Guided implant surgery with R2Gate®: A multicenter retrospective clinical study with 1 year of follow-up

Abstract

Purpose: To present the results obtained with a novel sleeveless and keyless guided implant surgery system.

Methods: Inclusion criteria for this multicenter clinical retrospective study were fully or partially edentulous patients who had been treated with a sleeveless and keyless guided implant surgery system (R2Gate®, Megagen), and who had been rehabilitated with fixed restorations, with a minimum follow-up of 1 year. All surgeries and prosthetic procedures were conducted following the same protocol, and data were obtained from the patients' medical records. The outcomes were the fit and stability of the surgical guide, any intra-operative and immediate post-operative complications, any biologic and prosthetic complications that occurred during the 1-year follow-up period, implant survival, and prosthetic success.

Results: Sixty patients were selected for the installation of 124 implants, through a guided procedure: 66 sleeveless, keyless surgical guides were manufactured. The incidence of immediate intra-operative (lack of space: 12.1%; lack of implant stability 2.6%) and immediate post-operative (pain and discomfort: 6.6%; mild swelling 3.3%) complications was low. In total, 112/124 implants (90.3%) were successfully placed with a guided procedure, in 52 patients; among them, 82 (73.2%) were placed with a flapless procedure. Thirty fixtures supported single crowns (SCs), 42 fixed partial dentures (FPDs) and 52 full-arch (FA) restorations. Sixty-two fixed prosthetic restorations (30 SCs, 22 FPDs and 10 FAs) were delivered; among these restorations, 15 (24.1%) were subjected to immediate functional loading. All implants (100%) survived. Two implants had peri‑implant mucositis (1.6%), two SCs had abutment screw loosenings (1.6%), two FAs and one FPD had ceramic chipping/fracture (2.4%), for an overall prosthetic success amounting to 88.7%.

Conclusions: Within the limits of this study, this novel guided surgery system appeared to be clinically reliable; further studies are needed to confirm these results.

Statement of clinical relevance: The use of sleveless and keyless surgical guides can be clinically reliable and may be represent a valid option for the surgeon.

Keywords: Complications; Computer-assisted-design/computer-aided-manufacturing (CAD/CAM); Cone beam computed tomography (CBCT); Flapless surgery; Guided implant surgery; Immediate loading; Implants; Success; Survival.