口腔医疗器械临床试验方案设计要点的把控

基于口腔医学专业和口腔医疗器械的特点，探讨如何在口腔医疗器械临床试验方案的设计过程中把控纳排标准制定、对照设置、疗效评估、盲法设计、样本量计算等关键点。从口腔医疗器械临床试验起始阶段开始，理清思路，把控设计的要点，提升设计与实施的连贯性，以期防患于未然，提高临床试验质量。

Control of key points in designing protocol of clinical trials for dental medical devices

Based on the characteristics of stomatology and dental medical devices, the key points of clinical trial design for dental medical devices were discussed,such as establishing inclusion/exclusion criteria, control setting, treatment efficacy assessment, blinding design, sample size calculation. From the initial stage of clinical trials of dental medical devices, the key points of clinical trial design should be controlled by clarifying the clinical trial ideas to keep the consistency of design and implementation, so as to prevent the occurrence of problems and improve the quality of clinical trials.