XerostomiaNCT04901507
Effects of an External Oral Irrigation Device on Patients With Dry Mouth
A study testing The Voutia System in people with Xerostomia, run by Virginia Commonwealth University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Xerostomia
- What is being tested?
- The Voutia System
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 20 May 2021to 28 Apr 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients who report xerostomia (dry mouth) and are diagnosed after testing with hypofunctioning salivary glands
Who cannot join
- Patient who after testing do not exhibit salivary hypofunction
- Children
- Patient with limited English proficiency
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
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.
Read the 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:
- 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.
- Conditions
- Xerostomia
- Being tested
- The Voutia System
- Medical subject headings
- Xerostomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Voutia SystemDevice
Also called Oral irrigation 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.
| Study group | Role | What they receive |
|---|---|---|
| The Voutia System | Experimental | The Voutia System oral irrigation device Receives: Device: The Voutia System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to 4 - 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2021
- Study start20 May 2021
- Primary completion28 Apr 2022
- Study completion28 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for XerostomiaStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- Voutia
- Responsible party
- Sponsor
- Investigators
- Susie Goolsby, DDS, MSHA, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04901507
- Sponsor's protocol ID
- HM20021188
- Status last verified
- Jun 2023
- First submitted
- 19 May 2021
- Last updated
- 24 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an External Oral Irrigation Device on Patients With Dry Mouth
- ClinicalTrials.gov ID
- NCT04901507
- Acronym / sponsor ID
- HM20021188
- Conditions
- Xerostomia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- Voutia
- Study start
- 20 May 2021 (actual)
- Primary completion
- 28 Apr 2022 (actual)
- Study completion
- 28 Apr 2022 (actual)
- First posted
- 25 May 2021 (actual)
- Results
- Posted 24 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The Voutia System | Experimental | Device: The Voutia SystemThe Voutia System oral irrigation device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients who report xerostomia (dry mouth) and are diagnosed after testing with hypofunctioning salivary glands
Key exclusion criteria (3 listed)
- Patient who after testing do not exhibit salivary hypofunction
- Children
- Patient with limited English proficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Voutia SystemAlso: Oral irrigation deviceParticipants 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. | Device | The Voutia System |
Primary outcome
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
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.
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.
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susie Goolsby, DDS, MSHA principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Voutia System in people with Xerostomia, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Oral Health Related Quality of Life (OHRQoL) (time frame: Baseline to 4 - 6 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2023.