Trial Outcomes & Findings for Effects of an External Oral Irrigation Device on Patients With Dry Mouth (NCT NCT04901507)

NCT ID: NCT04901507

Last Updated: 2023-07-24

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

16 participants

Primary outcome timeframe

Baseline to 4 - 6 weeks

Results posted on

2023-07-24

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	16
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Three subjects withdrew prior to baseline outcome measures being recorded. Three subjects withdrew prior to baseline outcome measures being recorded.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	The Voutia System n=16 Participants 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.
Age, Categorical <=18 years	0 Participants n=16 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=16 Participants
Age, Categorical >=65 years	7 Participants n=16 Participants
Sex: Female, Male Female	10 Participants n=16 Participants
Sex: Female, Male Male	6 Participants n=16 Participants
Race/Ethnicity, Customized Race · Asian	1 Participants n=16 Participants
Race/Ethnicity, Customized Race · Black/African American	2 Participants n=16 Participants
Race/Ethnicity, Customized Race · White/Caucasian	13 Participants n=16 Participants
Region of Enrollment United States	16 Participants n=16 Participants
CODS	6.6 units on a scale STANDARD_DEVIATION 2.2 • n=13 Participants • Three subjects withdrew prior to baseline outcome measures being recorded. Three subjects withdrew prior to baseline outcome measures being recorded.
OHIP	33.1 units on a scale STANDARD_DEVIATION 14.05 • n=13 Participants • Three subjects withdrew prior to baseline outcome measures being recorded.
Xerostomia Inventory	46.4 units on a scale STANDARD_DEVIATION 9.06 • n=13 Participants • Three subjects withdrew prior to baseline outcome measures being recorded.

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	The Voutia System n=13 Participants 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.
Change in Oral Health Related Quality of Life (OHRQoL)	10.2 score on a scale Interval 0.07 to 20.24

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	The Voutia System n=13 Participants 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.
Change in Oral Health Related Quality of Life - Dry Mouth Specific (OHRQoL-XI)	13.2 score on a scale Interval 6.0 to 20.4

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	The Voutia System n=13 Participants 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.
Change in Oral Dryness	0.85 score on a scale Interval -0.04 to 1.73

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	The Voutia System n=13 Participants 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.
Clinical Changes in Stimulated Saliva Flow	0.73 mL/min Interval 0.11 to 1.36

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	The Voutia System n=13 Participants 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.
Clinical Changes in Unstimulated Saliva Flow	5.7 mL/min Interval -1.6 to 12.9

Adverse Events

The Voutia System

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Caroline Carrico

Virginia Commonwealth University School of Dentistry

Phone: 804-828-8328

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place