Trials / Completed
CompletedNCT03663231
Duration of Effect of Biotene Spray in Patients With Dry Mouth
Duration of Effect of Biotene Spray in Patients With Symptomatic Dry Mouth
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 37 (actual)
- Sponsor
- University of Rochester · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To determine the duration of effect of a single dose of Biotène Moisturizing Mouth Spray in subjects who complain of a clinically dry mouth. The effect of the product will be compared to a control spray (water).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Biotene | Biotène Dry Mouth Moisturizing Spray contains water, polyglycitol, propylene glycol, sunflower oil, xylitol, milk protein extract, potassium sorbate, acesulfame K, potassium thiocyanate, lysozyme, lactoferrin, lactoperoxidase. 3 sprays, approximately 15 mL. |
| DEVICE | Placebo | IND/IDE exempt device primarily water |
Timeline
- Start date
- 2019-02-11
- Primary completion
- 2019-11-22
- Completion
- 2019-11-22
- First posted
- 2018-09-10
- Last updated
- 2021-01-20
- Results posted
- 2021-01-20
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03663231. Inclusion in this directory is not an endorsement.