The Artificial Saliva Spray Reduces Xerostomia in Diabetes Type II

NCT03452085 | Completed

• 1 other identifier: IAPSSAPP
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

xerostomia; diabetes type II; salivary flow; antioxidant capacity of saliva; aldiamed

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• stimulated salivary flow

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

• antioxidant capacity of saliva (SAT test)

  first day before treatment; changes to third day after treatment (day 1+3; 7+9)

• patients preference for treatment AS or TT

  third day after finalization of the treatment period (day 3; 9)

Study Arms (2)

artificial saliva spray (AS)

ACTIVE COMPARATOR

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); Other: maritime throat spray (TT)

maritime throat spray (TT)

PLACEBO COMPARATOR

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); Other: maritime throat spray (TT)

Interventions

artificial saliva spray (AS) DEVICE

cross over design

artificial saliva spray (AS); maritime throat spray (TT)

maritime throat spray (TT) OTHER

cross over design

artificial saliva spray (AS); maritime throat spray (TT)

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• under treatment for xerostomia or with xerostomia score \< 2
• suffering from obesity (BMI \> 30 kg/m2),
• cancer of any type
• drug addiction and alcoholism

Sponsors & Collaborators

• Certmedica International GmbH: lead

Study Sites (1)

Irwin Labs, University of Chieti

Chieti, PE, 65010, Italy

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Xerostomia

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The two types of pump-spray had a different bottle design but the bottles were blank with no identification
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Patients were randomized to two groups, whereas one group starts treatment with AS and the other group starts treatment with TT (control). After a wash out phase of 3 days, the patients have to take the other product for also 3 days. (e. g. randomized patient takes AS for 3 days, after a wash out period of 3 days he takes TT also for three days.)

Study Record Dates

• First Submitted: February 3, 2018
• First Posted: March 2, 2018
• Study Start: September 23, 2017
• Primary Completion: November 4, 2017
• Study Completion: January 16, 2018
• Last Updated: March 2, 2018

Record last verified: 2018-01

Locations

IT (1)