NCT04289051

Clinical Evaluation of Oral Rinse for Xerostomia

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Sunstar Americas · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Xerostomia

Interventions

Type	Name	Description
DEVICE	HYDRAL Oral Rinse	Application 4 times a day for two weeks
DEVICE	BIOTENE® Oral Rinse	Application 4 times a day for two weeks
DEVICE	Placebo Oral Rinse	Application 4 times a day for two weeks

Timeline

• Start date: 2020-08-19
• Primary completion: 2021-02-04
• Completion: 2021-02-04
• First posted: 2020-02-28
• Last updated: 2022-02-24
• Results posted: 2022-02-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study