"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

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.

Study Overview

• Status: Completed
• Conditions: Xerostomia; Dry Mouth; Type 2 Diabetics
• Intervention / Treatment: Device: Placebo; Device: HA formulation Oral Spray

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63104
      • Division of Endocrinology and Metabolism, Saint Louis University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Device: HA formulation Oral Spray; It is an HA formulation of FDA listed ingredients
PLACEBO_COMPARATOR: 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.	Device: Placebo; Placebo formulation without the active ingredients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: You First Services

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 28, 2018
• Primary Completion (ACTUAL): October 31, 2019
• Study Completion (ACTUAL): December 31, 2019

Study Registration Dates

• First Submitted: September 11, 2017
• First Submitted That Met QC Criteria: September 12, 2017
• First Posted (ACTUAL): September 13, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 10, 2021
• Last Update Submitted That Met QC Criteria: August 9, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Salivary Gland Diseases; Xerostomia
• Other Study ID Numbers: LUD-105-17

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No