Status:
COMPLETED
"Hyaluronan" Formulation for Type 2 Diabetic Patients With Dry Mouth
Lead Sponsor:
You First Services
Conditions:
Dry Mouth
Xerostomia
Eligibility:
All Genders
18+ years
Phase:
NA
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 diabet...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 28 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2019
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03281486
Start Date
January 28 2018
End Date
December 31 2019
Last Update
August 10 2021
Active Locations (1)
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1
Division of Endocrinology and Metabolism, Saint Louis University
St Louis, Missouri, United States, 63104