Clinical Evaluation of MucoPEG™ for Xerostomia

Study Overview
=================
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.

Official Title
-----------------
Clinical Evaluation of MucoPEG™ for Xerostomia

Conditions
-----------------
Dry Mouth, Xerostomia

Intervention / Treatment
-----------------
* Device: MucoPEG
* Device: Biotene


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: The study is a randomized, open-labelled crossover trial.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MucoPEG<br>Arm being compared to against Biotene | Device: MucoPEG<br>* Experimental<br>|
| Active Comparator: Biotene<br>Arm being compared against MucoPEG | Device: Biotene<br>* Active Comparator<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale (VAS) | 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 | Prior to product use, first day of treatment period, after the last dose of the product used and on the final day of treatment period. | 
| Dry Mouth Relief Questionnaires (DMRQ) | 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 Dry Mouth Relief Questionnaires (DMRQ). | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Product Use Questionnaire (PPUQ) | To demonstrate effectiveness of MucoPEG in treating symptoms of dry mouth to that of Biotene. Effectiveness will be assessed using dry mouth Product Use Questionnaire (PPUQ). | 2 weeks | 
| Product Performance and Attributes Questionnaire (PPAQ) | To demonstrate effectiveness of MucoPEG in treating symptoms of dry mouth to that of Biotene. Effectiveness will be assessed using dry mouth Product Performance and Attributes Questionnaire (PPAQ) | 2 weeks | 
| 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. | 2 weeks | 
| Change in Xerostomia using the Dry Mouth Inventory (DMI) questionnaire. | To examine change in Xerostomia using the Dry Mouth Inventory (DMI). Using a scale from Disagree (0) to Strongly agree (3) | 2 weeks | 
| Visual Analogue Scale (VAS) | To assess the effectiveness of MucoPEG in relieving xerostomia. Effectiveness will be addressed using the Visual Analogue Scale (VAS). Where 0 is Not Dry at All and 10 is Very Dry | 2 hours and 1 week of use | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dry mouth, Xerostomia, Cotton mouth