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To determine the duration of effect of a single dose of Biotène Moisturizing Mouth Spray in subjects who complain of a clinically dry mouth. The effect of the product will be compared to a control spray (water).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biotene | Experimental | People who present with dry mouth and will receive a single dose of Biotene. |
|
| Placebo | Placebo Comparator | People who present with dry mouth and will receive a single dose of an alternative agent. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biotene | Device | Biotène Dry Mouth Moisturizing Spray contains water, polyglycitol, propylene glycol, sunflower oil, xylitol, milk protein extract, potassium sorbate, acesulfame K, potassium thiocyanate, lysozyme, lactoferrin, lactoperoxidase. 3 sprays, approximately 15 mL. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Duration of Action of Intervention | Participant will receive a dose of Biotene or placebo (water) and will be asked if their mouth is dry up to 2 hrs. The time at which their mouth becomes dry again will be the duration of action. | baseline up to 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Tolerability of Product | Subjects were asked to agree or disagree with the following statement where 1= strongly agree and 5- strongly disagree: The taste of the product was tolerable. | 2 hours |
| Mean Acceptability of Product |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester Eastman Dental Center | Rochester | New York | 14620 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33602603 | Derived | Lung CB, Watson GE, Verma S, Feng C, Saunders RH. Duration of effect of Biotene spray in patients with symptomatic dry mouth: A pilot study. Oral Surg Oral Med Oral Pathol Oral Radiol. 2021 Apr;131(4):415-421. doi: 10.1016/j.oooo.2020.12.002. Epub 2021 Jan 16. |
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37 subjects were enrolled. 8 subjects failed screening. 16 were randomized to either the Biotene then placebo arm and 13 were randomized to the water then Biotene arm.
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| ID | Title | Description |
|---|---|---|
| FG000 | Biotene Then Placebo | People who present with dry mouth and will receive a single dose of Biotene. Biotene: Biotène Dry Mouth Moisturizing Spray contains water, polyglycitol, propylene glycol, sunflower oil, xylitol, milk protein extract, potassium sorbate, acesulfame K, potassium thiocyanate, lysozyme, lactoferrin, lactoperoxidase. 3 sprays, approximately 15 mL. |
| FG001 | Placebo Then Biotene | People who present with dry mouth and will receive a single dose of an alternative agent. Placebo: IND/IDE exempt device primarily water |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
| |||||||||||||
| Washout |
| |||||||||||||
| Second Intervention |
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| ID | Title | Description |
|---|---|---|
| BG000 | Biotene Then Placebo | People who present with dry mouth and will receive a single dose of Biotene. Biotene: Biotène Dry Mouth Moisturizing Spray contains water, polyglycitol, propylene glycol, sunflower oil, xylitol, milk protein extract, potassium sorbate, acesulfame K, potassium thiocyanate, lysozyme, lactoferrin, lactoperoxidase. 3 sprays, approximately 15 mL. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | One participant did not have data collected for age in the Biotene then Placebo arm. |
| 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 | Mean Duration of Action of Intervention | Participant will receive a dose of Biotene or placebo (water) and will be asked if their mouth is dry up to 2 hrs. The time at which their mouth becomes dry again will be the duration of action. | Posted | Mean | Standard Deviation | minutes | baseline up to 2 hours |
|
2 hours
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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 | Biotene | People who present with dry mouth and will receive a single dose of Biotene. Biotene: Biotène Dry Mouth Moisturizing Spray contains water, polyglycitol, propylene glycol, sunflower oil, xylitol, milk protein extract, potassium sorbate, acesulfame K, potassium thiocyanate, lysozyme, lactoferrin, lactoperoxidase. 3 sprays, approximately 15 mL. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ralph Saunders | University of Rochester | 585-275-1141 | ralph_saunders@urmc.rochester.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jul 5, 2019 | Nov 16, 2020 | ICF_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 22, 2020 | Nov 16, 2020 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D014987 | Xerostomia |
| ID | Term |
|---|---|
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| Placebo | Device | IND/IDE exempt device primarily water |
|
Subjects were asked to agree or disagree with the following statement where 1= strongly agree and 5- strongly disagree: The thickness of the product was acceptable.
| 2 hours |
| Mean Continued Use of Project | Subjects were asked to agree or disagree with the following statement where 1= strongly agree and 5- strongly disagree: I would like to continue using this product. | 2 hours |
| Mean Purchase Product Rating | Subjects were asked to agree or disagree with the following statement where 1= strongly agree and 5- strongly disagree: I would purchase this product to use on a regular basis. | 2 hours |
| Mean Ease of Use of Product | Subjects were asked to agree or disagree with the following statement where 1= strongly agree and 5- strongly disagree: This product is easy to use. | 2 hours |
| Mean Preference for Another Product | Subjects were asked to agree or disagree with the following statement where 1= strongly agree and 5- strongly disagree: I would prefer using another product. | 2 hours |
| NOT COMPLETED |
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| NOT COMPLETED |
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| BG001 |
| Placebo Then Biotene |
People who present with dry mouth and will receive a single dose of an alternative agent. Placebo: IND/IDE exempt device primarily water |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Mean Tolerability of Product | Subjects were asked to agree or disagree with the following statement where 1= strongly agree and 5- strongly disagree: The taste of the product was tolerable. | Data from 1 subject was excluded due to inability to comprehend the instructions for rating xerostomia-related oral discomfort. | Posted | Mean | Standard Deviation | score on a scale | 2 hours |
|
|
|
| Secondary | Mean Acceptability of Product | Subjects were asked to agree or disagree with the following statement where 1= strongly agree and 5- strongly disagree: The thickness of the product was acceptable. | Data from 1 subject was excluded due to inability to comprehend the instructions for rating xerostomia-related oral discomfort. | Posted | Mean | Standard Deviation | score on a scale | 2 hours |
|
|
|
| Secondary | Mean Continued Use of Project | Subjects were asked to agree or disagree with the following statement where 1= strongly agree and 5- strongly disagree: I would like to continue using this product. | Data from 1 subject was excluded due to inability to comprehend the instructions for rating xerostomia-related oral discomfort. | Posted | Mean | Standard Deviation | score on a scale | 2 hours |
|
|
|
| Secondary | Mean Purchase Product Rating | Subjects were asked to agree or disagree with the following statement where 1= strongly agree and 5- strongly disagree: I would purchase this product to use on a regular basis. | Data from 1 subject was excluded due to inability to comprehend the instructions for rating xerostomia-related oral discomfort. | Posted | Mean | Standard Deviation | score on a scale | 2 hours |
|
|
|
| Secondary | Mean Ease of Use of Product | Subjects were asked to agree or disagree with the following statement where 1= strongly agree and 5- strongly disagree: This product is easy to use. | Data from 1 subject was excluded due to inability to comprehend the instructions for rating xerostomia-related oral discomfort. | Posted | Mean | Standard Deviation | score on a scale | 2 hours |
|
|
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| Secondary | Mean Preference for Another Product | Subjects were asked to agree or disagree with the following statement where 1= strongly agree and 5- strongly disagree: I would prefer using another product. | Data from 1 subject was excluded due to inability to comprehend the instructions for rating xerostomia-related oral discomfort. | Posted | Mean | Standard Deviation | score on a scale | 2 hours |
|
|
|
| 0 |
| 29 |
| 0 |
| 29 |
| 0 |
| 29 |
| EG001 | Placebo | People who present with dry mouth and will receive a single dose of an alternative agent. Placebo: IND/IDE exempt device primarily water | 0 | 29 | 0 | 29 | 0 | 29 |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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