Randomized double-blind crossover study to compare the efficacy of GUM HYDRAL Mouth Wash and Gel versus Biotene Mouth wash and Gel on medication-induced xerostomia (MPG23b)
- Conditions
- Medication-induced dry mouthT88.7Unspecified adverse effect of drug or medicament
- Registration Number
- DRKS00009685
- Lead Sponsor
- Abteilung für Zahnerhaltung und Parodontologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 40
Minimum age: at least 18 years of age
Written informed consent
Daily intake of at least one drug with medication-induced xerostomia as declared side effect in the product insert (the patient will be asked at the beginning of the trial about taken drug names and application rates) and as it is stated in the attached Hydral Medications List and in (Screebny et al.)
Subjective xerostomia: Minimum level of xerostomia on a VAS scale: 4 of 10
Minimum number of teeth: 4
Any allergic or undesired condition stated in the case history on one of the study product ingredients
Pregnancy or planned pregnancy during the study
Current or anamnestic radiation therapy or chemotherapy
Current or anamnestic parotid malignancy
Current or anamnestic head/neck malignancy
Current or anamnestic surgery in the head/neck region
Sjögren’s syndrome
Other medical reasons for xerostomia without drug intake
Current daily intake of symptom alleviating products against xerostomia (other than high frequent water intake)
Smoking of more than 10 cigarettes/day
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method