Monophasic ß‐TCP vs. biphasic HA/ß‐TCP in two‐stage sinus floor augmentation procedures – a prospective randomized clinical trial

• Published in: Clinical oral implants research 2017-10, Vol.28 (10), p.e175-e183
• Main Authors: Jelusic, Damir, Zirk, Matthias L., Fienitz, Tim, Plancak, Darije, Puhar, Ivan, Rothamel, Daniel
• Format: Article
• Language: English
• Subjects: Augmentation; Biocompatibility; Biocompatible Materials - administration & dosage; Biomaterials; Biomedical materials; biphasic; Bone implants; Bone matrix; Bone Regeneration; bone substitute; Calcium Phosphates - administration & dosage; Clinical trials; Computed tomography; Dentistry; Durapatite - administration & dosage; Female; Frequency analysis; Grafting; Homogeneity; Humans; hydroxyapatite; implantology; Male; Middle Aged; Osteoconduction; Patients; Placement; Prospective Studies; Resonance; Sinus; Sinus Floor Augmentation - methods; sinus lift; Sinuses; Stability analysis; Surgical implants; β‐tricalcium phosphate
• ISSN: 0905-7161; 1600-0501
• DOI: 10.1111/clr.12983

Objectives To compare a monophasic (100% ß‐TCP) and a biphasic (60% HA and 40% ß‐TCP) bone substitute material (BSM) regarding biocompatibility, osteoconductivity and implant stability using histological, radiological and resonance frequency analysis. Material and Methods Sixty‐seven sinus floor elevations were performed in 60 patients. One patient group (monophasic bone substitute [MBS], 30 patients, 32 sinuses) was augmented by the use of the monophasic material (Bioresorb®, Sybron Implant Solutions, Bremen, Germany), while the second group (biphasic bone substitute (BBS), 30 patients, 35 sinuses) received a biphasic material (Maxresorb®, Botiss Biomaterials, Berlin, Germany). Cone beam CT images were taken immediately after augmentation and prior to implant placement after 6 months. Trephines were harvested, while the implant bed was prepared. Resonance frequency analysis was performed immediately after implant placement and 6 months later. Descriptive analysis was performed on all augmented sinus (n = 67). For statistical comparison of the groups, one sinus of each bilaterally treated patient was randomly excluded, resulting in 30 sinuses grafted with MBS and 30 sinuses grafted with BBS (n = 60). Results Histomorphometrical analysis of all sinuses displayed comparable results for both groups regarding new bone matrix (MBS 36.16 ± 19.37%, BBS 38.42 ± 12.61%), residual BSM (MBS 30.26 ± 11.7%, BBS 32.66 ± 12.57%) and non‐mineralized tissue (MBS 34.29 ± 18.32%, BBS 28.92 ± 15.04) %) (P > 0.05, respectively). Radiological volume of BBS was significantly more stable (volume loss of 22.2% for MBS, 6.66% for BBS; P