Feasibility of immediate placement of single-tooth implants in the aesthetic zone: a1-year randomized controlled trial.

Abstract

To assess whether outcome of immediate implant placement and immediate provisionalization after 1year was non-inferior to immediate implant placement and delayed provisionalization regarding Marginal Bone Level (MBL). Forty patients with a failing tooth in the aesthetic zone were randomly assigned for immediate implant placement with immediate (n=20) or delayed (n=20) provisionalization. Follow-up was at 1month and after 1year. The study was powered to detect a difference in MBL of <0.9mm. Apart from MBL, soft tissue peri-implant parameters, aesthetic indexes and patient satisfaction were assessed. After 1year, MBL changes were -0.75±0.69 mesially and -0.68±0.65 distally mm for the immediate group and -0.70±0.64 and -0.68±0.64mm for the delayed group respectively (NS). Regarding differences in means, non-inferiority was observed after 1year (mesially: Group A versus B: difference in mean 0.08mm (95% CI -0.38 to 0.53, p=0.71 distally: Group A versus B: difference in mean 0.09mm (95% CI -0.37 to 0.56mm, p=0.66).No significant differences in the other outcome variables were observed. This study showed that immediate placement and immediate provisionalization was non-inferior to immediate placement with delayed provisionalization. In addition, although not powered for these outcome variables, no clinically relevant differences in other outcomes were observed (www.isrtcn.com: ISRCTN57251089).