Radiation-induced mucositis K12.3 K11.7
Conditions
Interventions
Group 1: Patients of the Department of Radiation Medicine will be recruited for the study if they receive primary radiochemotherapy (60-70Gy tumor dose and 2-3x 100mg/2 cisplatin) due to a locally adv
in particular, defined mucositis assessments, dental status (caries status, periodontal status), nutritional habits questionnaires, xerostomia assessment, quality of life, as well as the collection of
Sponsors
Stiftungsprofessur für Kariesforschung Klinik für Zahnerhaltungskunde und Parodontologie Department f. Zahn-, Mund- u. KieferheilkundeUniversitätsklinikum Freiburg
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients: Age of majority, informed consent, sufficient knowledge of German, tumor in the oral cavity, oropharynx, hypopharynx or larynx, planned radiation in the head, neck area according to a standardized protocol (cisplatin-based radiochemotherapy with a radiation dose of 60-70 Gy in a fractionation of 5 x 2 Gy / week) Controls: Age of majority, informed consent, sufficient knowledge of German
Exclusion criteria
Exclusion criteria: Patients: Presence of xerostomia or hyposalivation prior to radiation, prior to tumor therapy drug intake with influence on salivation, prior to tumor therapy antibiotic or antifungal drug intake (currently up to three months prior to the start of the study), failed tooth restoration at the beginning of radiation (cavitated carious lesions, insufficient fillings down to the dentin, deep and inflamed periodontal pockets), allergies to the dental materials used and the local anaesthetic, complete or partial removal of the large salivary glands as part of surgical tumour therapy, pregnancy or breastfeeding. Controls: Presence of xerostomia or hyposalivation, medication with influence on salivation, intake of an antibiotic or antifungal (currently up to three months before the start of the study), dentition in need of restoration (cavitated carious lesions, insufficient fillings down to the dentin, deep and inflamed periodontal pockets), allergies to the dental materials used and the local anaesthetic, complete or partial removal of the large salivary glands, pregnancy or nursing period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Association between clinical occurrence of mucositis and changes in quantitative and qualitative cell culture parameters and changes in microbiological, protein-based and basic saliva parameters | — |
Secondary
| Measure | Time frame |
|---|---|
| Change of basic saliva parameters (flow rate, pH, buffer cap.) by tumor-therapeutic radiation Modification of microbial and protein-based saliva parameters by tumor-therapeutic radiation Differences in microbial, protein-based and basic saliva parameters and in quantitative and qualitative cell culture parameters between patients and healthy control subjects | — |
Countries
Germany
Contacts
Public ContactBenedikt Luka
Stiftungsprofessur für Kariesforschung Klinik für Zahnerhaltungskunde und Parodontologie Department f. Zahn-, Mund- u. KieferheilkundeUniversitätsklinikum Freiburg
Outcome results
None listed