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The Artificial Saliva Spray Reduces Xerostomia in Diabetes Type II

Primary Purpose

Xerostomia Due to Hyposecretion of Salivary Gland, Diabetes Mellitus, Type 2

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
artificial saliva spray (AS)
maritime throat spray (TT)
Sponsored by
Certmedica International GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Xerostomia Due to Hyposecretion of Salivary Gland focused on measuring xerostomia, diabetes type II, salivary flow, antioxidant capacity of saliva, aldiamed

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

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

Sites / Locations

  • Irwin Labs, University of Chieti

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

artificial saliva spray (AS)

maritime throat spray (TT)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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-.
patients preference for treatment AS or TT
question in regard to the preference

Full Information

First Posted
February 3, 2018
Last Updated
February 28, 2018
Sponsor
Certmedica International GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT03452085
Brief Title
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

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
September 23, 2017 (Actual)
Primary Completion Date
November 4, 2017 (Actual)
Study Completion Date
January 16, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Certmedica International GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Xerostomia Due to Hyposecretion of Salivary Gland, Diabetes Mellitus, Type 2
Keywords
xerostomia, diabetes type II, salivary flow, antioxidant capacity of saliva, aldiamed

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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.)
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
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
artificial saliva spray (AS)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
maritime throat spray (TT)
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
artificial saliva spray (AS)
Intervention Description
cross over design
Intervention Type
Other
Intervention Name(s)
maritime throat spray (TT)
Intervention Description
cross over design
Primary Outcome Measure Information:
Title
xerostomia
Description
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)
Secondary Outcome Measure Information:
Title
stimulated salivary flow
Description
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)
Title
antioxidant capacity of saliva (SAT test)
Description
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)
Title
patients preference for treatment AS or TT
Description
question in regard to the preference
Time Frame
third day after finalization of the treatment period (day 3; 9)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Irwin Labs, University of Chieti
City
Chieti
State/Province
PE
ZIP/Postal Code
65010
Country
Italy

12. IPD Sharing Statement

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The Artificial Saliva Spray Reduces Xerostomia in Diabetes Type II

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