Randomized Clinical Trial of Maxillary Sinus Grafting using Deproteinized Porcine and Bovine Bone Mineral.
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.


OBJECTIVE
The present randomized controlled clinical trial aimed to compare histological bone quality and radiographic volume stability in maxillary sinuses grafted with DPBM and DBBM.


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.
Department of Periodontology, Research Institute for periodontal regeneration, Yonsei University College of Dentistry, Seoul, Republic of Korea.
Jung-Seok
JS
Lee
Department of Periodontology, Research Institute for periodontal regeneration, Yonsei University College of Dentistry, Seoul, Republic of Korea.
Hyun-Ki
HK
Shin
Department of Periodontology, School of Dentistry and Institute of Oral Bioscience, Chonbuk National University, Jeonju, Republic of Korea.
Jeong-Ho
JH
Yun
Department of Periodontology, Research Institute for periodontal regeneration, Yonsei University College of Dentistry, Seoul, Republic of Korea.
Kyoo-Sung
KS
Cho
D000328:Adult; D001706:Biopsy; D018786:Bone Substitutes; D016025:Bone Transplantation / Q000379:methods*; D002113:Calcification, Physiologic; D003758:Dental Implantation, Endosseous / Q000379:methods*; D005260:Female; D006801:Humans; D008297:Male; D008443:Maxillary Sinus / Q000000981:diagnostic imaging / Q000473:pathology* / Q000601:surgery*; D008875:Middle Aged; D016037:Single-Blind Method; D059546:Sinus Floor Augmentation / Q000379:methods*; D014057:Tomography, X-Ray Computed; D014183:Transplantation, Heterologous / Q000379:methods*
D018786:Bone Substitutes
Bio-Oss; alveolar bone grafting; randomized controlled trial; sinus floor augmentation