CCXBB (Bio-Graft® Geistlich Pharma) is a bone substitute material in a natural block form. The dimensions of the Bio-Graft block are 10 mm in height, 10 mm in length and 5 mm in width. It consists of a natural cancellous bone structure of hydroxyapatite and endogenous collagen type I and III, equine origin and is a class III medical device according to the Medical Device Directive 93/42 EECs’ definition (rule 8 implantable, resorbable device) and 17 (animal origin) in annex lX CE certificate G7 11 04 39446 050 for Geistlich Bio-Graft® was issued in June 2011.

The manufacture of Geistlich Bio-Graft is according to a standardized, controlled process and good manufacturing practices (GMPs). Each batch is manufactured and documented according to standard operating procedures, and the entire process has been validated.

The study design and follow-up visits have been summarized in Fig. 1. The primary outcome of this study was to assess the performance of the CCXBB by measuring the final crestal ridge width after 6 months of healing and evaluating its appropriateness for implant placement and the occurrence of adverse effects during healing.

Furthermore, the histological outcomes of this xenogeneic bone replacement graft were evaluated by harvesting a core biopsy of the regenerated area immediately before implant placement (after 6 months of healing), as well as the implant survival of those implants placed in the regenerated bone.

The surgical placement of the CCXBB blocks and the clinical evaluation has been described in detail in a previous publication [21]. In brief, severe alveolar horizontal bone deficiencies were isolated after rising full-thickness mucoperiosteal flaps. Once the horizontal width of the alveolar crest was measured 2 mm below the crest with a bone calliper bone blocks were shaped, pre-drilled and pre-hydrated for 5 min with sterile physiological saline before placement and were fixed with titanium osteosynthesis screws allowing for a stable contact between the block graft and the underlying bone. The spaces between the bone block and the surrounding bone were filled with DBBM particles (Geistlich Bio-Oss®, Geistlich Pharma AG, Wolhusen, Switzerland) and covered with a native collagen membrane (CM) (Geistlich Bio-Gide®, Geistlich Pharma AG, Wolhusen, Switzerland) fixed to the underlying bone with titanium tacks (FRIOS Fixation-Set®, SYMBIOS, Mainz, Germany). The muco-periosteal flaps were then coronally advanced and sutured achieving a tension-free primary closure (Fig. 2).