Clinical Evaluation of MucoPEG™ for Xerostomia

Not Applicable

Completed

Conditions: Dry Mouth
Xerostomia

Interventions: Device: MucoPEG
Device: Biotene

Registration Number: NCT04986501

Lead Sponsor: SunBio, Inc.

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 42

Inclusion Criteria

Must have read, understood and signed an informed consent prior to entering the study.
Must be 18 years of age or older
Good general and mental health with, in the opinion of the investigator or their medically qualified designee, no clinically relevant or significant abnormalities found on examination of the oral cavity or in their medical history.
Participant with a Challacombe Scale score of 1 or higher
Participant agrees not to eat, drink, chew tobacco, chew gum, smoke, brush or floss their teeth for 2 hours prior to study visits
Participant agrees not to use any oral care products or any type of breath mint or lozenges for 2 hours prior to study visits
Participant agrees not to consume any food or liquid during the study visits, except for what is provided by the study research staff (e.g., water and treatments A and B during evaluation periods)
Participant agrees to using clinical oral care supplies provided by the investigators and no other products during the entire study
Understands and is willing and able to comply with all study procedures and restrictions

Exclusion Criteria

Women who are pregnant or intending to become pregnant over the course of the study, or who are found to have a positive urine pregnancy test at the Screening Visit
Women who are breast-feeding
Participant is currently undergoing radiotherapy and/or chemotherapy.
Any condition the investigator identifies that may impede the participant's ability to properly participate in the study. For example, Alzheimer's Disease
Participant with untreated oral mucosal disease which in the opinion of the investigator could interfere with the study. For example, presence of oral ulceration.
Evidence of gross intra-oral neglect or need for extensive dental therapy
Denture wearer (complete dentures)
Participant on systemic parasympathetic medications (e.g. pilocarpine) for treating dry mouth, but the dose requirement of which is unstable
Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or to any of their stated ingredients
Participation in another clinical study (including studies of cosmetic products) or in receipt of an investigational drug within 14 days of the screening visit
Previous participation in this study
Recent history (within one year prior to screening visit) of alcohol or other substance abuse

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
MucoPEG	MucoPEG	Arm being compared to against Biotene
Biotene	Biotene	Arm being compared against MucoPEG

Primary Outcome Measures

Name	Time	Method
Change in VAS for Mouth Dryness	baseline and 2 weeks, value at 2weeks minus value at baseline	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).
Dry Mouth Relief Questionnaires (DMRQ)	2 weeks(at last visit)	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.
Change in VAS for Tongue Dryness	baseline and 2 weeks, value at 2weeks minus value at baseline	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).

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Treatment-related Adverse Events as Evaluated by the Principal Investigator	2 weeks	To evaluate the clinical safety of MucoPEG. Patient reported outcomes will be evaluated by the Principal Investigator.
Dry Mouth Inventory (DMI) Questionnaire.	2 weeks	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.

Trial Locations

Locations (2): Tufts University School of Dental Medicine
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Boston, Massachusetts, United States
ColoradoENT
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Colorado Springs, Colorado, United States