Clinical Evaluation of MucoPEG™ for Xerostomia

NCT ID: NCT04986501

Last Updated: 2025-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-02
• Study Completion Date: 2022-11-15

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.

Conditions

Dry Mouth; Xerostomia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MucoPEG

Arm being compared to against Biotene

Group Type: EXPERIMENTAL

MucoPEG

Intervention Type: DEVICE

Experimental

Biotene

Arm being compared against MucoPEG

Group Type: ACTIVE_COMPARATOR

Biotene

Intervention Type: DEVICE

Active Comparator

Interventions

MucoPEG

Experimental

Intervention Type: DEVICE

Biotene

Active Comparator

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

NAMSA

OTHER

Sponsor Role: collaborator

Rudacure

INDUSTRY

Sponsor Role: collaborator

SunBio, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

To be determined To be determined, DDS

Role: PRINCIPAL_INVESTIGATOR

Study Site

Locations

ColoradoENT

Colorado Springs, Colorado, United States

Tufts University School of Dental Medicine

Boston, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

SB-MU-001

Identifier Type: -

Identifier Source: org_study_id