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

NCT03281486 | Completed DMC FDA Device

• 1 other identifier: LUD-105-17
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

HA formulation Oral Spray

EXPERIMENTAL

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

Placebo Oral Spray

PLACEBO COMPARATOR

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

Interventions

HA formulation Oral Spray DEVICE

It is an HA formulation of FDA listed ingredients

HA formulation Oral Spray

Placebo DEVICE

Placebo formulation without the active ingredients

Placebo Oral Spray

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient should be above 18 years of age.
• Patients who have been diagnosed with type 2 diabetes and have developed dry mouth or have worsening of pre-existing dry mouth condition.
• Ability to attend visits at the research site
• Patient should be able to read and/or understand and sign the consent form and be willing to participate in the research study
• Agree to abstain from the use of any products for xerostomia other than those provided in the study.
• Agree to comply with the conditions and schedule of the study.

You may not qualify if:

• Subjects with open mouth sores at study entry.
• Any pathology that, based on the judgement of the researcher, could negatively affect the oral mucosa and subsequent treatment for xerostomia.
• Subjects who are nursing, becoming pregnant or plan to become pregnant during the study period
• Subjects currently on medication or treatment for dry mouth/xerostomia
• Hypersensitivity to any of the following ingredients- HA ,xylitol and Sodium Benzoate.
• Subjects with soft or hard tissue tumor of the oral cavity.
• Presence of severe gingivitis.
• Chronic disease with concomitant oral manifestations other than xerostomia
• History of radiation therapy to head and neck
• Subjects with conditions the investigator may feel will interfere with the study.

Sponsors & Collaborators

• You First Services: lead

Study Sites (1)

Division of Endocrinology and Metabolism, Saint Louis University

St Louis, Missouri, 63104, United States

Location

MeSH Terms

Conditions

Xerostomia

Condition Hierarchy (Ancestors)

Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2017
• First Posted: September 13, 2017
• Study Start: January 28, 2018
• Primary Completion: October 31, 2019
• Study Completion: December 31, 2019
• Last Updated: August 10, 2021

Record last verified: 2021-08

Locations

US (1)