The purpose of this study is to evaluate the effectiveness of the oral rinse comparing to MucoPEG™ and Biotene®. This is a randomized open-label crossover study with 42 patients receiving treatment. Patients will be randomly assigned to receive either the MucoPEG™ or the Biotene® Dry Mouth Gentle Oral Rinse in the first period. Patients will use the assigned oral rinse two times a day for two weeks. Patients will switch to the other treatment after a wash-out period of one week.
The purpose of this study is to compare MucoPEG™ and it temporal change to those of the Biotene® Dry Mouth Gentle Oral Rinse in patients with Xerostomia. The study will gather data on patient reported outcomes on the safety and performance of the product, mouth-feel qualities and any changes in dry mouth.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
42
ColoradoENT
Colorado Springs, Colorado, United States
Tufts University School of Dental Medicine
Boston, Massachusetts, United States
Change in VAS for Mouth Dryness
To demonstrate the effectiveness of MucoPEG is better than that of Biotene Dry Mouth Gentle Oral Rinse in relieving xerostomia. Effectiveness will be addressed using the Visual Analogue Scale (VAS). (VAS), where 0 is "Not Dry at All" and 10 is "Very Dry" VAS (before), which is measured before using any of the products on the first day of each treatment period, at Visit 2 or Visit 5. VAS (end), which is measured after the last dose of a product on the final day of each treatment period, at Visit 4 or Visit 7. Change in the rating of mouth dryness is the difference between the two time points, that is, VAS (end) - VAS (before).
Time frame: baseline and 2 weeks, value at 2weeks minus value at baseline
Dry Mouth Relief Questionnaires (DMRQ)
The effect of MucoPEG™ in relieving xerostomia, relative to that of Biotène was assessed using the Dry Mouth Relief Questionnaires (DMRQ). This questionnaire was given to the patients to answer the following question: "Does the product relieve the discomfort of dry mouth?" To answer the question, only one of the answer options is selected: 1. None/ (No Relief), 2. Not Enough, 3. Some/ Good, 4. Very Good, 5. Significant/ Excellent A favorable responses on the Dry Mouth Relief Questionnaire (DMRQ) include "4 - very good" or "5 - significant/excellent." The numbers are the number of patients who responded favorably at their last visit.
Time frame: 2 weeks(at last visit)
Change in VAS for Tongue Dryness
To demonstrate the effectiveness of MucoPEG is better than that of Biotene Dry Mouth Gentle Oral Rinse in relieving xerostomia. Effectiveness will be addressed using the Visual Analogue Scale (VAS). (VAS), where 0 is "Not Dry at All" and 10 is "Very Dry" VAS (before), which is measured before using any of the products on the first day of each treatment period, at Visit 2 or Visit 5. VAS (end), which is measured after the last dose of a product on the final day of each treatment period, at Visit 4 or Visit 7. Change in the rating of mouth dryness is the difference between the two time points, that is, VAS (end) - VAS (before).
Time frame: baseline and 2 weeks, value at 2weeks minus value at baseline
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Number of Participants With Treatment-related Adverse Events as Evaluated by the Principal Investigator
To evaluate the clinical safety of MucoPEG. Patient reported outcomes will be evaluated by the Principal Investigator.
Time frame: 2 weeks
Dry Mouth Inventory (DMI) Questionnaire.
To demonstrate the effectiveness using the Dry Mouth Inventory (DMI). There are 8 Dry Mouth Inventory (DMI) questionaires as follows. 1. My mouth feels dry, 2. I have difficulty eating dry foods, 3. I get up at night to drink, 4. My mouth feels dry when eating a meal, 5. I sip liquids to aid in swallowing food, 6. I suck sweets or cough lollies to relieve dry mouth, 7. My lips stick to the teeth, 8. My tongue sticks to the roof of my mouth. Using a scale from "Disagree (0)" to "Strongly agree (3)". The scale has a minimum value of "0" and a maximum value of "24". The larger the scale, the more severe the dry mouth.
Time frame: 2 weeks