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

NCT04901507 | Completed Results FDA Device

• 1 other identifier: HM20021188
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Xerostomia

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (1)

The Voutia System

EXPERIMENTAL

The Voutia System oral irrigation device

Device: The Voutia System

Interventions

The Voutia System DEVICE

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.

Also known as: Oral irrigation device

The Voutia System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients who report xerostomia (dry mouth) and are diagnosed after testing with hypofunctioning salivary glands

You may not qualify if:

• Patient who after testing do not exhibit salivary hypofunction
• Children
• Patient with limited English proficiency

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• Voutia: collaborator

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Xerostomia

Condition Hierarchy (Ancestors)

Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases

Results Point of Contact

• Title: Dr. Caroline Carrico
• Organization: Virginia Commonwealth University School of Dentistry

ckcarrico@vcu.edu

804-828-8328

Study Officials

• Susie Goolsby, DDS, MSHA

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2021
• First Posted: May 25, 2021
• Study Start: May 20, 2021
• Primary Completion: April 28, 2022
• Study Completion: April 28, 2022
• Last Updated: July 24, 2023
• Results First Posted: July 24, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)