1-stage versus 2-stage lateral sinus lift procedures: 1-year post-loading results of a multicentre randomised controlled trial.

PURPOSE: To compare the efficacy of 1-stage versus 2-stage lateral maxillary sinus lift procedures. MATERIALS AND METHODS: Sixty partially edentulous patients requiring 1 to 3 implants and having 1 to 3 mm of residual bone height and at least 5 mm bone width below the maxillary sinus, as measured on CT scans were selected. They were randomised according to a parallel group study design into two equal arms to receive either a 1-stage lateral window sinus lift with simultaneous implant placement or a 2-stage procedure with implant placement delayed by 4 months, using a bone substitute in three different centres. Implants were submerged for 4 months, loaded with reinforced provisional prostheses, which were replaced, after 4 months, by definitive prostheses. Outcome measures, assessed by masked assessors, were: augmentation procedure failures; prosthesis failures and implant failures; complications; and marginal peri-implant bone level changes. Patients were followed up to 1 year after loading. Only data of implants placed in 1 to 3 mm of bone height were reported. RESULTS: Two patients dropped out from the 1-stage group and none from the 2-stage group. No sinus lift procedure failed in the 1-stage group but one failed in the 2-stage group, the difference being not statistically significant (P = 1.00). Two prostheses failed or could not be placed in the planned time in the 1-stage group and one in the 2-stage group, the difference being not statistically significant (P = 0.51). Three implants failed in three patients of the 1-stage group, versus one implant in the 2-stage group, the difference being not statistically significant (P = 0.28). Two complications occurred in the 1-stage group and one in the 2-stage group, the difference being not statistically significant (P = 0.61). One year after loading, 1-stage treated patients lost an average of -1.01 mm (SD: 0.56) of peri-implant bone and 2-stage sites about -0.93 mm (SD: 0.40). There were no statistically significant differences in bone level change between groups 1 year after loading (-0.08 mm 95%CI: -0.33 to 0.18 P = 0.56). CONCLUSION: No statistically significant differences were observed between implants placed according to 1- or 2-stage sinus lift procedures. However this study may suggest that in patients having residual bone height between 1 to 3 mm below the maxillary sinus, there might be a slightly higher risk for implant failures when performing a 1-stage lateral sinus lift procedure.