NCT04901507

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Virginia Commonwealth University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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: 1. Visit the dental school clinic two (2) times for study visits. 2. Wear the oral irrigation device as directed by the investigator. 3. Keep notes at home. 4. Answer survey questions during both dental visits about dry mouth symptoms. 5. Give permission for the researchers to collect information about medications or health conditions that contribute to dry mouth from participant's medical records.

Conditions

• Xerostomia

Interventions

Type	Name	Description
DEVICE	The Voutia System	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.

Timeline

• Start date: 2021-05-20
• Primary completion: 2022-04-28
• Completion: 2022-04-28
• First posted: 2021-05-25
• Last updated: 2023-07-24
• Results posted: 2023-07-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study