The study database will be designed and created throughout the project year 1. Due to data safety reasons and to comply with the data privacy protection, the personal data of every patient will be pseudonymized. This ensures the strictly split between the personal data and patient-related dataset (trial data).The Remote Data Entry (RDE) system generates automatically a pseudonym for every new patient. The pseudonym will be a combination of six alphanumeric characters. All trial data of the patient will be linked with this pseudonym. Personal data of the patient will not be saved in the trial database at any time. Data required for the analysis will be acquired and transferred electronically to a central database at Dental Unit MeSVA department. This system allows the documentation of study data on electronic case report form (eCRF). Study data will be entered online direct by the sites. The access to the eCRF requires the authentication by the study participants. All access rights (read or enter data) will be defined depending on their function in the study (Principle, clinical investigator, CRA, etc.). At the end of the study the data will be exported from the database.The study data will be prepared for the statistical analysis. This data management process contains the plausibility, consistency, identification of missing data and range checks of the data. Information of missing data will be given to the respective study centre for possible completion or explanation of missing data.