N/A
N=16
Effects of an External Oral Irrigation Device on Patients With Dry Mouth
Xerostomia
Bottom Line
View on ClinicalTrials.gov: NCT04901507 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Jul 2023
Primary outcome: Primary: Change in Oral Health Related Quality of Life (OHRQoL) — 10.2 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- The Voutia System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Virginia Commonwealth University
- Primary completion
- Apr 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Oral Health Related Quality of Life (OHRQoL) |
10.2 | — |
| PRIMARY Change in Oral Health Related Quality of Life - Dry Mouth Specific (OHRQoL-XI) |
13.2 | — |
| PRIMARY Change in Oral Dryness |
0.85 | — |
| PRIMARY Clinical Changes in Stimulated Saliva Flow |
0.73 | — |
| PRIMARY Clinical Changes in Unstimulated Saliva Flow |
5.7 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04901507). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.