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Purpose: To compare planning and patient rehabilitation using 3D implant planning software and dedicated surgical templates with conventional freehand implant placement for the rehabilitation of partially or fully edentulous patients using flapless or mini-flap 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 randomised according to a parallel group study design into two groups: computerguided group or conventional freehand group. Implants were loaded immediately with a provisional prosthesis, replaced by a definitive prosthesis 4 months later. Outcome measures assessed by a blinded independent assessor were: implant and prosthesis failures, any complications, marginal bone levels, number of treatment sessions, duration of treatment, post-surgical pain and swelling, consumption of pain killers, surgical and prosthetic time, time required to solve complications, and patient satisfaction. Patients were followed up to 5 years after loading., Results: Ten patients (32 implants) were randomised to the computer-guided group and 10 patients (30 implants) were randomised to the freehand group. At the 5-year follow-up examination one patient of the computer-guided group and one of the freehand group dropped-out (both moved to another country). No prostheses failed during the entire follow-up. Two implants failed in the conventional group (6.6%) vs none in the computer-guided group (P = 0.158). Ten patients (five in each group) experienced 11 complications (six in the computer-guided group and five in the freehand group), that were successfully solved. Differences between groups for implant failures and complications were not statistically significant. Five years after loading, the mean marginal bone loss was 0.87 mm ± 0.40 (95% CI: 0.54 to 1.06 mm) in the computer-guided group and 1.29 mm ± 0.31 (95% CI: 1.09 to 1.51 mm) in the freehand group. The difference was statistically significant (difference 0.42 mm ± 0.54; 95% CI: 0.05 to 0.75; P = 0.024). Patient self-reported post-surgical pain (P = 0.037) and swelling (P = 0.007) were found to be statistically significant higher in patients in the freehand group. Number of sessions from patient's recruitment to delivery of the definitive prosthesis, number of days from the initial CBCT scan to implant placement, consumption of painkillers, averaged surgical, prosthetic, and complication times, were not statistically significant different between the groups. At the 5-year followup, all the patients were fully satisfied with the function and aesthetics of their definitive prostheses., Conclusions: Both approaches achieved successful results over the 5-year follow-up period. Statistically higher post-operative pain and swelling were experienced at sites treated freehand with flap elevation. Less marginal bone loss (0.4 mm) was observed in the computer-guided group, at 5 years follow-up., Competing Interests: This trial was completely self-funded and all the authors declare no conflicts of interest.

Purpose: To evaluate the safety and clinical effectiveness of a novel dental implant system (GENESIS Implant System, Keystone Dental, Massachusetts, USA) using another dental implant system by the same manufacturer as a control (PRIMA Implant System, Keystone Dental)., Materials and Methods: A total of 53 patients requiring at least two single crowns had their sites randomised according to a split-mouth design to receive both implant systems at six centres. If implants could be placed with a torque superior to 40 Ncm they were to be loaded immediately with provisional crowns, otherwise after 3 months of submerged healing. Provisional crowns were replaced by definitive crowns 4 months after initial loading, when the follow-up period for the initial part of this study was completed. Outcome measures were crown/implant failures, complications, pink esthetic score (PES), peri-implant marginal bone level changes, plaque score, marginal bleeding, patients and preference of the clinician., Results: In total 53 PRIMA and 53 GENESIS implants were placed. Three patients dropped out but all of the remaining patients were followed up to 4-months post-loading. No PRIMA implant failed whereas four GENESIS implants failed. Only two complications were reported for PRIMA implants. There were no statistically significant differences for crown/implant failures (difference in proportions = 0.080; P (McNemar test) = 0.125) and complications (difference in proportions = -0.04; P (McNemar test) = 0.500) between the implant systems. There were no differences at 4-months post-loading for plaque (difference = -0.54, 95% CI: -3.01 to 1.93; P (Paired t-test) = 0.660), marginal bleeding (difference = -3.8, 95% CI: -7.63 to 0.019; P (Paired t-test) = 0.051), PES (difference = 0.47, 95% CI: -0.56 to 1.50; P (Paired t-test) = 0.365) and marginal bone level changes (difference in mm = -0.04, 95% CI: -0.33 to 0.26; P (Paired t-test) = 0.795). The majority of the patients (46) had no preference regarding the two implant systems evaluated. Three operators preferred GENESIS implants, two had no preference and one preferred GENESIS in medium and soft bone and PRIMA in hard bone., Conclusions: No statistically significant differences were observed between the systems' implant types, although four GENESIS implants failed versus none of the PRIMA type. Longer follow-ups of wider patient populations are needed to better understand whether there is an effective advantage with one of the two implant designs. Conflict-of-interest statement: This research project was originally funded by Keystone Italia, Dental spa (Verona, Italy), the manufacturer of the implants evaluated in this investigation. 
 
However, when Keystone Italia received the data of the present manuscript, they refused to honour the financial agreement for the present publication. Therefore, no further follow-ups of this trial will be considered. A legal action was initiated against Keystone Italia. The data belonged to the authors and by no means was the manufacturer allowed to interfere with the conduct of the trial or the publication of the results.