Osteotome sinus floor elevation with and without grafting material in the severely atrophic maxilla. A 1-year prospective randomized controlled study

Objectives (1) To measure and compare endo‐sinus bone levels around implants randomly placed with an osteotome sinus floor elevation (OSFE) procedure in grafted (control) and non‐grafted (test) sinuses, (2) to evaluate the OSFE efficacy with short, tapered, and chemically modified hydrophilic surfaced implants in extremely atrophic maxillae, (3) to show that fused corticals may constitute a complication risk. Material and methods The TE® SLActive 8 mm‐long implants (Straumann AG) were placed using an OSFE procedure in 4 mm or less of bone height. Healing time before prosthetic rehabilitation was 10 weeks. One year after implant placement, bone levels were measured on standardized periapical radiographs. Results Thirty‐seven (17 tests, 20 controls) implants were placed in 12 patients with a mean maxillary residual bone height (RBH) of 2.4 ± 0.9 mm. Before loading, two control implants failed (RBH 1.4 and 1.2 mm); two others rotated at loading (one test, RBH 0.9 mm; one control, RBH 1.5 mm) but were uneventfully loaded after three additional months of healing. These adverse events and complications occurred when implants were placed in merged corticals. Endo‐sinus bone gain was 3.9 ± 1.0 and 5.0 ± 1.3 mm for the test and control groups (P = 0.003). The 1‐year success rate was 100% and 90%, respectively (P = 0.49). Conclusion Although more bone is gained when grafting material is used, this may not be required to promote endo‐sinus bone gain. The OSFE procedure with or without grafting material could be efficient when the RBH is ≤4 mm. However, when both corticals merged, the risk of complication could increase.