CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 39 enrolled
Drug / intervention
HYDRAL Oral Rinse +2 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04289051
NCT04289051N/ACompleted

Clinical Evaluation of the Efficacy of an Intra Oral Rinse for Patients With Xerostomia

Sunstar Americas·interventional·Posted Feb 28, 2020·Updated Feb 24, 2022

In Brief

A clinical study evaluating HYDRAL Oral Rinse, BIOTENE® Oral Rinse, and 1 other intervention for Xerostomia. Completed, enrolled 39 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsXerostomia
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedFeb 28, 2020
Enrollment StartAug 19, 2020
Primary CompletionFeb 4, 2021
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 6.3 years ago

Interventions

HYDRAL Oral Rinsedevice

Application 4 times a day for two weeks

BIOTENE® Oral Rinsedevice

Application 4 times a day for two weeks

Placebo Oral Rinsedevice

Application 4 times a day for two weeks