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

Completed · Not applicable · Has a placebo group

Conditions studied: Dry Mouth, Xerostomia, Type 2 Diabetics

In brief

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.

Key facts

Study ID

NCT03281486

Run by

You First Services

People needed

30

Starts

2018-01-28

Expected to finish

2019-12-31

Last updated by the study team

2021-08-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

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

Full record on ClinicalTrials.gov

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