N/A
Completed N=16
Effects of an External Oral Irrigation Device on Patients With Dry Mouth
Source: ClinicalTrials.gov NCT04901507 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Jul 2023
Primary outcomePrimary: Change in Oral Health Related Quality of Life (OHRQoL) — 10.2 score on a scale
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.
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 | — |
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. Informational only — not medical advice.