The Cortical Shield for Facial Bone Reconstruction of Severely Damaged Sockets with Simultaneous Implant Placement: A Feasibility Clinical Trial.

Abstract

To evaluate a novel proof-of-principle technique of simultaneous bone regeneration and implant placement in severely damaged sockets. This study consisted of patients who required a single implant and presented with severe facial bone loss. Individuals were randomly assigned to either the immediate or delayed implant placement protocol. Socket reconstruction and simultaneous implant placement were performed through periosteal-guided bone regeneration. Implants were encased in a customized shield of autogenous cortical bone harvested from an adjacent site. Re-entry surgery was performed at 12 to 18 weeks. Peri-implant tissues and pink esthetics were assessed following established success criteria. Of the 34 patients treated, 28 patients-consisting of 15 women and 13 men with an average age of 50.8 ± 4.5 years-continued to the final follow-up. All individuals showed new facial cortical bone regeneration at second-stage implant surgery after an average healing time of 14.9 ± 2.2 weeks (range: 12 to 18 weeks). Implants remained stable after loading. Success rates were 100% at 12 months. Mean pink esthetic score (PES) was 7.8 ± 1.2 (range: 6 to 9 on a scale of 0 to 10). Linear regression analysis showed that provisionalization and attachment loss are independent risk factors affecting pink esthetics (P < .01). Mild and moderate/severe attachment loss decrease pink esthetic scores by 0.9 and 1.7 points, respectively (95% CI: 0.2-1.5; P < .01). The use of provisional restorations improves pink esthetic scores by 1.6 points (95% CI: 0.8-2.4; P < .001). A PES > 7 was four and five times more likely to be expected for delay and immediate implants, respectively, if the implant had a provisional restoration delivered post-second-stage (RR = 4 to 5; 95% CI: 1-31; P = .07; P = .02). Cramér's V test showed a strong association between lack of implant provisionals and low pink esthetic scores (≤ 7, value = 0.7; P = .02). Facial implant transparency at follow-up was absent, and all implants had a band of keratinized tissue > 2 mm. Facial bone regeneration and simultaneous implant placement is feasible in severely damaged sockets through periosteal-guided bone regeneration after a short healing period following immediate or delayed protocols. The assisted regenerated intrasocket bone allows for functional implant stability. Adjacent tooth attachment loss and lack of implant provisionalization negatively impacts pink esthetics. The proposed approach decreases costs, morbidity, and treatment duration and eliminates the need for multi-stage approaches.