华西口腔医学杂志2025，Vol.43Issue(5)：613-619,7.DOI:10.7518/hxkq.2025.2025156
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 sub-stitute materials in alveolar bone defects
摘要
Abstract
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 in-dicators,and quality control,to provide guidance for professionals in the field.关键词
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分类
医药卫生引用本文复制引用
廖小毓,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,薛洋,胡开进,郑雪妮,王恩博,潘剑,邹多宏,赵吉宏,韩冰,刘昌奎..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[J].华西口腔医学杂志,2025,43(5):613-619,7.基金项目
国家自然科学基金(81970954) （81970954）
西安科技局重大专项(23LLRHZDZX0010) National Natural Science Foundation of China(81970954) （23LLRHZDZX0010）
Xi'an Municipal Science and Technology Bu-reau Major Special Project(23LLRHZDZX0010) （23LLRHZDZX0010）
