Sinus lift with guided bone regeneration or anorganic bovine bone: 1-year post-loading results of a pilot randomised clinical trial.

PURPOSE: To compare the efficacy of two different techniques for maintaining the space beneath a maxillary lining lifted using a lateral window approach: rigid synthetic resorbable barriers versus granular anorganic bovine bone. MATERIALS AND METHODS: Ten partially edentulous patients having bilaterally 1 to 5 mm of residual bone height and at least 5 mm bone width below the maxillary sinuses, were randomised in a split-mouth study design, to receive a rigid Inion GTR Biodegradable Membrane System barrier without any graft on one side and 100% loosely packed granular Bio-Oss on the contralateral side following a lateral window, two-stage, sinus lift procedure. After 6 months, two or three implants were inserted at each side and submerged for 4 months. Implants were loaded with provisional acrylic prostheses and replaced, after 4 months, by definitive metal-ceramic prostheses cemented with provisional cement. Outcome measures were implant and prosthetic failures, any complication and peri-implant marginal bone level changes assessed by a blinded outcome assessor. All patients were followed up to 1 year after loading. RESULTS: One patient dropped out after implant placement. One distal implant failed at the Inion side just before delivery of the definitive prosthesis, which was cut and maintained as a single crown. Four complications occurred in three patients at Inion sites (two sinus lining perforations, one fracture of the ceramic cusp of the definitive prosthesis, one iatrogenic peri-implantitis) versus two complications at Bio-Oss sites (one sinus lining perforation and one iatrogenic peri-implantitis). There were no differences for failures or complications between groups; however, in one of the patients where a perforation occurred at the Inion site, at implant placement, the sinus was filled two-thirds with soft tissue and the site was retreated with Bio-Oss. There were no statistically significant differences in bone loss between groups. One year after loading, Inion sides lost an average of 1.5 mm of periimplant bone and Bio-Oss sides about 1.7 mm. CONCLUSIONS: A bone graft may not be needed to augment atrophic maxillary sinuses since it is sufficient to keep space with a rigid barrier; however, it may be simpler to fill sinuses with a bone substitute than positioning a rigid barrier to maintain space.