Comparison of Bone Augmentation Techniques in the Mandibular Posterior Region: A Randomized Clinical Trial Protocol

This randomized, double-blind, parallel-group clinical trial will compare the effectiveness of three bone-augmentation techniques applied to the posterior mandible using the cortical shell approach. Seventy-eight participants will be randomly allocated into three groups (autogenous, xenogeneic, or allogeneic cortical shells), each combined with a 1:1 mixture of autogenous bone chips and biomaterial. The study was approved by the CEISH-ITSUP Ethics Committee (Approval No. 1715824376) and is registered at ClinicalTrials.gov (Identifier: NCT06661447). Recruitment has not yet begun. The primary outcome will be horizontal bone gain (mm) evaluated by cone-beam computed tomography (CBCT) at 3, 6, and 12 months. Volumetric and morphometric analyses will be performed through a standardized digital workflow integrating intraoral scanning, CBCT segmentation, and surface registration. Secondary outcomes will include bone density, surgical duration, and postoperative inflammation. Based on previous CBCT-based randomized clinical trials, a total of 78 participants (26 per group) will provide 80-90% power to detect a 1.0 mm difference in horizontal bone gain among groups. This study aims to generate controlled, quantitative evidence on the volumetric and clinical performance of different cortical graft materials for posterior mandibular reconstruction.