OBJECTIVES:To compare peri-implant bone and soft-tissue levels of immediately non-occlusally loaded vs. non-submerged early loaded implants in partially edentulous patients up to 14 months after placement. MATERIAL AND METHODS:Fifty-two patients were randomized in five Italian private practices: 25 in the immediately loaded group and 27 in the early loaded group. To be immediately loaded, single implants had to be inserted with a torque of > or = 30 N cm, and splinted implants with a torque of > or = 20 N cm. Immediately loaded implants were provided with non-occluding temporary restorations within 48 h. After 2 months, the provisional restorations were placed in full occlusion. Implants were early loaded after 2 months. Final restorations were provided 8 months after placement. Blinded assessors evaluated peri-implant bone and soft-tissue levels. RESULTS:Fifty-two implants were immediately loaded and 52 were early loaded. No drop-out occurred. One single immediately loaded implant failed 2 months after placement. Both groups gradually lost peri-implant bone in a highly statistically significant manner at 2, 8, and 14 months. After 14 months, patients of both groups lost an average of 1.1 mm of peri-implant bone. There were no statistically significant differences between the two loading strategies for peri-implant bone and soft-tissue level changes (P > 0.05). After 14 months, the position of the soft tissues did not change significantly from baseline (delivery of the final restorations 8 months after placement). CONCLUSIONS:There were no statistically or clinically significant differences between immediate and early loading of dental implants with regard to peri-implant bone and soft-tissue levels as evaluated in the present study.