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The Artificial Saliva Spray Reduces Xerostomia in Diabetes Type II

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ClinicalTrials.gov Identifier: NCT03452085
Recruitment Status : Completed
First Posted : March 2, 2018
Last Update Posted : March 2, 2018
Sponsor:
Information provided by (Responsible Party):
Certmedica International GmbH

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) Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
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.)

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 : September 23, 2017
Actual Primary Completion Date : November 4, 2017
Actual Study Completion Date : January 16, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dry Mouth

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




Primary Outcome Measures :
  1. xerostomia [ Time Frame: 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 :
  1. stimulated salivary flow [ Time Frame: 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

  2. antioxidant capacity of saliva (SAT test) [ Time Frame: 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-.

  3. patients preference for treatment AS or TT [ Time Frame: third day after finalization of the treatment period (day 3; 9) ]
    question in regard to the preference



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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03452085


Locations
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Italy
Irwin Labs, University of Chieti
Chieti, PE, Italy, 65010
Sponsors and Collaborators
Certmedica International GmbH

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Responsible Party: Certmedica International GmbH
ClinicalTrials.gov Identifier: NCT03452085     History of Changes
Other Study ID Numbers: IAPSSAPP
First Posted: March 2, 2018    Key Record Dates
Last Update Posted: March 2, 2018
Last Verified: January 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Certmedica International GmbH:
xerostomia
diabetes type II
salivary flow
antioxidant capacity of saliva
aldiamed

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Xerostomia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases