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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04901507

Enrollment

Registered

2021-05-25

Start date

2021-05-20

Completion date

2022-04-28

Last updated

2023-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Xerostomia

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.

Interventions

DEVICEThe 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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
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.
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.
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.
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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
The Voutia System The Voutia System oral irrigation 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.	16
Total	16

Baseline characteristics

Characteristic	The Voutia System
Age, Categorical <=18 years	0 Participants
Age, Categorical >=65 years	7 Participants
Age, Categorical Between 18 and 65 years	9 Participants
CODS	6.6 units on a scale STANDARD_DEVIATION 2.2
OHIP	33.1 units on a scale STANDARD_DEVIATION 14.05
Race/Ethnicity, Customized Race Asian	1 Participants
Race/Ethnicity, Customized Race Black/African American	2 Participants
Race/Ethnicity, Customized Race White/Caucasian	13 Participants
Region of Enrollment United States	16 Participants
Sex: Female, Male Female	10 Participants
Sex: Female, Male Male	6 Participants
Xerostomia Inventory	46.4 units on a scale STANDARD_DEVIATION 9.06

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 16
other Total, other adverse events	0 / 16
serious Total, serious adverse events	0 / 16

Outcome results

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.