Effects of an External Oral Irrigation Device on Patients With Dry Mouth
Primary Purpose
Xerostomia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
The Voutia System
Sponsored by
About this trial
This is an interventional treatment trial for Xerostomia
Eligibility Criteria
Inclusion Criteria:
- patients who report xerostomia (dry mouth) and are diagnosed after testing with hypofunctioning salivary glands
Exclusion Criteria:
- Patient who after testing do not exhibit salivary hypofunction
- Children
- Patient with limited English proficiency
Sites / Locations
- Virginia Commonwealth University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
The Voutia System
Arm Description
The Voutia System oral irrigation device
Outcomes
Primary Outcome Measures
Change in Oral Health Related Quality of Life (OHRQoL)
OHRQoL will be assess using the Oral Health Impact Profile (OHIP-14). The OHIP-14 scores can range from 0 to 56 and are calculated by summing the ordinal values for the 14 items on the scale. Higher OHIP-14 scores indicate worse and lower scores indicate better OHRQol
Change in Oral Health Related Quality of Life - Dry Mouth Specific (OHRQoL-XI)
OHRQoL-XI will be assessed using the Xerostomia Inventory (XI), an 11-item summated rating scale which combines the responses to 11 individual items into a single continuous scale score which represents the severity of chronic xerostomia. Scores range from 11 to 55 with higher scores represent more severe symptoms.
Change in Oral Dryness
Clinical Oral Dryness Score (CODS) conducted during the clinical exam assesses ten key features of dry mouth and allocates one point for each feature. The total score ranges from 0 to 10 with higher scores indicating more severe dry mouth.
Clinical Changes in Stimulated Saliva Flow
Data on routine stimulated saliva testing as performed as standard of care for patients suspected to have reduced salivary flow will be compared before and after use of the device.
Clinical Changes in Unstimulated Saliva Flow
Data on routine unstimulated saliva testing as performed as standard of care for patients suspected to have reduced salivary flow will be compared before and after use of the device.
Secondary Outcome Measures
Full Information
NCT ID
NCT04901507
First Posted
May 19, 2021
Last Updated
June 30, 2023
Sponsor
Virginia Commonwealth University
Collaborators
Voutia
1. Study Identification
Unique Protocol Identification Number
NCT04901507
Brief Title
Effects of an External Oral Irrigation Device on Patients With Dry Mouth
Official Title
Effects of an External Oral Irrigation Device on Patients With Dry Mouth
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
May 20, 2021 (Actual)
Primary Completion Date
April 28, 2022 (Actual)
Study Completion Date
April 28, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
Collaborators
Voutia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
The purpose of this research study is to test the effectiveness of treating dry mouth through water rehydration using this extra oral water pump/irrigation device.
Detailed Description
Dry mouth causes difficulty with chewing, swallowing, speech, and increases the risk dental cavities. It also can cause discomfort in the mouth, and a loss of general quality of life. The oral irrigation device supplies a small amount of water to participant's mouth through a small tube that is placed in the corner of the mouth throughout the time participants wear it.
In this study, participants will be asked to:
Visit the dental school clinic two (2) times for study visits.
Wear the oral irrigation device as directed by the investigator.
Keep notes at home.
Answer survey questions during both dental visits about dry mouth symptoms.
Give permission for the researchers to collect information about medications or health conditions that contribute to dry mouth from participant's medical records.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Xerostomia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
The Voutia System
Arm Type
Experimental
Arm Description
The Voutia System oral irrigation device
Intervention Type
Device
Intervention Name(s)
The Voutia System
Other Intervention Name(s)
Oral irrigation device
Intervention Description
Participants will wear the Voutia System oral irrigation device continuously through the day and night, removing for cleaning and if otherwise necessary, but not for time extending beyond six-eight hours.
Primary Outcome Measure Information:
Title
Change in Oral Health Related Quality of Life (OHRQoL)
Description
OHRQoL will be assess using the Oral Health Impact Profile (OHIP-14). The OHIP-14 scores can range from 0 to 56 and are calculated by summing the ordinal values for the 14 items on the scale. Higher OHIP-14 scores indicate worse and lower scores indicate better OHRQol
Time Frame
Baseline to 4 - 6 weeks
Title
Change in Oral Health Related Quality of Life - Dry Mouth Specific (OHRQoL-XI)
Description
OHRQoL-XI will be assessed using the Xerostomia Inventory (XI), an 11-item summated rating scale which combines the responses to 11 individual items into a single continuous scale score which represents the severity of chronic xerostomia. Scores range from 11 to 55 with higher scores represent more severe symptoms.
Time Frame
Baseline to 4 - 6 weeks
Title
Change in Oral Dryness
Description
Clinical Oral Dryness Score (CODS) conducted during the clinical exam assesses ten key features of dry mouth and allocates one point for each feature. The total score ranges from 0 to 10 with higher scores indicating more severe dry mouth.
Time Frame
Baseline to 4 - 6 weeks
Title
Clinical Changes in Stimulated Saliva Flow
Description
Data on routine stimulated saliva testing as performed as standard of care for patients suspected to have reduced salivary flow will be compared before and after use of the device.
Time Frame
Baseline to 4 - 6 weeks
Title
Clinical Changes in Unstimulated Saliva Flow
Description
Data on routine unstimulated saliva testing as performed as standard of care for patients suspected to have reduced salivary flow will be compared before and after use of the device.
Time Frame
Baseline to 4 - 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients who report xerostomia (dry mouth) and are diagnosed after testing with hypofunctioning salivary glands
Exclusion Criteria:
Patient who after testing do not exhibit salivary hypofunction
Children
Patient with limited English proficiency
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susie Goolsby, DDS, MSHA
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of an External Oral Irrigation Device on Patients With Dry Mouth
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