Purpose: To compare peri-implant bone and soft-tissue levels of immediately non-occlusally loaded versus non-submerged early loaded implants in partially edentulous patients 5 years after implant placement. Materials and methods: Fifty-two patients were randomised 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 > 30 Ncm, and splinted implants with a torque of > 20 Ncm. Immediately loaded implants were provided with non-occluding temporary restorations within 48 hours. After 2 months, the provisional restorations were put in full occlusion. Implants were early loaded after 2 months. Final restorations were provided 8 months after implant placement. Outcome measures were prosthesis and implant failures as well as biological and prosthetic complications recorded by non-blinded assessors. Blinded assessors evaluated peri-implant bone and soft-tissue levels. Results: Fifty-two implants were immediately loaded and 52 early loaded. One patient of the early loaded group dropped out after the 1-year recall. One single immediately loaded implant failed 2 months after placement. Only one complication (iatrogenic peri-implantitis) occurred in one patient of the early loading group. Both groups gradually lost peri-implant bone in a highly statistically significant way at 2, 8 and 14 months and at 4 and 5 years. After 5 years, patients of both groups had lost an average of 1.2 mm of peri-implant marginal bone. There were no statistically significant differences in peri-implant bone and soft-tissue level changes between the 2 groups. At 5 years, there was a statistically significant recession (0.2 mm) of the vestibular soft tissues from baseline (delivery of the final restorations 8 months after implant placement) only for immediately loaded implants. Conclusions: In well maintained patients, complications are uncommon and healthy and stable periimplant tissues can be maintained for 5 years around immediately and early loaded implants. Keywords: dental implants, early loading, follow-up, immediate loading, partial edentulism Conflict-of-interest statement: This trial was independently designed and initiated by the investigators, however BIOMET 3i provided partial economic support at a later stage.