Clinical trial NCT04986501: Clinical Evaluation of MucoPEG™ for Xerostomia
Official title: Clinical Evaluation of MucoPEG™ for Xerostomia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Mouth
Xerostomia
Keywords: Dry mouth
Xerostomia
Cotton mouth
Lead sponsor: SunBio, Inc.
Sponsor class: INDUSTRY
Collaborators: name: NAMSA
name: Rudacure
First posted: 2021-08-02
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The study is a randomized, open-labelled crossover trial.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Must have read, understood and signed an informed consent prior to entering the study.
2. Must be 18 years of age or older
3. 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.
4. Participant with a Challacombe Scale score of 1 or higher
5. Participant agrees not to eat, drink, chew tobacco, chew gum, smoke, brush or floss their teeth for 2 hours prior to study visits
6. Participant agrees not to use any oral care products or any type of breath mint or lozenges for 2 hours prior to study visits
7. 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)
8. Participant agrees to using clinical oral care supplies provided by the investigators and no other products during the entire study
9. Understands and is willing and able to comply with all study procedures and restrictions

Exclusion Criteria:

1. 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
2. Women who are breast-feeding
3. Participant is currently undergoing radiotherapy and/or chemotherapy.
4. Any condition the investigator identifies that may impede the participant's ability to properly participate in the study. For example, Alzheimer's Disease
5. Participant with untreated oral mucosal disease which in the opinion of the investigator could interfere with the study. For example, presence of oral ulceration.
6. Evidence of gross intra-oral neglect or need for extensive dental therapy
7. Denture wearer (complete dentures)
8. Participant on systemic parasympathetic medications (e.g. pilocarpine) for treating dry mouth, but the dose requirement of which is unstable
9. Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or to any of their stated ingredients
10. Participation in another clinical study (including studies of cosmetic products) or in receipt of an investigational drug within 14 days of the screening visit
11. Previous participation in this study
12. Recent history (within one year prior to screening visit) of alcohol or other substance abuse

Primary outcomes:
measure: Change in VAS for Mouth Dryness
timeFrame: baseline and 2 weeks, value at 2weeks minus value at baseline
measure: Dry Mouth Relief Questionnaires (DMRQ)
timeFrame: 2 weeks(at last visit)
measure: Change in VAS for Tongue Dryness
timeFrame: baseline and 2 weeks, value at 2weeks minus value at baseline
Secondary outcomes:
measure: Number of Participants With Treatment-related Adverse Events as Evaluated by the Principal Investigator
timeFrame: 2 weeks
measure: Dry Mouth Inventory (DMI) Questionnaire.
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Colorado Springs
country: United States
facility: ColoradoENT
state: Colorado
city: Boston
country: United States
facility: Tufts University School of Dental Medicine
state: Massachusetts
Study officials:
affiliation: Study Site
name: To be determined To be determined, DDS
role: PRINCIPAL_INVESTIGATOR
References: