The Artificial Saliva Spray Reduces Xerostomia in Diabetes Type II

Certmedica

Status: Completed

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

Treatments: Other: maritime throat spray (TT); Device: artificial saliva spray (AS)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03452085

IAPSSAPP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 21 patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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21 participants in 2 patient groups, including a placebo group

artificial saliva spray (AS)

Active Comparator group

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.

Treatment:

Device: artificial saliva spray (AS)

Other: maritime throat spray (TT)

maritime throat spray (TT)

Placebo Comparator group

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.

Treatment:

Device: artificial saliva spray (AS)

Other: maritime throat spray (TT)