Purpose: To compare implants with machined vs roughened surfaces placed flapless in totally edentulous jaws and immediately restored with metal-resin screw-retained cross-arch prostheses. Mandibles were rehabilitated with two implants (Fixed-on-2 or Fo2) and maxillae with three implants (Fixed-on-3 or Fo3). Materials and methods: Forty edentulous or to be rendered edentulous patients (20 in the mandible and 20 in the maxilla) were randomised to the machined group (20 patients: 10 mandibles and 10 maxillae) and to the roughened group (20 patients: 10 mandibles and 10 maxillae) according to a parallel group design. To be immediately loaded implants had to be inserted with a minimum torque of 60 Ncm. Outcome measures were prosthesis and implant failures, complications and peri-implant marginal bone level changes evaluated up to 1 year post-loading. Results: Flaps were raised in four patients from the machined group. Four prostheses on machined implants and three on roughened implants were delayed for loading because a sufficient insertion torque was not obtained. There were no dropouts 1 year after loading. Two maxillary machined implants were lost in two patients (difference in proportions = 0.10; 95% CI = -0.03 to 0.23; P (Fisher's exact test) = 0.487); one maxillary Fo3 prosthesis on machined implants and one mandibular Fo2 prosthesis on roughened implants had to be remade (difference in proportions = 0; 95% CI = -0.14 to 0.14; P (Fisher's exact test) = 1.000). Five patients with machined implants had six complications vs seven patients who had eight complications at roughened implants (difference in proportions = -0.10; 95% CI = -0.38 to 0.18; P (Fisher's exact test) = 0.731). There were no statistically significant differences for implant failures, prosthetic failures or complications between groups. There were no statistically significant differences for marginal peri-implant bone levels between the two groups (estimate of the difference = -0.06 mm; 95% CI = -0.23 to 0.10; P (ANCOVA) = 0.445), with both groups losing marginal bone in a statistically significant way (0.35 ± 0.23 mm for machined and 0.42 ± 0.27 mm for roughened surface). Conclusions: These preliminary results suggest that immediately loaded cross-arch prostheses can be supported by only two mandibular or three maxillary dental implants at least up to 1 year post-loading, independently of the type of implant surface used. Longer follow-ups are needed to understand whether one of the two-implant surfaces is preferable.
Schlagwörter: dental implants, flapless, immediate loading, machined surface, rough implant surface
Conflict of interest statement: Sweden & Martina, the manufacturer of the implants used in this investigation, supported this trial, however data belonged to the authors and by no means did the sponsor interfere with the conduct of the trial or the publication of its results.
