Effects of Mucoprotective Product on Xerostomia

Phase 4

Completed

• Conditions: Xerostomia

• Registration Number: NCT01316393
• Lead Sponsor: Camurus AB

Brief Summary

In the present study with a randomized, cross-over, blind, placebo controlled design, the effects of a salivary substitute product and a new mucoprotective product with similar mechanisms of action but with different composition and characteristics will be evaluated in cancer patients suffering from xerostomia.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-03-15
• Study First Submitted QC: 2011-03-15
• Study First Posted: 2011-03-16
• Primary Completion: 2011-05
• Study Completion: 2011-06
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-08
• Last Update Posted: 2011-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. The patient must be at least 18 years of age.
2. The patient must have clinical symptoms of xerostomia (dry mouth) due to treatment of head and neck cancer
3. The patient must understand and consent in writing to the procedure.

Exclusion Criteria

1. Do not meet the criterion for "dry mouth" regarding saliva secretion threshold values.
2. Known allergy to ingredients in the products to be used in the trial and/or allergy to soy, peanuts, citrus fruit,Yerba Santa or methyl parabene
3. Patients who are unable or unwilling to cooperate with study procedures.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
OHIP questionaire health impact profile	7 days	Effect on oral health quality will be assessed after each treatment period

Trial Locations

Locations (1)

Department of Prosthetic Dentistry, Malmö University; 🇸🇪 Malmö, Sweden