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The use of an injectable bone substitute based on biphasic calcium phosphate in a two-stage maxillary sinus floor augmentation: radiological and histological evaluation

Introduction: Maxillary sinus floor augmentation (MSFA) is indicated prior to dental implant placement when the height of the residual alveolar crest is insufficient. When choosing bone graft material, autologous bone is the gold standard. However, because there are limitations while using it, regarding availability and morbidity at the donor site, different alternatives have been developed. One of these is biphasic calcium phosphate (BCP), consisting of 60% hydroxyapatite and 40% β- tricalcium phosphate, known for its osteoconductive and osteoinductive properties. The injectable form of this material allows easy handling and application. Currently, there are no clinical studies on the use of an injectable biphasic calcium phosphate (I-BCP) in two-stage MSFA. Hypotheses: 1. The use of I- BCP in two-stage MSFA leads to bone regeneration. 2. I-BCP undergoes nearly complete degradation. Aims: 1. To examine the bone regenerative potential of an I-BCP by assessing histological results of bone biopsy harvested from maxillary sinus. 2. To analyze radiological changes of the augmented area. 3. To assess degradation of I-BCP 6 months after augmentation. 4. To register wound healing complications. Participants and methods: Twenty healthy patients, who require two-stage MSFA prior to implant placement and with a residual bone height of 5mm or less, will be selected. Unilateral MSFA according to Tatum will be performed with I-BCP. Implant placement will be performed after 6 months of healing. Simultaneously with implant placement, bone biopsy for histologic analysis will be harvested using trephine burr and fixed in 4% formaldehyde. The sections will be examined under a light microscope. Cone beam CT will be done immediately after the first stage of MSFA and 6 months after, prior to the re-entry procedure. During the study detailed photographic documentation of all clinical procedures and healing process will be done. Data will be analyzed using the Statistical Package for the Social Sciences (SPSS). Research plan: This prospective, single-arm study will be performed in the period between October 2018 and December 2019. Patients will be recruited in a Community Health Center in Osijek. To enter the study, patients need to provide written consent. All surgeries will be performed by one experienced oral surgeon. Expected scientific contribution: This study will provide a valuable clinical, histological, and radiological results that can simplify bone augmentation procedures.

maxillary sinus floor augmentation, CBCT, histology, biphasic calcium phosphate

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