Dry MouthCEMPEGNCT04986501
Clinical Evaluation of MucoPEG™ for Xerostomia
A study testing MucoPEG and Biotene in people with Dry Mouth and Xerostomia, run by SunBio, Inc. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dry Mouth, Xerostomia
- What is being tested?
- MucoPEG and Biotene
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 May 2022to 15 Nov 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Tufts University School of Dental Medicine
Boston, Massachusetts, 02111
ColoradoENT
Colorado Springs, Colorado, 80923
About this study
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.
Read the 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
- Being tested
- MucoPEG, Biotene
- Keywords
- Dry mouth, Xerostomia, Cotton mouth
- Medical subject headings
- Xerostomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MucoPEGDevice
Experimental
BioteneDevice
Active Comparator
| Study group | Role | What they receive |
|---|---|---|
| MucoPEG | Experimental | Arm being compared to against Biotene Receives: Device: MucoPEG |
| Biotene | Active comparator | Arm being compared against MucoPEG Receives: Device: Biotene |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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).
Measured: 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
To evaluate the clinical safety of MucoPEG. Patient reported outcomes will be evaluated by the Principal Investigator.
Measured: 2 weeks
Dry Mouth Inventory (DMI) Questionnaire.
To demonstrate the effectiveness using the Dry Mouth Inventory (DMI). There are 8 Dry Mouth Inventory (DMI) questionaires as follows. 1. My mouth feels dry, 2. I have difficulty eating dry foods, 3. I get up at night to drink, 4. My mouth feels dry when eating a meal, 5. I sip liquids to aid in swallowing food, 6. I suck sweets or cough lollies to relieve dry mouth, 7. My lips stick to the teeth, 8. My tongue sticks to the roof of my mouth.
Using a scale from "Disagree (0)" to "Strongly agree (3)". The scale has a minimum value of "0" and a maximum value of "24". The larger the scale, the more severe the dry mouth.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2021
- Study start2 May 2022
- Primary completion15 Sep 2022
- Study completion15 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dry MouthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The study is a randomized, open-labelled crossover trial.
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- SunBio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- NAMSA, Rudacure
- Responsible party
- Sponsor
- Investigators
- To be determined To be determined, DDS, Principal investigator, Study Site
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04986501
- Sponsor's protocol ID
- SB-MU-001
- Acronym
- CEMPEG
- Status last verified
- Jun 2024
- First submitted
- 8 Jul 2021
- Last updated
- 23 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of MucoPEG™ for Xerostomia
- ClinicalTrials.gov ID
- NCT04986501
- Acronym / sponsor ID
- CEMPEG / SB-MU-001
- Conditions
- Dry Mouth, Xerostomia
- Keywords
- Dry mouth, Xerostomia, Cotton mouth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- SunBio, Inc.Industry (pharma, biotech, devices)
- Collaborators
- NAMSA, Rudacure
- Study start
- 2 May 2022 (actual)
- Primary completion
- 15 Sep 2022 (actual)
- Study completion
- 15 Nov 2022 (actual)
- First posted
- 2 Aug 2021 (actual)
- Results
- Posted 23 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study is a randomized, open-labelled crossover trial.
| Arm | Type | Receives |
|---|---|---|
| MucoPEG | Experimental | Device: MucoPEGArm being compared to against Biotene |
| Biotene | Active comparator | Device: BioteneArm being compared against MucoPEG |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MucoPEGExperimental | Device | MucoPEG |
| BioteneActive Comparator | Device | Biotene |
Primary outcome
Change in VAS for Mouth Dryness
Time frame: baseline and 2 weeks, value at 2weeks minus value at baseline
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).
Dry Mouth Relief Questionnaires (DMRQ)
Time frame: 2 weeks(at last visit)
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.
Change in VAS for Tongue Dryness
Time frame: baseline and 2 weeks, value at 2weeks minus value at baseline
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).
2 secondary outcomes
Number of Participants With Treatment-related Adverse Events as Evaluated by the Principal Investigator
Time frame: 2 weeks
Dry Mouth Inventory (DMI) Questionnaire.
Time frame: 2 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Dry Mouth
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingObservational study
The Pathogenesis and Natural History of Sjogren's Disease
Sjogren's Syndrome, Salivary Gland
Recruiting
Evaluation of the Prevalence, and Immunological Characteristics of Small Fiber Neuropathy in Patients With Primary Sjögren's Syndrome
Sjögren's Syndrome, Small Fiber Neuropathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
To be determined To be determined, DDS principal investigator
Study Site
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MucoPEG and Biotene in people with Dry Mouth and Xerostomia, run by SunBio, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in VAS for Mouth Dryness (time frame: baseline and 2 weeks, value at 2weeks minus value at baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2025.