R68.2
Conditions
Interventions
Group 1: N=15 patients receive sunflower oil and should use it 3 times a day for one week to gurgle for 5-10 minutes. Afterwards, a washout Phase of one week follows. Then, patients shall rinse their
Sponsors
Uniklinik KölnAbteilung für Zahnerhaltung und Parodontologie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Minimum age of 18 years Daily use of at least one drug which has drug-induced xerostomia declared as a side effect in its package insert xerostomia with minimum level on VAS Skala of 4 to 10 minimum number of four teeth
Exclusion criteria
Exclusion criteria: allergies relating to the ingredients of the products used in the study (oil) existing or planned pregnancy during the study current or anamnestic radiation therapy or chemotherapy treatment with antibiotics prior to the study current or anamnestic parotid gland tumor current or anamnestic tumor in regions of the head or neck current or anamnestic operation of the head or the neck Sjögren syndrome other medical causes for xerostomia which are not drug-induced current daily use of products which palliate the symptoms of xerostomia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| VAS xerostomic burden investigated by a validated questionnaire at day 0, after use of the first product (day 7), after the washout Phase (day 14) and after use of the second product (day 21). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary enpoints investigated by a validated questionnaire at day 0, after use of the first product (day 7), after the washout Phase (day 14) and after use of the second product (day 21). Hyposalivation / xerostomia: - Dirix P Dry mouth- questionnaire - VAS Subjective duration of residence and duration of action in the mouth-questionnaire - VAS flavor-questionnaire - Stimulated / unstimulated amount of saliva- objective measurement of the salivary flow rates in ml/min - Satisfaction and reuse of product Shadad- questionnaire Periodontal Situation (dental examination by dentist): - 01 / prosthetic findings - plaque index - gingivitis index halitosis: - OralChroma (measurements of volatile Sulfur compounds in breath air diagnosed via a gas chromatograph) - Organoleptic measurement (diagnosed by the dentist who breathes in defined way (cm) from the mouth) - Subjective halitosis assessment-questionnaire - Tongue coating- dental examination microbiology - mutans streptococci (SRT-Quicktest) - lactobacilli (SRT-Quicktest) - Candida albicans (Chromagar-culture and Rating the candida growth) | — |
Countries
Germany
Contacts
Public ContactGreta Barbe
Uniklinik KölnAbteilung für Zahnerhaltung und Parodontologie
Outcome results
None listed