An interventional study of artificial saliva spray (AS) and maritime throat spray (TT) in Xerostomia Due to Hyposecretion of Salivary Gland and Diabetes Mellitus, Type 2, sponsored by Certmedica International GmbH. Completed at 1 site in Italy. Open to participants aged 30 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-03-02.
Sponsored by Certmedica International GmbH · Not applicable, Interventional, and Prevention
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.
Exclusion Criteria:
The randomized part of the participants who started first with the artificial saliva spray taking it three times a day for a three days treatment, followed by a wash out phase of 3 days. After wash out phase they take for three days the marine water throat spray taking it three times a day for a three days treatment.
Device: artificial saliva spray (AS) · Other: maritime throat spray (TT)
The randomized part of the participants who started first with the marine water throat spray taking it three times a day for a three days treatment, followed by a wash out phase of 3 days. After wash out phase they take for three days the artificial saliva spray taking it three times a day for a three days treatment.
Device: artificial saliva spray (AS) · Other: maritime throat spray (TT)
cross over design
cross over design
xerostomia
xerostomia was measured according to a semi-quantal visual scale (or VAS; visual analogue scale) ranging from 0 to 6 with intervals of 1 point
Time frame: first day before treatment; change to third day after treatment (day 1+3; 7+9)
stimulated salivary flow
Subject was asked to chew a standard square of medical cotton for one minute rolling the cotton in the mouth in order to collect the saliva. The measure of the flow consisted in weighing the cotton before and after the chewing
Time frame: first day before treatment; change to third day after treatment (day 1+3; 7+9)
antioxidant capacity of saliva (SAT test)
The test utilizes the capacity of thiocyanate (SCN) to react with iron (Fe3+) causing the formation of FE((SCN)6)3-.
Time frame: first day before treatment; changes to third day after treatment (day 1+3; 7+9)
patients preference for treatment AS or TT
question in regard to the preference
Time frame: third day after finalization of the treatment period (day 3; 9)
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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Certmedica International GmbH