Bioceramics for Guided Bone Regeneration: A Multicenter Randomized Controlled Trial.

Abstract

Objectives: To compare the clinical effectiveness of a novel bioceramic (BC) with a control xenograft (BO) for guided bone regeneration (GBR) performed simultaneously with implant placement.

Materials and methods: This clinical study enrolled patients with insufficient bone volume who required GBR during implant placement to increase bone width using either BC or BO. Outcome measures included a dimensional reduction in buccal bone thickness measured by cone beam computed tomography performed immediately post-surgery and at 6 months postoperatively (ΔHBBT), soft tissue healing at 14 days, 1 month, and 6 months postoperatively, and complications rates. The primary outcome was the change in buccal bone thickness around the implant.

Results: Of the total 152 patients included, 76 from each group received BC and BO treatments. The ΔHBBT in BC and BO groups were -0.276 mm (-0.432, -0.121) and -0.614 mm (-0.769, -0.459) mm, respectively, rejecting the null hypothesis. No significant difference in soft tissue healing was observed between the two groups, with no inflammatory changes in 96.05% and 90.79% of the BC and BO groups, respectively, at 2 weeks postoperatively. However, the BC group exhibited a lower overall complication rate (3.95%), including mild inflammation, poor soft tissue healing, and bone graft extrusion in 3 out of 76 patients.

Conclusions: Both BC and BO demonstrated favorable outcomes in bone regeneration and soft tissue healing when used for simultaneous implant placement and bone augmentation.