Background: Deproteinized porcine bone mineral (DPBM) was recently developed and commercially available in maxillary sinus grafting, in which demineralized bovine bone mineral (DBBM) was widely used. Objectives: The present randomized controlled clinical trial aimed to compare histological bone quality and radiographic volume stability in maxillary sinuses grafted with DPBM and DBBM. Materials and Methods: Twenty sinuses in 16 participants were enrolled and randomly allocated to control and test groups using sequentially numbered, sealed envelopes; laterally approached sinus grafting with DBBM and DPBM, respectively. All participants were blinded to the group assignment during the entire experiment. After standardized osteotomy at the lateral wall of the maxillary sinus, the sinus membrane was elevated, and the control or test biomaterial was grafted. Computed tomography (CT) images were taken immediately after surgery, and another CT and trephine biopsy was taken for radiographic and histological analyses after 6 months. The histological bone quality was measured as a primary outcome, and changes in the height and volume of the graft were evaluated in the reconstructed CT images as secondary outcomes. Results: Fifteen sites (7 and 8 sites for control and test group) in 11 participants were finally included in the per protocol (PP) analysis, and 16 sites (7 and 9 sites, respectively) in 12 participants were included in the intention-to-treat (ITT) analysis; there were four drop-outs and one minor protocol violation. In both statistical analyses, the test groups showed comparable new bone formation and residual biomaterials in histology, and both groups exhibited minimal volume/height changes in radiographies. However, smaller sizes of residual biomaterials were observed in the histological samples from the test compared to control sites, despite the use of the same sizes of both biomaterials. Conclusions: The results suggested that DPBM might produce comparable bone formation and volumetric stability with DBBM in maxillary sinus grafting, however, further clinical study with longer-term periods and larger sample sizes should be needed for confirming this suggestion.
Bibliographical noteFunding Information:
This work was supported by the Medical Device Comparative Clinical Trial and Performance Evaluation Program funded by the Small and Medium Business Administration (SMBA, Korea).
© 2016 Wiley Periodicals, Inc.
All Science Journal Classification (ASJC) codes
- Oral Surgery