IMMEDIATE NON-OCCLUSAL VERSUS EARLY LOADING OF DENTAL IMPLANTS IN PARTIALLY EDENTULOUS PATIENTS-—15-YEAR FOLLOW-UP OF A MULTICENTRE RANDOMISED CONTROLLED TRIAL

PURPOSE. To compare peri-implant bone and soft-tissue levels at immediately non-oc-clusally loaded versus non-submerged early-loaded implants in partially edentulous patients 15 years after loading. MATERIALS AND METHODS. Fifty-two patients from five Italian private practices were randomised, 25 to immediate loading and 27 to early loading. To be immediately loaded, single full Osseotite implants had to be inserted with a torque of at least 30 Ncm, and splinted implants with a torque of at least 20 Ncm. Immediately loaded implants were provided with non-occluding temporary restorations within 48 hours, which were brought into full occlusion after 2 months. In the early loading group, implants were loaded after 2 months. Definitive restorations were provided 8 months after implant placement in both groups. Outcome measures were prosthesis failures, implant failures and complica-tions, recorded by non-blinded assessors, and peri-implant bone and soft-tissue levels, as evaluated by blinded assessors. RESULTS. Fifty implants were loaded immediately and 54 early. Twelve patients with 24 implants dropped out from the immediate group versus 11 patients with 22 implants from the early loaded group, but all remaining patients were followed up for at least 15 years after loading. One single implant with its provisional crowns and one definitive prothesis failed in the immediate loading group. Seven patients with immediately loaded and two with early loaded implants reported complications. There were no statistically significant differences between groups in terms of implant failures (Fisher’s exact test P = 0.481; diff. =-0.04, 95% CI:-0.16 to 0.08), prosthesis failures (Fisher’s exact test P = 0.226; diff. =-0.08, 95% CI:-0.21 to 0.06), or complications (Fisher’s exact test P = 0.066; diff. =-0.22, 95% CI:-0.41 to 0.01). There were also no statistically significant differences in peri-implant bone (diff. = 0.28 mm, 95%CI:-0.35 to 0.91; P = 0.368) or soft-tissue level changes (diff. = 0.34 mm, 95%CI:-0.32 to 1.00; P = 0.292) between the two groups. Specifically, after 15 years immediately loaded patients had lost an average of 1.75 mm, and early loaded patients an average of 1.44 mm of peri-implant marginal bone. CONCLUSIONS. The long-term prognosis of prostheses supported by both immediately and early-loaded implants seems favourable.