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NCT Number: NCT03452085

The Artificial Saliva Spray Reduces Xerostomia in Diabetes Type II

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.

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Key information

Conditions

Xerostomia Due to Hyposecretion of Salivary Gland Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Mouth Diseases Nutritional and Metabolic Diseases Salivary Gland Diseases Stomatognathic Diseases Xerostomia

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Irwin Labs, University of Chieti

Chieti, PE, 65010, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

artificial saliva spray (AS)

Device

cross over design

maritime throat spray (TT)

Other

cross over design

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Certmedica International GmbH

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Mar 2, 2018
Registry last updated
Mar 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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