CompletedNot Applicable

The Artificial Saliva Spray Reduces Xerostomia in Diabetes Type II

Italy21 participantsStarted 2017-09-23

Plain-language 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.

Who can participate

Age range30 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

xerostomia

Timeframe: first day before treatment; change to third day after treatment (day 1+3; 7+9)

Trial details

NCT IDNCT03452085

SponsorCertmedica International GmbH

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-11-04

View on ClinicalTrials.gov More Xerostomia Due to Hyposecretion of Salivary Gland trials