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

Xerostomia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04901507
• Other study ID #: HM20021188
• Status: Completed
• Phase: N/A
• Start date: May 20, 2021
• Est. completion date: April 28, 2022

Study information

• Verified date: June 2023
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: April 28, 2022
• Est. primary completion date: April 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Xerostomia

Intervention

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.

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	Voutia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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