Randomized Clinical Trial of Maxillary Sinus Grafting using Deproteinized Porcine and Bovine Bone Mineral
Abstract
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…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 16 participants or records.
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