Determination of the Safety and Effectiveness of an Oral Rinse in the Reduction of Medication Associated Metallic Taste
|ClinicalTrials.gov Identifier: NCT02992314|
Recruitment Status : Completed
First Posted : December 14, 2016
Last Update Posted : January 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|Medication Associated Metallic Taste , Dysgeusia||Device: Metaqil™ Oral Rinse Device: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||52 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Primary Purpose:||Supportive Care|
|Official Title:||Determination of the Safety and Effectiveness of an Oral Rinse in the Reduction of Medication Associated Metallic Taste|
|Actual Study Start Date :||May 22, 2017|
|Actual Primary Completion Date :||September 18, 2018|
|Actual Study Completion Date :||December 31, 2018|
Experimental: Metaqil™ Oral Rinse
In this arm the test article, Metaqil ™ 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.
Device: Metaqil™ Oral Rinse
Metaqil™ is a proprietary formulation of GRAS ingradients
Placebo Comparator: Placebo Oral Rinse
This arm will use a placebo with out the active ingredients same way the experimental arm do.
Placebo formulation with out the active ingredients
- Relief of medication associated metallic taste [ Time Frame: 4 weeks ]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..
- Safety evaluation of the test Oral Rinse [ Time Frame: 4 Weeks ]Evaluate extra- and intra- oral areas for any mucosal irritation or pathology.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02992314
|United States, New York|
|Department of Periodontics and Endodontics,School of Dental Medicine, University at Buffalo, SUNY|
|Buffalo, New York, United States, 14214|