Patient-centred outcomes comparing transmucosal implant placement with an open approach in the maxilla: a prospective, non-randomized pilot study.

It was the aim of the study to assess differences in patient morbidity between transmucosal implant placement and implant installation after elevation of mucoperiosteal flaps. In five of the patients, implants were placed in the maxilla transmucosally using a CAD/CAM surgical template [test group (TG)]. In the remaining five patients, the implants were installed after the elevation of mucoperiosteal flaps [control group (CG)]. Directly after surgery, at days 1 and 7 after surgery the patients rated pain and discomfort on a visual analogue scale (0=minimal pain and discomfort, 100=maximal pain and discomfort). Optical three-dimensional images were assessed preoperatively and at days 1 and 7 after surgery to determine the visible soft tissue swelling of the upper lip and cheeks. Directly postoperatively, the mean pairwise difference between both groups in view of pain and discomfort ratings (control minus test) was 45.6 (SD, 20.7). At days 1 and 7, the mean differences were 51.6 (SD, 21.8) and 19 (SD, 8), respectively. The overall test of the area under curve (AUC) against the null hypothesis 'AUC of pairwise differences of pain score over study time equals null' yielded a significant difference (P=0.01). The mean pairwise difference between both groups in view of soft tissue volume increase was 6.1 (SD, 2) cm(3) at day 1 after surgery and 4.6 (SD, 1.2) cm(3) at day 7. The overall test of the AUC against the null hypothesis 'AUC of pairwise differences of oedema measurements over study time equals null' yielded a significant difference (P=0.002). Within the limitations of this pilot study, it could be shown that transmucosal implant placement reduces patient morbidity significantly compared with an open approach.