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

NCT ID: NCT03281486

Last Updated: 2021-08-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-28
• Study Completion Date: 2019-12-31

Brief 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

Dry Mouth; Xerostomia; Type 2 Diabetics

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

HA formulation Oral Spray

Subjects will be instructed to mouth spray with 0.3 ml ( 2 sprays to the mouth) of their assigned mouth spray, 2 times daily (morning and evening), using only the assigned mouth spray provided for the 4 week duration of the study.

Group Type: EXPERIMENTAL

HA formulation Oral Spray

Intervention Type: DEVICE

It is an HA formulation of FDA listed ingredients

Placebo Oral Spray

Subjects will be instructed to mouth spray with 0.3 ml ( 2 sprays to the mouth) of their assigned mouth spray, 2 times daily (morning and evening), using only the assigned mouth spray provided for the 4 week duration of the study.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DEVICE

Placebo formulation without the active ingredients

Interventions

Placebo

Placebo formulation without the active ingredients

Intervention Type: DEVICE

HA formulation Oral Spray

It is an HA formulation of FDA listed ingredients

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

You First Services

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Division of Endocrinology and Metabolism, Saint Louis University

St Louis, Missouri, United States

Countries

United States

Other Identifiers

LUD-105-17

Identifier Type: -

Identifier Source: org_study_id