Hyaluronan Formulation for Type 2 Diabetic Patients With Dry Mouth

Study Overview
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Brief Summary
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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.

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

Conditions
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Type 2 Diabetics, Dry Mouth, Xerostomia

Intervention / Treatment
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* Device: HA formulation Oral Spray
* Device: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HA formulation Oral Spray<br>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<br>* It is an HA formulation of FDA listed ingredients<br>|
| Placebo Comparator: Placebo Oral Spray<br>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<br>* Placebo formulation without the active ingredients<br>|

What is the study measuring?
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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 |