Dry Mouth, Xerostomia
Conditions
Keywords
Dry mouth, Xerostomia, Cotton mouth
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.
Interventions
DEVICEMucoPEG
Experimental
DEVICEBiotene
Active Comparator
Sponsors
NAMSA
Rudacure
SunBio, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The study is a randomized, open-labelled crossover trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in VAS for Mouth Dryness | 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) | 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 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-related Adverse Events as Evaluated by the Principal Investigator | 2 weeks | To evaluate the clinical safety of MucoPEG. Patient reported outcomes will be evaluated by the Principal Investigator. |
| Dry Mouth Inventory (DMI) Questionnaire. | 2 weeks | 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. |
Countries
United States
Participant flow
Recruitment details
The study prospectively enrolled 45 subjects from 2 investigational sites across the USA starting 3 MAY 2022. Twenty-two subjects were enrolled, with twenty-one completing the study at Tufts University School of Dental Medicine in Boston, MA, over approximately 42 days. Twenty-three subjects were enrolled, with twenty-one completing the study at Colorado ENT & Allergy in Colorado Springs, CO.
Pre-assignment details
42 subjects were randomized. 3 subjects were not randomized. why the subjects (n = 3) exited the study early, were screen failure, withdrawal of consent, and lost of follow-up before randomization.
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants Participant will be randomly allocated to either MucoPEG or Biotene in this crossover study in a 1:1 ratio. Participants first received MucoPEG or Biotene for 2 weeks. After a washout period of 1 weeks, they then received Biotene or MucoPEG for 2 weeks. | 42 |
| Total | 42 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 19 Participants |
| Age, Categorical Between 18 and 65 years | 23 Participants |
| Challacombe Scale Score | 3.3 units on a scale STANDARD_DEVIATION 1.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 36 Participants |
| Region of Enrollment United States | 42 participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 42 | 0 / 42 |
| other Total, other adverse events | 1 / 42 | 2 / 42 |
| serious Total, serious adverse events | 0 / 42 | 0 / 42 |
Outcome results
Primary
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).
Time frame: baseline and 2 weeks, value at 2weeks minus value at baseline
Population: Patients will be randomly allocated to either group A or group B in this crossover study in a 1:1 ratio. Patients in group A will begin using MucoPEG from Visit 2 for two weeks (period 1). This is followed by a washout period of one week. They will switch to using Biotène® Dry Mouth Gentle Oral Rinse from Visit 5 for another two weeks (period 2). Patients in group B will follow the same pattern except they receive Biotène® Dry Mouth Gentle Oral Rinse in period 1 and MucoPEG in period 2.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MucoPEG | Change in VAS for Mouth Dryness | Period 1 | -0.8 score on a scale | Standard Deviation 2 |
| MucoPEG | Change in VAS for Mouth Dryness | Period 2 | -1.5 score on a scale | Standard Deviation 2.4 |
| Biotene | Change in VAS for Mouth Dryness | Period 1 | -0.7 score on a scale | Standard Deviation 3 |
| Biotene | Change in VAS for Mouth Dryness | Period 2 | -0.4 score on a scale | Standard Deviation 1.6 |
p-value: <0.01t-test, 1 sided
Primary
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).
Time frame: baseline and 2 weeks, value at 2weeks minus value at baseline
Population: Patients will be randomly allocated to either group A or group B in this crossover study in a 1:1 ratio. Patients in group A will begin using MucoPEG from Visit 2 for two weeks (period 1). This is followed by a washout period of one week. They will switch to using Biotène® Dry Mouth Gentle Oral Rinse from Visit 5 for another two weeks (period 2). Patients in group B will follow the same pattern except they receive Biotène® Dry Mouth Gentle Oral Rinse in period 1 and MucoPEG in period 2.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MucoPEG | Change in VAS for Tongue Dryness | Period 1 | -0.6 score on a scale | Standard Deviation 2.4 |
| MucoPEG | Change in VAS for Tongue Dryness | Period 2 | -1.4 score on a scale | Standard Deviation 2.4 |
| Biotene | Change in VAS for Tongue Dryness | Period 1 | -0.4 score on a scale | Standard Deviation 3.3 |
| Biotene | Change in VAS for Tongue Dryness | Period 2 | -0.2 score on a scale | Standard Deviation 1.3 |
p-value: <0.01t-test, 1 sided
Primary
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.
Time frame: 2 weeks(at last visit)
Population: Patients will be randomly allocated to either group A or group B in this crossover study in a 1:1 ratio. Patients in group A will begin using MucoPEG from Visit 2 for two weeks (period 1). This is followed by a washout period of one week. They will switch to using Biotène® Dry Mouth Gentle Oral Rinse from Visit 5 for another two weeks (period 2). Patients in group B will follow the same pattern except they receive Biotène® Dry Mouth Gentle Oral Rinse in period 1 and MucoPEG in period 2.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MucoPEG | Dry Mouth Relief Questionnaires (DMRQ) | 10 participants response with 4 or 5 score |
| Biotene | Dry Mouth Relief Questionnaires (DMRQ) | 11 participants response with 4 or 5 score |
Secondary
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.
Time frame: 2 weeks
Population: Patients will be randomly allocated to either group A or group B in this crossover study in a 1:1 ratio. Patients in group A will begin using MucoPEG from Visit 2 for two weeks (period 1). This is followed by a washout period of one week. They will switch to using Biotène® Dry Mouth Gentle Oral Rinse from Visit 5 for another two weeks (period 2). Patients in group B will follow the same pattern except they receive Biotène® Dry Mouth Gentle Oral Rinse in period 1 and MucoPEG in period 2.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MucoPEG | Dry Mouth Inventory (DMI) Questionnaire. | 9.4 score on a scale | Standard Deviation 5.3 |
| Biotene | Dry Mouth Inventory (DMI) Questionnaire. | 9.4 score on a scale | Standard Deviation 5.6 |
Secondary
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.
Time frame: 2 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MucoPEG | Number of Participants With Treatment-related Adverse Events as Evaluated by the Principal Investigator | 0 Participants |
| Biotene | Number of Participants With Treatment-related Adverse Events as Evaluated by the Principal Investigator | 0 Participants |