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Patients taking chemotherapeutic agents often do not comply well with their dosing regiment since many of these medications cause a metallic taste in the mouth. The primary intent is to determine the effectiveness of the oral rinse in reducing the metallic taste in the mouth associated with various chemotherapeutic agents. This clinical study a randomized, double-blind, single-treatment, parallel design with a placebo as the control. The duration of the trial will be 1 month.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metaqilâ„¢ Oral Rinse | Experimental | In this arm the test article, Metaqil â„¢ oral rinse, a proprietary formulation of agents including Monk fruit extract, which can minimize the metallic taste in the mouth caused by the patient's medications. Subjects rinse twice a day with 10 mL of the oral rinse for 30 seconds for 30 days. They will note, in the daily oral hygiene diary, the date and time of brushing and rinsing. |
|
| Placebo Oral Rinse | Placebo Comparator | This arm will use a placebo with out the active ingredients same way the experimental arm do. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metaqilâ„¢ Oral Rinse | Device | Metaqilâ„¢ is a proprietary formulation of GRAS ingradients |
|
| Measure | Description | Time Frame |
|---|---|---|
| Relief of medication associated metallic taste | Have patient complete a VAS ( visual analogue scale) scoring of the degree of metallic taste in the mouth as well as a VAS scoring of the amount of relief of the metallic taste.. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Safety evaluation of the test Oral Rinse | Evaluate extra- and intra- oral areas for any mucosal irritation or pathology. | 4 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Periodontics and Endodontics,School of Dental Medicine, University at Buffalo, SUNY | Buffalo | New York | 14214 | United States |
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| ID | Term |
|---|---|
| D004408 | Dysgeusia |
| ID | Term |
|---|---|
| D013651 | Taste Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| Placebo | Device | Placebo formulation with out the active ingredients |
|
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |