Clinical trial NCT03452085: The Artificial Saliva Spray Reduces Xerostomia in Diabetes Type II
Official title: Artificial Saliva in Diabetes Type II: a Randomized Registry Cross Over Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Xerostomia Due to Hyposecretion of Salivary Gland
Diabetes Mellitus, Type 2
Keywords: xerostomia
diabetes type II
salivary flow
antioxidant capacity of saliva
aldiamed
Lead sponsor: Certmedica International GmbH
Sponsor class: INDUSTRY
First posted: 2018-03-02
Enrollment: 21
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Patients were randomized to two groups, whereas one group starts treatment with AS and the other group starts treatment with TT (control).

After a wash out phase of 3 days, the patients have to take the other product for also 3 days.

(e. g. randomized patient takes AS for 3 days, after a wash out period of 3 days he takes TT also for three days.)
Primary purpose: PREVENTION

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 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.

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 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.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* under treatment for xerostomia or with xerostomia score \< 2
* suffering from obesity (BMI \> 30 kg/m2),
* cancer of any type
* drug addiction and alcoholism

Primary outcomes:
measure: xerostomia
timeFrame: first day before treatment; change to third day after treatment (day 1+3; 7+9)
Secondary outcomes:
measure: stimulated salivary flow
timeFrame: first day before treatment; change to third day after treatment (day 1+3; 7+9)
measure: antioxidant capacity of saliva (SAT test)
timeFrame: first day before treatment; changes to third day after treatment (day 1+3; 7+9)
measure: patients preference for treatment AS or TT
timeFrame: third day after finalization of the treatment period (day 3; 9)
Other outcomes:
Locations:
city: Chieti
country: Italy
facility: Irwin Labs, University of Chieti
state: PE
Study officials:
References: