The Artificial Saliva Spray Reduces Xerostomia in Diabetes Type II

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2; Xerostomia Due to Hyposecretion of Salivary Gland
• Intervention / Treatment: Device: artificial saliva spray (AS); Other: maritime throat spray (TT)

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 Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • PE
    • Chieti, PE, Italy, 65010
      • Irwin Labs, University of Chieti

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 28 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	first day before treatment; change to third day after treatment (day 1+3; 7+9)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	first day before treatment; change to third day after treatment (day 1+3; 7+9)
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-.	first day before treatment; changes to third day after treatment (day 1+3; 7+9)
patients preference for treatment AS or TT	question in regard to the preference	third day after finalization of the treatment period (day 3; 9)

Collaborators and Investigators

• Sponsor: Certmedica International GmbH

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2017
• Primary Completion (Actual): November 4, 2017
• Study Completion (Actual): January 16, 2018

Study Registration Dates

• First Submitted: February 3, 2018
• First Submitted That Met QC Criteria: February 28, 2018
• First Posted (Actual): March 2, 2018

Study Record Updates

• Last Update Posted (Actual): March 2, 2018
• Last Update Submitted That Met QC Criteria: February 28, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: xerostomia; diabetes type II; salivary flow; antioxidant capacity of saliva; aldiamed
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Stomatognathic Diseases; Mouth Diseases; Salivary Gland Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Xerostomia
• Other Study ID Numbers: IAPSSAPP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No