N/A
N=39
Clinical Evaluation of Oral Rinse for Xerostomia
Xerostomia
Bottom Line
View on ClinicalTrials.gov: NCT04289051 ↗Enrolled (actual)
39
Serious AEs
0.0%
Results posted
Feb 2022
Primary outcome: Primary: Change in Dry Mouth Symptom by Visual Analog Scale at 14 Days From Baseline — 10.1; 11.6; 13.0 mm
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- HYDRAL Oral Rinse (Device); BIOTENE® Oral Rinse (Device); Placebo Oral Rinse (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sunstar Americas
- Primary completion
- Feb 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Dry Mouth Symptom by Visual Analog Scale at 14 Days From Baseline |
10.1; 11.6; 13.0 | — |
| PRIMARY Change in Dry Mouth Symptoms by Xerostomia Questionnaire at 14 Days From Baseline |
1.0; 0.4; 0.5 | — |
| SECONDARY Change in Oral Functions by Revised Oral Assessment Guide at 14 Days From Baseline |
2.0; 0; 1.2 | — |
| SECONDARY Change in Unstimulated Saliva Flow Rate at 14 Days From Baseline |
0.08; 0.00; 0.05 | — |
Summary
Xerostomia causes a difficulty in eating, have irritated oral tissues, and a poor quality of life. The new oral rinse was designed to reduce the symptoms and improve the patient's quality of life. The objectives of the clinical study is to evaluate the effectiveness of the oral rinse comparing to the placebo product and the control product in the market.
This is a randomized double-blind placebo controlled crossover study with 39 patients receiving treatment. Patients will be randomly allocated to three treatment groups. Patients will use the assigned oral rinse four times a day for two weeks. Dry mouth symptoms and other endpoints will be assessed subjectively and objectively at baseline and Day 14. Patients will be assigned to another treatment after one week wash-out period.
Eligibility Criteria
Inclusion Criteria
- Must have read, understood and signed an informed consent prior to being entered into the study.
- Must be 18 to 80 years of age, male or female.
- Have at least 20 natural or restored teeth.
- Have an unstimulated salivary flow rate 10 cigarettes/day
- Chewing tobacco
- Daily use of symptom alleviating products against xerostomia within 7 days of screening.
Data sourced from ClinicalTrials.gov (NCT04289051). 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.