The Artificial Saliva Spray Reduces Xerostomia in Diabetes Type II

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03452085
• Other study ID #: IAPSSAPP
• Status: Completed
• Phase: N/A
• First received: February 3, 2018
• Last updated: February 28, 2018
• Start date: September 23, 2017
• Est. completion date: January 16, 2018

Study information

• Verified date: January 2018
• Source: Certmedica International GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: January 16, 2018
• Est. primary completion date: November 4, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• artificial saliva spray (AS)
cross over design

Other:
• maritime throat spray (TT)
cross over design

Locations

Country	Name	City	State
Italy	Irwin Labs, University of Chieti	Chieti	PE

Sponsors (1)

Lead Sponsor	Collaborator
Certmedica International GmbH

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	patients preference for treatment AS or TT	question in regard to the preference	third day after finalization of the treatment period (day 3; 9)