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

• Sponsor: You First Services (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03281486
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Actual Duration (Months): 23.1
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dry Mouth; Xerostomia; Type 2 Diabetics	Device: HA formulation Oral Spray; Device: Placebo	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Clinical Evaluation of the Efficacy of "Hyaluronan" Formulation for Dry Mouth in Patients With Type 2 Diabetes
• Actual Study Start Date: Jan 28, 2018
• Actual Primary Completion Date: Oct 31, 2019
• Actual Study Completion Date: Dec 31, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Relief from drymouth using VAS scoring [9 weeks]

   Patients' perception of efficacy of a new mouth spray for 9 weeks in reducing the symptoms of drymouth in diabetic patients using VAS scoring

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Division of Endocrinology and Metabolism, Saint Louis University	Saint Louis	Missouri	United States	63104

Sponsors and Collaborators

• You First Services

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: You First Services
• ClinicalTrials.gov Identifier: NCT03281486
• Other Study ID Numbers: LUD-105-17
• First Posted: Sep 13, 2017
• Last Update Posted: Aug 10, 2021
• Last Verified: Aug 1, 2021

• 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
• Additional relevant MeSH terms: Xerostomia

Study Results

No Results Posted as of Aug 10, 2021