Early loading of ITI implants supporting a maxillary full-arch prosthesis: 1-year data of a prospective, randomized study.
PURPOSE: This prospective, randomized study investigated the safety, feasibility, and reliability of the early loading of implants in edentulous maxillae. MATERIALS AND METHODS: Twenty-four patients with completely edentulous maxillae were randomized into a test group (n = 16) and a control group (n = 8). All patients received 5 or 6 solid screw-type titanium implants. These were loaded with full-arch prostheses after 9 to 18 days in the test group and after 2.5 to 5.1 months in the control group. Periapical radiographs were taken and routine clinical assessments were made at loading, after 6 months, and after 12 months. RESULTS: The implant survival rate 1 year after loading was 100%. Modified Plaque index scores and Sulcus Bleeding index scores were better in the test group than in the control group (P < or = .05). There was a significant difference in peri-implant bone height between the 2 groups (P < .001) and this difference converged with time (P < .001). DISCUSSION: This clinical, prospective, randomized, controlled study fulfilled the criteria for a comparable study. Owing to the small patient sample, the conclusions drawn were based on feasibility analyses of the results. Standard materials and methods were used. Only patients with maxillary bone of sufficient height and width were selected. The use of a single operator in each discipline--maxillofacial surgery, prosthodontics, and dental technology--may have improved the chances of achieving consistent standards and opinions. CONCLUSION: These results indicate that early loading in selected patients was as safe and reliable as delayed loading in this small patient population and may offer a satisfactory alternative to the standard protocol.