Clinical Evaluation of MucoPEG™ for Xerostomia

NCT04986501 | Completed Results FDA Device

• 1 other identifier: SB-MU-001
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 2

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.

Conditions

Dry Mouth; Xerostomia

Keywords

Dry mouth; Xerostomia; Cotton mouth

Outcome Measures

Primary Outcomes (3)

• 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).

  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.

  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).

  baseline and 2 weeks, value at 2weeks minus value at baseline

Secondary Outcomes (2)

• Number of Participants With Treatment-related Adverse Events as Evaluated by the Principal Investigator

  2 weeks

• Dry Mouth Inventory (DMI) Questionnaire.

  2 weeks

Study Arms (2)

MucoPEG

EXPERIMENTAL

Arm being compared to against Biotene

Device: MucoPEG

Biotene

ACTIVE COMPARATOR

Arm being compared against MucoPEG

Device: Biotene

Interventions

MucoPEG DEVICE

Experimental

MucoPEG

Biotene DEVICE

Active Comparator

Biotene

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• SunBio, Inc.: lead
• NAMSA: collaborator
• Rudacure: collaborator

Study Sites (2)

ColoradoENT

Colorado Springs, Colorado, 80923, United States

Location

Tufts University School of Dental Medicine

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

Xerostomia

Condition Hierarchy (Ancestors)

Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases

Results Point of Contact

• Title: Min-Jung Ahn
• Organization: Sunbio

mjahn@sunbio.com

+82-31-423-5467

Study Officials

• To be determined To be determined, DDS

  Study Site

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study is a randomized, open-labelled crossover trial.

Study Record Dates

• First Submitted: July 8, 2021
• First Posted: August 2, 2021
• Study Start: May 2, 2022
• Primary Completion: September 15, 2022
• Study Completion: November 15, 2022
• Last Updated: May 23, 2025
• Results First Posted: May 23, 2025

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)