ORIGINAL ARTICLE Histological and radiological evaluation of sintered and non-sintered deproteinized bovine bone substitute materials in sinus augmentation procedures. A prospective, randomized-controlled, clinical multicenter study Tim Fienitz 1 & Ofer Moses 2 & Christoph Klemm 1 & Arndt Happe 3 & Daniel Ferrari 4 & Matthias Kreppel 1 & Zeev Ormianer 5 & Moti Gal 6 & Daniel Rothamel 1 Received: 9 July 2015 /Accepted: 17 April 2016 # Springer-Verlag Berlin Heidelberg 2016 Abstract Objectives The objective of this study is to histologically and radiologically compare a sintered and a non-sintered bovine bone substitute material in sinus augmentation procedures. Materials and methods Thirty-three patients were included in the clinically controlled randomized multicentre study resulting in a total of 44 treated sinuses. After lateral approach, sinuses were filled with either a sintered (SBM, Alpha Bio’ s Graft ® ) or a non-sintered (NSBM, Bio Oss ® ) deproteinized bovine bone substitute material. The augmentation sites were radiologically assessed before and immediately after the aug- mentation procedure as well as prior to implant placement. Bone trephine biopsies for histological analysis were harvest- ed 6 months after augmentation whilst preparing the osteotomies for implant placement. Results Healing was uneventful in all patients. After 6 months, radiological evaluation of 43 sinuses revealed a residual aug- mentation height of 94.65 % (±2.74) for SBM and 95.76 % (±2.15) for NSBM. One patient left the study for personal reasons. Histological analysis revealed a percentage of new bone of 29.71 % (±13.67) for SBM and 30.57 % (±16.07) for NSBM. Residual bone substitute material averaged at 40.68 % (±16.32) for SBM compared to 43.43 % (±19.07) for NSBM. All differences between the groups were not sta- tistically significant (p > 0.05, Student’ s t test). Conclusion Both xenogeneic bone substitute materials showed comparable results regarding new bone formation and radiological height changes in external sinus grafting procedures. Clinical relevance Both bone substitute materials allow for a predictable new bone formation following sinus augmentation procedures. Keywords Xenograft . Augmentation . Implantology . Sinuslift . Bone substitute . Sintering Introduction Sinus augmentation procedures can be performed either with or without the use of autogenous bone, xenogeneic, allogeneic or alloplastic bone substitute materials [1, 21, 22]. Autogenous bone is harvested from the patient himself re- quiring a second operation site to gain enough volume for augmentation. Common harvesting sites are the retromolar region [14], the chin [18] or the iliac crest [11]. These are often accompanied by increased morbidity and patient discomfort [5, 10, 15]. Bone substitute materials may be used to avoid these dis- advantages and do not have any volume limitations. Predictable results in sinus augmentation procedures have been shown for allogeneic materials [6], xenogeneic materials [16] as well as alloplastic materials [4]. * Daniel Rothamel daniel.rothamel@uk-koeln.de 1 Department of Craniomaxillofacial and Plastic Surgery, University Hospital of Cologne, Kerpener Str. 62, 50931 Cologne, Germany 2 Department of Periodontology and Dental Implantology, Tel-Aviv University, Tel Aviv, Israel 3 Private Practice, Muenster, Germany 4 Private Practice, Duesseldorf, Germany 5 Department of Oral Rehabilitation, School of Dental Medicine, Tel Aviv University, Tel Aviv, Israel 6 Faculty of Life Sciences, Bar Ilan University Ramat Gan, Ramat Gan, Israel Clin Oral Invest DOI 10.1007/s00784-016-1829-9