"Hyaluronan" Formulation for Type 2 Diabetic Patients With Dry Mouth

Xerostomia Clinical Trial

Official title:

Clinical Evaluation of the Efficacy of "Hyaluronan" Formulation for Dry Mouth in Patients With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03281486
• Other study ID #: LUD-105-17
• Status: Completed
• Phase: N/A
• Start date: January 28, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: August 2021
• Source: You First Services
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 31, 2019
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patient should be above 18 years of age.

2. Patients who have been diagnosed with type 2 diabetes and have developed dry mouth or have worsening of pre-existing dry mouth condition.

3. Ability to attend visits at the research site

4. Patient should be able to read and/or understand and sign the consent form and be willing to participate in the research study

5. Agree to abstain from the use of any products for xerostomia other than those provided in the study.

6. Agree to comply with the conditions and schedule of the study.

Exclusion Criteria:

1. Subjects with open mouth sores at study entry.

2. Any pathology that, based on the judgement of the researcher, could negatively affect the oral mucosa and subsequent treatment for xerostomia.

3. Subjects who are nursing, becoming pregnant or plan to become pregnant during the study period

4. Subjects currently on medication or treatment for dry mouth/xerostomia

5. Hypersensitivity to any of the following ingredients- HA ,xylitol and Sodium Benzoate.

6. Subjects with soft or hard tissue tumor of the oral cavity.

7. Presence of severe gingivitis.

8. Chronic disease with concomitant oral manifestations other than xerostomia

9. History of radiation therapy to head and neck

10. Subjects with conditions the investigator may feel will interfere with the study.

Related Conditions & MeSH terms

• Dry Mouth
• Type 2 Diabetics
• Xerostomia

Intervention

Device:
• HA formulation Oral Spray
It is an HA formulation of FDA listed ingredients
• Placebo
Placebo formulation without the active ingredients

Locations

Country	Name	City	State
United States	Division of Endocrinology and Metabolism, Saint Louis University	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
You First Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relief from drymouth using VAS scoring	Patients' perception of efficacy of a new mouth spray for 9 weeks in reducing the symptoms of drymouth in diabetic patients using VAS scoring	9 weeks