Diabetes Mellitus, Type 2, Xerostomia Due to Hyposecretion of Salivary Gland
Conditions
Keywords
xerostomia, diabetes type II, salivary flow, antioxidant capacity of saliva, aldiamed
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.
Interventions
DEVICEartificial saliva spray (AS)
cross over design
OTHERmaritime throat spray (TT)
cross over design
Sponsors
Certmedica International GmbH
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Masking description
The two types of pump-spray had a different bottle design but the bottles were blank with no identification
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.)
Eligibility
Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| xerostomia | first day before treatment; change to third day after treatment (day 1+3; 7+9) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| stimulated salivary flow | first day before treatment; change to third day after treatment (day 1+3; 7+9) | 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 |
| antioxidant capacity of saliva (SAT test) | first day before treatment; changes to third day after treatment (day 1+3; 7+9) | The test utilizes the capacity of thiocyanate (SCN) to react with iron (Fe3+) causing the formation of FE((SCN)6)3-. |
| patients preference for treatment AS or TT | third day after finalization of the treatment period (day 3; 9) | question in regard to the preference |
Countries
Italy
Outcome results
None listed