Effects of an External Oral Irrigation Device on Patients With Dry Mouth

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of an External Oral Irrigation Device on Patients With Dry Mouth

Conditions
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Xerostomia

Intervention / Treatment
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* Device: The Voutia System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The Voutia System<br>The Voutia System oral irrigation device | Device: The Voutia System<br>* 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.<br>* Other names: Oral irrigation device;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Baseline to 4 - 6 weeks | 
| 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. | Baseline to 4 - 6 weeks | 
| 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. | Baseline to 4 - 6 weeks | 
| 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. | Baseline to 4 - 6 weeks | 
| 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. | Baseline to 4 - 6 weeks |