Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Artificial Saliva in Diabetes Type II: a Randomized Registry Cross Over Study
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 follow a three day treatment with each product. Whereas after the first treatment
period the two groups had to follow a wash out period of three days before the second
treatment period could begin.
The artificial saliva spray reduced the xerostomia and the inflammation or the oral tissue.
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 conformity with the guidelines of the Declaration of Helsinki.
The type of study was a randomized, cross over clinical trial to compare two treatments
(artificial saliva spray (aldiamed(R) mouth spray) AS vs. (Tonimer(R) Throat Spray) TT .
Twenty one subjects that were part of the epidemiological screening for asymptomatic vascular
diseases conducted in the Irwin Lab3 of Spoltore (PE / Italy) The degree of xerostomia for
the admission had to be at least > 2 according to a semi-quantal scale (ranging from 0 to 6)
and patients already under treatment for xerostomia or with xerostomia score < 2, suffering
from obesity, cancer, drug addiction or alcoholism were excluded.
The patients had to follow a three day treatment with each product. Whereas after the first
treatment period the two groups had to follow a wash out period of three days before the
second treatment period could begin.
The study consisted of a preliminary selection during screening, the measurement of
xerostomia and random allocation, first treatment period, wash out period and finally the
second treatment period.
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