Status:
COMPLETED
The Artificial Saliva Spray Reduces Xerostomia in Diabetes Type II
Lead Sponsor:
Certmedica International GmbH
Conditions:
Xerostomia Due to Hyposecretion of Salivary Gland
Diabetes Mellitus, Type 2
Eligibility:
All Genders
30-75 years
Phase:
NA
Brief Summary
In diabetes Type II the xerostomia is a quite frequent symptom. In evaluating the activity of an artificial saliva spray compared to a water gel in patients with Diabetes Type II patients had to follo...
Detailed Description
In diabetes Type II the xerostomia is a quite frequent symptom. The trial was conducted at a single center. Designed and implementing UNI EN ISO 14155:2012, STROBE statement Version 4 and was in confo...
Eligibility Criteria
Inclusion
- suffering xerostomia
- degree of xerostomia at least \> 2 according to a semiquantal scare ranging from 0 to 6
- diabetes Type II \> one year, with stabilized oral hypoglycemic therapy from at least 6 months.
- concomitant chronic diseases pertaining to dyslipidemia, cardiovascular and/or gastrointestinal diseases, and anxiety/depression were accepted provided under adequate therapy since at least 6 months.
Exclusion
- under treatment for xerostomia or with xerostomia score \< 2
- suffering from obesity (BMI \> 30 kg/m2),
- cancer of any type
- drug addiction and alcoholism
Key Trial Info
Start Date :
September 23 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 16 2018
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT03452085
Start Date
September 23 2017
End Date
January 16 2018
Last Update
March 2 2018
Active Locations (1)
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1
Irwin Labs, University of Chieti
Chieti, PE, Italy, 65010