Skip to main content
OpenTrials
Completed

NCT Number: NCT04901507

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Xerostomia Mouth Diseases Salivary Gland Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

About this study

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:

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Oral irrigation device

Primary outcomes

  1. Change in Oral Health Related Quality of Life (OHRQoL)

    Time frame: 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

  2. Change in Oral Health Related Quality of Life - Dry Mouth Specific (OHRQoL-XI)

    Time frame: 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.

  3. Change in Oral Dryness

    Time frame: 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.

  4. Clinical Changes in Stimulated Saliva Flow

    Time frame: 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.

  5. Clinical Changes in Unstimulated Saliva Flow

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Collaborators

  • Voutia

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 25, 2021
Registry last updated
Jul 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.