Association between severity of mucositis, changes in different saliva parameter and the cellular wound healing potency during and after a radiation therapy in case of cancer in the head neck area

• Conditions: Radiation-induced mucositis; K12.3; K11.7; Oral mucositis (ulcerative); Disturbances of salivary secretion

• Registration Number: DRKS00013183
• Lead Sponsor: Stiftungsprofessur für Kariesforschung Klinik für Zahnerhaltungskunde und Parodontologie Department f. Zahn-, Mund- u. KieferheilkundeUniversitätsklinikum Freiburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-26
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Enrolling by invitation
• Sex: All
• Target Recruitment: 50

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

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

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Change of basic saliva parameters (flow rate, pH, buffer cap.) by tumor-therapeutic radiation<br>Modification of microbial and protein-based saliva parameters by tumor-therapeutic radiation<br>Differences in microbial, protein-based and basic saliva parameters and in quantitative and qualitative cell culture parameters between patients and healthy control subjects