Xerostomia
Conditions
Keywords
xerostomia, saliva, mucoprotection, oral health
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.
Interventions
OTHERXER2020
mucoprotective product
Sponsors
Liselott Lindh, Principal Investigator, Prosthetic Dentistry, Malmö University, Malmö, Sweden
Camurus AB
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| OHIP questionaire health impact profile | 7 days | Effect on oral health quality will be assessed after each treatment period |
Countries
Sweden
Outcome results
None listed