牙槽骨缺损骨充填或移植替代材料临床随机对照试验设计与评价方法的专家共识
Expert consensus on clinical randomized controlled trial design and evaluation methods for bone grafting or substitute materials in alveolar bone defects
作者：廖小毓, 薛洋, 郑雪妮, 王恩博, 潘剑, 邹多宏, 赵吉宏, 韩冰, 刘昌奎, 华红, 梁新华, 尚姝环, 王文梅, 刘水冰, 王虎, 王培, 冯斌, 巨佳, 张林林, 胡开进
Author：Liao Xiaoyu, Xue Yang, Zheng Xueni, Wang Enbo, Pan Jian, Zou Duohong, Zhao Jihong, Han Bing, Liu Changkui, Hua Hong, Liang Xinhua, Shang Shuhuan, Wang Wenmei, Liu Shuibing, Wang Hu, Wang Pei, Feng Bin, Ju Jia, Zhang Linlin, Hu Kaijin
收稿日期：2025-04-19 年卷（期）页码：2025,43(5):613-613-619
期刊名称：华西口腔医学杂志
Journal Name：West China Journal of Stomatology
关键字：牙槽骨缺损,拔牙后位点保存,临床试验,牙槽骨缺损测量,骨移植材料,
Key words：alveolar bone defect,ridge preservation,clinical trial,alveolar bone defect measurement,bone graft biomaterials,
基金项目：国家自然科学基金(81970954);西安科技局重大专项(23LLRHZDZX0010)
中文摘要
骨移植是一种治疗骨缺损的主要方法，其中，异种骨材料由于来源丰富、加工储存便利、避免二次手术等优势被广泛应用于临床骨缺损的治疗中。随着国产化进程的推进及进口产品的有限性，越来越多的骨充填或移植替代材料进入临床试验中。为了加强对医疗器械临床试验的管理，维护医疗器械临床试验过程中受试者权益，保障临床试验科学有效地进行，相关专家起草本共识，从设计原则、受试者纳排标准、观察时间、疗效评价指标、安全性评价指标、质量控制等方面总结相关临床经验，以期为广大同仁提供参考。
英文摘要
Bone grafting is a primary method for treating bone defects. Among various graft materials, xenogeneic bone substitutes are widely used in clinical practice due to their abundant sources, convenient processing and storage, and avoidance of secondary surgeries. With the advancement of domestic production and the limitations of imported products, an increasing number of bone filling or grafting substitute materials isentering clinical trials. Relevant experts have drafted this consensus to enhance the management of medical device clinical trials, protect the rights of participants, and ensure the scientific and effective execution of trials. It summarizes clinical experience in aspects, such as design principles, participant inclusion/exclusion criteria, observation periods, efficacy evaluation metrics, safety assessment indicators, and quality control, to provide guidance for professionals in the field.
下一条：儿童口腔治疗中局部麻醉应用的专家共识
【关闭】
