Clinical evaluation of demineralized bone allograft in a hyaluronic acid carrier for sinus lift augmentation in humans: a computed tomography and histomorphometric study

Abstract

Objectives: Natural and synthetic graft materials are used routinely in sinus floor augmentations to help support implants in atrophic maxillary ridges. This clinical study was based on the hypothesis that the clinical effectiveness of demineralized freeze-dried bone allograft/demineralized bone matrix (DFDBA/DBM) in sinus lifts varies when used in combination bone graft substitute materials. To test this hypothesis, DFDBA was used together with one of three materials: in saline plus anorganic bone (DFDBA: Bio-Oss; in hyaluronic acid (DFDBA: HY, 32 : 68, w/w; DBX alone; DBX plus Bio-Oss; and DBX plus tricalcium phosphate granules (beta-TCP).

Material and methods: Thirty-two sinus lift procedures, eight per group, were performed on 26 patients. Before surgery and at 8 months post-surgery when implants were placed, ridge heights were visualized by computed tomography (CT) and measured by morphometric analysis. Cores of bone were removed by trephine at the sites of implant placement; these biopsies from the graft sites were used for histomorphometric analysis.

Results: All 32 sinus lift elevations were successful when measured by CT, increasing from an average 2.84+/-0.2 mm before treatment to 15.2+/-0.6 mm after treatment. The percent of each biopsy that was occupied by new bone and incorporated bone graft materials varied with each treatment: DFDBA+Bio-Oss, DBX+Bio-Oss, or DBX alone was higher than that for DBX+beta-TCP by approximately 10%. When comparing only newly formed bone, DBX+beta-TCP treatment resulted in 50% less bone than the other three preparations. All grafted sites received implants as per the treatment plan for each patient.

Conclusions: This study confirmed the hypothesis that new bone formation is dependent on the DFDBA formulation used and demonstrated that DBX, alone or in combination with other materials, can be used successfully for sinus floor elevation.