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

Not Applicable

Completed

Conditions: Xerostomia

Interventions: Device: The Voutia System

Registration Number: NCT04901507

Lead Sponsor: Virginia Commonwealth University

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:

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 16

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
The Voutia System	The Voutia System	The Voutia System oral irrigation device

Primary Outcome Measures

Name	Time	Method
Change in Oral Health Related Quality of Life (OHRQoL)	Baseline to 4 - 6 weeks	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
Clinical Changes in Unstimulated Saliva Flow	Baseline to 4 - 6 weeks	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.
Change in Oral Dryness	Baseline to 4 - 6 weeks	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.
Change in Oral Health Related Quality of Life - Dry Mouth Specific (OHRQoL-XI)	Baseline to 4 - 6 weeks	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.
Clinical Changes in Stimulated Saliva Flow	Baseline to 4 - 6 weeks	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.