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| Name | Class |
|---|---|
| Voutia | INDUSTRY |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The Voutia System | Experimental | The Voutia System oral irrigation device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susie Goolsby, DDS, MSHA | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline to 4 - 6 weeks |
|
Study subjects utilized the Voutia device for a period of approximately 2 months during which time adverse events were monitored.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Caroline Carrico | Virginia Commonwealth University School of Dentistry | 804-828-8328 | ckcarrico@vcu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 1, 2021 | May 19, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 1, 2021 | Jun 29, 2023 | SAP_003.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 1, 2021 | May 19, 2023 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D014987 | Xerostomia |
| ID | Term |
|---|---|
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
|
| CODS | Clinical Oral Dryness Score- a clinician scored features observed in the patient's mouth and derived a COD score of 0-10. Clinical findings observed were given a one-point value towards the CODS, with 10 indicating the most severe oral dryness. | Three subjects withdrew prior to baseline outcome measures being recorded. Three subjects withdrew prior to baseline outcome measures being recorded. | Mean | Standard Deviation | units on a scale |
|
| OHIP | Oral Health Impact Profile (OHIP-14) used to measure Oral Health-Related Quality of Life (OHRQoL) | Three subjects withdrew prior to baseline outcome measures being recorded. | Mean | Standard Deviation | units on a scale |
|
| Xerostomia Inventory | Three subjects withdrew prior to baseline outcome measures being recorded. | Mean | Standard Deviation | units on a scale |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Primary | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline to 4 - 6 weeks |
|
|
|
| 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. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline to 4 - 6 weeks |
|
|
|
| Primary | 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. | Posted | Mean | 95% Confidence Interval | mL/min | Baseline to 4 - 6 weeks |
|
|
|
| Primary | 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. | Posted | Mean | 95% Confidence Interval | mL/min | Baseline to 4 - 6 weeks |
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| 0 |
| 16 |
| 0 |
| 16 |
| 0 |
| 16 |
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