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Xerostomia causes a difficulty in eating, have irritated oral tissues, and a poor quality of life. The new oral rinse was designed to reduce the symptoms and improve the patient's quality of life. The objectives of the clinical study is to evaluate the effectiveness of the oral rinse comparing to the placebo product and the control product in the market.
This is a randomized double-blind placebo controlled crossover study with 39 patients receiving treatment. Patients will be randomly allocated to three treatment groups. Patients will use the assigned oral rinse four times a day for two weeks. Dry mouth symptoms and other endpoints will be assessed subjectively and objectively at baseline and Day 14. Patients will be assigned to another treatment after one week wash-out period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HYDRAL Oral Rinse | Experimental | Subjects use the oral rinse four times daily adding to a regular oral hygiene routine with a fluoride toothpaste and a soft tooth brush. |
|
| BIOTENE® Oral Rinse | Active Comparator | Subjects use the oral rinse four times daily adding to a regular oral hygiene routine with a fluoride toothpaste and a soft tooth brush. |
|
| Placebo Oral Rinse | Placebo Comparator | Subjects use the oral rinse four times daily adding to a regular oral hygiene routine with a fluoride toothpaste and a soft tooth brush. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HYDRAL Oral Rinse | Device | Application 4 times a day for two weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Dry Mouth Symptom by Visual Analog Scale at 14 Days From Baseline | 100 mm visual analog scale for subjective scoring the level of dry mouth (0 mm: not dry at all, 100 mm: very dry). Change in mm was calculated by subtracting the measurement at 14 days from the measurement at baseline. Higher values of the changes from baseline represent a better outcome. | Baseline, 14 days |
| Change in Dry Mouth Symptoms by Xerostomia Questionnaire at 14 Days From Baseline | Questionnaire to assess xerostomia symptoms. Subjects were asked the degree (grade 0: no problems to grade 3: the worst possible problem) of hoarse voice, oral dryness, oral pain, swallowing, and taste loss from which they were suffering in the xerostomia questionnaire. The symptoms scores were summed to calculate a total score per each subject (minimum total score: 0, maximum total score: 15). The change was calculated by subtracting the total score at 14 days from the total score at baseline. Higher values of the changes represent a better outcome (minimum change: -15, maximum change: 15). | Baseline, 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Oral Functions by Revised Oral Assessment Guide at 14 Days From Baseline | Assessment of oral functions by a dental professional. Eight categories were included in the assessment guide: voice, lips, mucous membranes, tongue, gums, teeth, saliva, and swallowing. Each category was described and rated from healthy (score 1) to severe (score 3). Scores for the categories were summed to calculate a total score per each subject (minimum total score: 8, maximum total score: 24). The change was calculated by subtracting the total score at 14 days from the total score at baseline. Higher values of the changes represent a better outcome (minimum change: -16, maximum change: 16). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University at Buffalo, The Center for Dental Studies | Buffalo | New York | 14214 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | HYDRAL Oral Rinse - Placebo Oral Rinse - Biotene Oral Rinse | Subjects use following oral rinses four times daily adding to a regular oral hygiene routine with a fluoride toothpaste and a soft tooth brush. One-week washout period separates two different interventions of two weeks. First intervention: HYDRAL Oral Rinse Second intervention: Placebo Oral Rinse Third intervention: BIOTENE® Oral Rinse |
| FG001 | Placebo Oral Rinse - Biotene Oral Rinse - HYDRAL Oral Rinse | Subjects use following oral rinses four times daily adding to a regular oral hygiene routine with a fluoride toothpaste and a soft tooth brush. One-week washout period separates two different interventions of 2 weeks. First intervention: Placebo Oral Rinse Second intervention: BIOTENE® Oral Rinse Third intervention: HYDRAL Oral Rinse |
| FG002 | BIOTENE Oral Rinse - HYDRAL Oral Rinse - Placebo Oral Rinse | Subjects use following oral rinses four times daily adding to a regular oral hygiene routine with a fluoride toothpaste and a soft tooth brush. One-week washout period separates two different interventions of two weeks. First intervention: BIOTENE® Oral Rinse Second intervention: HYDRAL Oral Rinse Third intervention: Placebo Oral Rinse |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Participants | Subject disposition for all arms |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 in Dry Mouth Symptom by Visual Analog Scale at 14 Days From Baseline | 100 mm visual analog scale for subjective scoring the level of dry mouth (0 mm: not dry at all, 100 mm: very dry). Change in mm was calculated by subtracting the measurement at 14 days from the measurement at baseline. Higher values of the changes from baseline represent a better outcome. | Posted | Mean | Standard Deviation | mm | Baseline, 14 days |
|
14 days
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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 | HYDRAL Oral Rinse | Subjects use the oral rinse four times daily adding to a regular oral hygiene routine with a fluoride toothpaste and a soft tooth brush for two weeks. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Oral mucosal irritation | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Akane Takemura | Sunstar Americas, Inc. | 18477944276 | akane.takemura@us.sunstar.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 13, 2020 | Dec 17, 2021 | Prot_SAP_000.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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| BIOTENE® Oral Rinse | Device | Application 4 times a day for two weeks |
|
| Placebo Oral Rinse | Device | Application 4 times a day for two weeks |
|
| Baseline, 14 days |
| Change in Unstimulated Saliva Flow Rate at 14 Days From Baseline | Unstimulated whole saliva was collected over a 5-minute time period and the volume was measured. Change in mL per minute was calculated by subtracting the measurement at baseline from the measurement at 14 days. | Baseline, 14 days |
| years |
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| Sex: Female, Male | 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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| OG002 | BIOTENE® Oral Rinse | Subjects use the oral rinse four times daily adding to a regular oral hygiene routine with a fluoride toothpaste and a soft tooth brush for two weeks. |
|
|
| Primary | Change in Dry Mouth Symptoms by Xerostomia Questionnaire at 14 Days From Baseline | Questionnaire to assess xerostomia symptoms. Subjects were asked the degree (grade 0: no problems to grade 3: the worst possible problem) of hoarse voice, oral dryness, oral pain, swallowing, and taste loss from which they were suffering in the xerostomia questionnaire. The symptoms scores were summed to calculate a total score per each subject (minimum total score: 0, maximum total score: 15). The change was calculated by subtracting the total score at 14 days from the total score at baseline. Higher values of the changes represent a better outcome (minimum change: -15, maximum change: 15). | Posted | Mean | Standard Deviation | Score on a scale | Baseline, 14 days |
|
|
|
| Secondary | Change in Oral Functions by Revised Oral Assessment Guide at 14 Days From Baseline | Assessment of oral functions by a dental professional. Eight categories were included in the assessment guide: voice, lips, mucous membranes, tongue, gums, teeth, saliva, and swallowing. Each category was described and rated from healthy (score 1) to severe (score 3). Scores for the categories were summed to calculate a total score per each subject (minimum total score: 8, maximum total score: 24). The change was calculated by subtracting the total score at 14 days from the total score at baseline. Higher values of the changes represent a better outcome (minimum change: -16, maximum change: 16). | Posted | Mean | Standard Deviation | Score on a scale | Baseline, 14 days |
|
|
|
| Secondary | Change in Unstimulated Saliva Flow Rate at 14 Days From Baseline | Unstimulated whole saliva was collected over a 5-minute time period and the volume was measured. Change in mL per minute was calculated by subtracting the measurement at baseline from the measurement at 14 days. | Posted | Mean | Standard Deviation | mL/min | Baseline, 14 days |
|
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| 0 |
| 37 |
| 0 |
| 37 |
| 2 |
| 37 |
| EG001 | Placebo Oral Rinse | Subjects use the oral rinse four times daily adding to a regular oral hygiene routine with a fluoride toothpaste and a soft tooth brush for two weeks. | 0 | 37 | 0 | 37 | 2 | 37 |
| EG002 | BIOTENE® Oral Rinse | Subjects use the oral rinse four times daily adding to a regular oral hygiene routine with a fluoride toothpaste and a soft tooth brush for two weeks. | 0 | 37 | 0 | 37 | 6 | 37 |
| Urinary tract infection | Infections and infestations | Non-systematic Assessment |
|
| Sneezing | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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