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Completed

NCT Number: NCT01316393

Effects of Mucoprotective Product on Xerostomia

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.

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Key information

Conditions

Xerostomia Mouth Diseases Salivary Gland Diseases Stomatognathic Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Prosthetic Dentistry, Malmö University

Malmö, SE-21421, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Do not meet the criterion for "dry mouth" regarding saliva secretion threshold values.
  • 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
  • Patients who are unable or unwilling to cooperate with study procedures.

Treatment and study plan

XER2020

Other

mucoprotective product

Primary outcomes

  1. OHIP questionaire health impact profile

    Time frame: 7 days

    Effect on oral health quality will be assessed after each treatment period

Sponsors and collaborators

Lead sponsor

Camurus AB

Industry

Collaborators

  • Liselott Lindh, Principal Investigator, Prosthetic Dentistry, Malmö University, Malmö, Sweden

Registry information

Official study title

Clinical Evaluation of a Salivary Substitute and a Mucoprotective Product on Xerostomia in Head-and-neck Cancer Patients

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Mar 16, 2011
Registry last updated
Nov 9, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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