A randomized, 12-month controlled trial to evaluate non-inferiority of early compared to conventional loading of modSLA implants in single tooth gaps

BACKGROUND: The aim of the study was to evaluate whether early loading of implants with a chemically modified sandblasted, large-grit, acid-etched (SLA) (SLActive®) surface was non-inferior to conventional loading in terms of change in crestal bone level. METHODS: This was a randomized, controlled, multicenter study. Patients requiring single-tooth rehabilitation in the posterior maxilla or mandible received implants and were randomized to receive a provisional restoration in occlusal load after 25 ± 3 days (early loading) or after 13 ± 1 weeks (conventional loading). The primary endpoint was change in crestal bone level between implant placement (baseline) and 6 months. Secondary endpoints included change in crestal bone level between baseline and 12 months, implant survival and success rates, and patient satisfaction. RESULTS: Of the 84 patients enrolled, 78 received implants and were randomized onto the early loading (41 patients) and conventional loading (37 patients) groups. The mean change in crestal bone level between baseline and 6 months was 0.56 ± 0.58 and 0.51 ± 0.62 mm for early and conventional loading, respectively; at 12 months, the mean change was 0.76 ± 0.60 and 0.73 ± 0.77 mm, respectively. Implant survival and success at 12 months were 100 % for both groups. Patient satisfaction was similar between the groups, except that more patients in the early loading group were satisfied or highly satisfied with the time taken for fitting. CONCLUSION: The study demonstrated that early implant loading was non-inferior to conventional implant loading in terms of crestal bone level change in a Japanese patient population in short follow-up period and single tooth gaps in molar regions.