ObjectiveTo compare fully guided flapless implant surgery using a light‐cured surgical guide (FG group) with partially guided open flap surgery (PG group) in the posterior maxilla when performing simultaneous sinus floor elevation in terms of the accuracy, time requirements, and patient/clinician‐reported outcomes (PROMs and CROMs).Materials and MethodsIn this study, 56 tissue‐level implants were placed with crestal sinus floor elevation in 56 patients at single‐tooth sites, with 28 implants allocated to the PG group and 28 to the FG group. The deviations of the placed implants from the virtually planned positions were measured at the implant platform and apex and for the angular deviation. The presurgical preparation time and the duration of surgery were measured. PROMs and CROMs were made by administering questionnaires at multiple time points.ResultsHorizontal deviations at the platform and apex and the angular deviation were significantly smaller in the FG group than the PG group (p < .05). Presurgical preparation and surgery times were significantly shorter in the FG group (p < .001). Patient satisfaction and willingness to receive repeat treatment were significantly better in the FG group than in the PG group (p < .005 and .025, respectively). Clinicians were more satisfied in the FG group than the PG group (p < .05).ConclusionWhen placing an implant with sinus floor elevation, the flapless approach using a fully guided surgical system can be more accurate, faster, and increase the satisfaction of both the clinician and patient compared to the partially guided surgery.

中文翻译：

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关于定制的、完全引导的种植体系统对无瓣牙槽嵴窦底提升的疗效的随机对照试验：准确性和患者报告的结果


目的比较使用光固化手术导板的全引导无瓣种植手术 （FG 组） 与部分引导下上颌后牙开瓣手术 （PG 组） 在同时进行窦底提升时，在准确性、时间要求和患者/临床医生报告的结果 （PROM 和 CROMs） 方面。材料和方法在本研究中，56 例患者在单牙部位放置了 56 个组织水平的种植体，并抬高了牙槽嵴窦底，其中 28 个种植体分配给 PG 组，28 个分配给 FG 组。在种植体平台和根尖处测量放置的种植体与虚拟计划位置的偏差以及角度偏差。测量术前准备时间和手术持续时间。PROMs 和 CROMs 是通过在多个时间点进行问卷调查来制作的。结果FG 组平台和顶点的水平偏差以及角度偏差显著小于 PG 组 （p < .05）。FG 组的术前准备和手术时间显著缩短 （p < .001）。FG 组的患者满意度和接受重复治疗的意愿显著优于 PG 组 （p 分别为 < .005 和 .025）。临床医生对 FG 组的满意度高于 PG 组 （p < .05）。结论当放置窦底抬高的种植体时，与部分引导手术相比，使用全引导手术系统的无翻瓣入路可以更准确、更快速，并提高临床医生和患者的满意度。