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.