The Artificial Saliva Spray Reduces Xerostomia in Diabetes Type II

Sponsor

Certmedica International GmbH (Industry)

Overall Status

Completed

CT.gov ID

NCT03452085

Collaborator

(none)

Enrollment

Location

Arms

3.8

Actual Duration (Months)

5.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Xerostomia Due to Hyposecretion of Salivary Gland Diabetes Mellitus, Type 2	Device: artificial saliva spray (AS) Other: maritime throat spray (TT)	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

21 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

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.)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.)

Masking:

None (Open Label)

Masking Description:

The two types of pump-spray had a different bottle design but the bottles were blank with no identification

Primary Purpose:

Prevention

Official Title:

Artificial Saliva in Diabetes Type II: a Randomized Registry Cross Over Study

Actual Study Start Date :

Sep 23, 2017

Actual Primary Completion Date :

Nov 4, 2017

Actual Study Completion Date :

Jan 16, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: artificial saliva spray (AS) 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) cross over design Other: maritime throat spray (TT) cross over design
Placebo Comparator: 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) cross over design Other: maritime throat spray (TT) cross over design

Arm

Intervention/Treatment

Active Comparator: artificial saliva spray (AS)

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)

cross over design

Other: maritime throat spray (TT)

cross over design

Placebo Comparator: 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)

cross over design

Other: maritime throat spray (TT)

cross over design

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.