Trueness of implant placement, safety and surgeon experience with dynamic computer-assisted implant surgery : a prospective multi-centre cohort study

PURPOSE: This prospective multi-centre cohort study aims to evaluate the trueness and safety of implant placement using a Dynamic Navigation System (DNS) for implant bed preparation. MATERIALS AND METHODS: A total of 109 dental implants were inserted using a DNS for implant bed preparation in 76 patients by five experienced surgeons in four study centres. Before implantation, a preoperative CBCT scan was performed for each patient. This was subsequently aligned with an intraoral scan. After digital planning of the implant position, a holding tray for the intra-oral marker was designed and printed with a 3D printer. Procedure duration as well as adverse events were recorded. After implant bed preparation with DNS, the implants were placed in a freehand manner. Postoperative surface scans were superimposed onto the pre-operative planning data to evaluate the angular and spatial deviations. Descriptive statistics were followed by a one-sided, one-sample t-test to compare the data with performance goals extracted from literature-based benchmark data from freehand surgery. RESULTS: The overall mean angular deviation was 3.37°±2.01° with a minimum of 0.20° and a maximum of 11.10°. The mean mesiodistal and orovestibular deviation at implant tip was 1.18 ± 0.66 mm. 3D deviation at implant base showed a mean ± SD of 1.24 ± 0.65 mm. No Serious Adverse Device Effects (SADE) were reported. The angular and mesiodistal, and orovestibular deviations were significantly better than the performance goals from freehand surgery (P<.001). The mean VAS was of 87.5 ± 14.3. CONCLUSIONS: The study-related DNS demonstrates trueness, safety and surgeon satisfaction.