of pain), the lower the hypersensitivity. Hypersensitivity scores on a per study subject basis are recorded as mean scores of two hypersensitive teeth | Posted | Mean | Standard Deviation | units on a scale | 4 weeks |
|
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 | A-Experimental Toothpatse | fluoride/triclosan/silica dioxide toothpaste (Sensitive teeth formula) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Burning sensation of mucosa | General disorders | Non-systematic Assessment | subject reported burning sensation on tongue, cheeks and lips. subject discontinued during the 4 weeks visit. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| William De Vizio | Colgate Palmolive Co. | 732-878-7901 | William_Devizio@colpal.com |
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| ID | Term |
|---|---|
| D003807 | Dentin Sensitivity |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D014260 | Triclosan |
| D012822 | Silicon Dioxide |
| D005459 | Fluorides |
| ID | Term |
|---|---|
| D010647 | Phenyl Ethers |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
| D010636 | Phenols |
| D001555 |
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| Drug |
Brush twice daily |
|
| 4 weeks |
| Air Blast Hypersensitivity (8 Week) | Examiner rates the response to stimulation of hypersensitive teeth using a jet of air (constant stimulus on the basis of duration, pressure, temperature, distance from target). Response is rated based on the Schiff Cold Air Sensitivity Scale.This analog scale scores for the tooth is 0,1,2 or 3:"0"No subject response to stimulus"1"responds but will continue"2"responds and moves or requests discontinuation"3"Painful response to stimulus, discontinuation requested. The lower the score, the lower the hypersensitivity.Scores per study subject are recorded as mean scores of two hypersensitive teeth. | 8 weeks |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Fluoride/Triclosan control toothpaste |
|
|
|
| Primary | Hypersensitivity Tactile (Yeaple Probe) | Measured with an electronic force sensing probe (Yeaple Probe): 10, 20, 30, 40, up to 50 grams of force are applied to hypersensitive tooth until pain elicited. Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. For Tactile Hypersensitivity: The higher the score (the more grams of force needed to elicit a response of pain), the lower the hypersensitivity. Hypersensitivity scores on a per study subject basis are recorded as mean scores of two hypersensitive teeth | Posted | Mean | Standard Deviation | Units on a scale | 8 weeks |
|
|
|
|
| Secondary | Air Blast Hypersensitivity (4 Week) | Examiner rates the response to stimulation of hypersensitive teeth using a jet of air (constant stimulus on the basis of duration, pressure, temperature, distance from target). Response is rated based on the Schiff Cold Air Sensitivity Scale.This analog scale scores for the tooth is 0,1,2 or 3:"0"No subject response to stimulus"1"responds but will continue"2"responds and moves or requests discontinuation"3"Painful response to stimulus, discontinuation requested. The lower the score, the lower the hypersensitivity.Scores per study subject are recorded as mean scores of two hypersensitive teeth. | Posted | Mean | Standard Deviation | units on a scale | 4 weeks |
|
|
|
|
| Secondary | Air Blast Hypersensitivity (8 Week) | Examiner rates the response to stimulation of hypersensitive teeth using a jet of air (constant stimulus on the basis of duration, pressure, temperature, distance from target). Response is rated based on the Schiff Cold Air Sensitivity Scale.This analog scale scores for the tooth is 0,1,2 or 3:"0"No subject response to stimulus"1"responds but will continue"2"responds and moves or requests discontinuation"3"Painful response to stimulus, discontinuation requested. The lower the score, the lower the hypersensitivity.Scores per study subject are recorded as mean scores of two hypersensitive teeth. | Posted | Mean | Standard Deviation | units on a scale | 8 weeks |
|
|
|
|
| 0 |
| 314 |
| 3 |
| 314 |
| EG001 | B -Control Toothpaste | Fluoride/Triclosan control toothpaste | 0 | 312 | 4 | 312 |
|
| Redness in Perioral area (possible allergic reaction) | General disorders | Non-systematic Assessment | subject observed redness in perioral area. visited dermatologist who diagnosed a possible allergic reaction and recommended to discontinue study toothpaste. |
|
| Physical Accidents w/ injuries | General disorders | Non-systematic Assessment | Several subjects reported accident. 1 had a workplace accident and was put on bedrest. 1 fell and broke wrist while walking.1 fell in backyard and broke a bone in left foot. adn 1 subject reported 2 events(a foot sprain and a broken left foot bone. |
|
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| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D008903 | Minerals |
| D007287 | Inorganic Chemicals |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
| D017655 | Silicon Compounds |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D006858 | Hydrofluoric Acid |
| D017611 | Fluorine Compounds |