COMPUTER-GUIDED VS. FREEHAND PLACEMENT OF IMMEDIATELY LOADED DENTAL IMPLANTS: 10-YEAR REPORT FROM A RANDOMIZED CONTROLLED TRIAL

PURPOSE. To compare planning and patient rehabilitation using 3D implant planning software and dedicated surgical templates versus conventional freehand implant placement for the rehabilitation of partially or fully edentulous patients using flapless or miniflap procedures and immediate loading. MATERIALS AND METHODS. Patients requiring at least two implants to be restored with a single prosthesis, having at least 7 mm of bone height and 4 mm in bone width were consecutively enrolled. Patients were randomized according to a parallel-group design into two groups: Computer-guided group or conventional freehand group. Implants were loaded immediately with a provisional prosthesis, replaced by a definitive prosthesis 4 months later. Outcome measures were implant and prosthesis failures, any complications, marginal bone levels, number of treatment sessions, duration of treatment, post-surgical pain and swelling, intake of painkillers, surgical and prosthetics times, time required to solve complications, and patient satisfaction. Patients were followed up to 10 years after loading. RESULTS. Ten patients (32 implants) were randomized to the computer-guided group and 10 patients (30 implants) to the freehand group. At the 10-year follow-up, three patients (five implants) in the computer-guided group and three patients (seven implants) in the freehand group dropped out. One prosthesis in the freehand group was remade versus none in the computer-guided group (P = 1). Two implants failed in two patients from the freehand group versus no implant failure in the computer-guided group (P = 0.4615). Four patients had four complications in the freehand group versus five patients with six complications in the computer-guided group. All complications were successfully resolved. The difference between groups was not statistically significant (P = 1). Ten years after loading, the mean marginal bone loss was 1.01±0.51 mm in the computer-guided group and 1.54±0.36 mm in the freehand group. The difference was statistically significant (difference 0.53 mm; 95% CI: 0.16 to 0.89 mm; P = 0.044). Patients’ self-reported post-surgical pain (P = 0.037) and swelling (P = 0.007) were statistically higher in the freehand group. There were no statistically significant differences between groups in either the number of sessions from patient recruitment to delivery of the final prosthesis, the number of days from the initial CBCT scan to implant placement, the pain medication intake, or the time taken for surgery/prosthetics. At the 10-year follow-up, all patients declared that they were fully satisfied with the function and aesthetics of their final prostheses. CONCLUSIONS. The results at 10-year follow-up confirm that both approaches achieved positive results, although post-operative pain and swelling were statistically higher at the freehand-treated sites, and less marginal bone loss (0.5 mm) was observed in the computer-guided group at 10-year follow-up.