Trials / Completed
CompletedNCT03281486
"Hyaluronan" Formulation for Type 2 Diabetic Patients With Dry Mouth
Clinical Evaluation of the Efficacy of "Hyaluronan" Formulation for Dry Mouth in Patients With Type 2 Diabetes
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- You First Services · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
An increased incidence of dental caries in association with poorly controlled diabetes has also been reported, Xerostomia (dry mouth) has been reported to be a common complaint of patients with diabetes, Without adequate saliva production, both hard and soft tissues of the mouth can be severely damaged and become more susceptible to infections. This 9 week, cross-over group, randomized, single center, study will evaluate the efficacy of HA formulation in alleviating dry mouth in type 2 diabetic patients.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | HA formulation Oral Spray | It is an HA formulation of FDA listed ingredients |
| DEVICE | Placebo | Placebo formulation without the active ingredients |
Timeline
- Start date
- 2018-01-28
- Primary completion
- 2019-10-31
- Completion
- 2019-12-31
- First posted
- 2017-09-13
- Last updated
- 2021-08-10
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03281486. Inclusion in this directory is not an endorsement.