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Clinical Evaluation of MucoPEG™ for Xerostomia

NCT04986501 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2025-05-23

Study results available
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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

Interventions

DEVICE

MucoPEG

Experimental

DEVICE

Biotene

Active Comparator

Sponsors & Collaborators

  • NAMSA

    collaborator OTHER

  • Rudacure

    collaborator INDUSTRY

  • SunBio, Inc.

    lead INDUSTRY

Principal Investigators

  • To be determined To be determined, DDS · Study Site

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-02
Primary Completion
2022-09-15
Completion
2022-11-15
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04986501 on ClinicalTrials.gov