Walter, Christian
Sagheb, Keyvan
Blatt, Sebastian
Klein, Marcus Oliver
Herrmann, Jan
Kleinheinz, Johannes
Al-Nawas, Bilal
Funding for this research was provided by:
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Article History
Received: 13 April 2023
Accepted: 29 August 2023
First Online: 19 September 2023
Declarations
:
: The clinical investigation plan, patient information sheet as well as patient consent form were submitted for review and approval to the responsible ethics committees. The local ethical committees from each participating state in Germany accepted the study protocol (Ethik-Kommission Landesärztekammer Rheinland-Pfalz (837.369.15 (10137)), Ethik-Kommission Münster (2016-096-b-S), Ärztekammer Nordrhein (2015473), and Sächsische Landesärztekammer (EK-BR-107/15-1)). This clinical study was performed in accordance with the ethical principles of the Declaration of Helsinki and its amendments, concerning medical research in humans and ISO 14155:2011, as far as applicable for post-market studies. Written informed consent was received from all patients prior to admission into the study, as dictated by the Declaration of Helsinki and the ISO 14155:2011.
: Not applicable.
: The authors declare that they have no competing interests.
: This study was supported by Institute Straumann AG, Basel, Switzerland. As an industry sponsored study initiated by the manufacturer (Straumann Group, Basel, Switzerland), this study was monitored by an independent Contract Research Organization to ensure data quality.