Long-term outcomes of osteotome sinus floor elevation with or without bone grafting: The 10-year results of a randomized controlled trial.

AIMS: To assess the long-term clinical and radiographic results of implants placed using osteotome sinus floor elevation (OSFE) with or without bone grafting. MATERIALS AND METHODS: Forty-five patients were randomly assigned into two groups: Group 1 (OSFE with deproteinized bovine bone mineral) and Group 2 (OSFE without grafting). The patients were recalled at 1, 3, 5 and 10 years after surgery. The implant survival, endo-sinus bone gain (ESBG), marginal bone loss (MBL), peri-implant bone height (PBH, distance from the most coronal level to the most apical level of bone-to-implant contact), prosthesis survival and hardware complications, and peri-implant soft tissue conditions were assessed. RESULTS: Forty patients attended the 10-year examination. Mean residual bone height was 4.58 ± 1.28 mm. The 10-year cumulative survival rate was 90.7% for Group 1 and 95.0% for Group 2. The PBH was 5.89 ± 1.24 mm for Group 1 and 5.74 ± 1.43 mm for Group 2 at 10 years. The ESBG of both groups remained stable after 3 years. Two-thirds of the implants were free of hardware complications. No significant differences in MBL and peri-implant tissue parameters were found. CONCLUSION: OSFE with or without grafting both yielded predictable clinical outcomes with similar PBH (ClinicalTrials.gov. NCT01619956).