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

Virginia Commonwealth University (VCU)

Status: Completed

Conditions: Xerostomia

Treatments: Device: The Voutia System

Study type: Interventional

Funder types: Other

Identifiers

NCT04901507

HM20021188

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

The Voutia System

Experimental group

Description:

The Voutia System oral irrigation device

Treatment:

Device: The Voutia System