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). [ABSTRACT FROM AUTHOR]