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

doi:10.7518/hxkq.2025.2025156

华西口腔医学杂志 ›› 2025, Vol. 43 ›› Issue (5): 613-619.doi: 10.7518/hxkq.2025.2025156

• 专家共识 •

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

廖小毓¹(), 薛洋², 郑雪妮², 王恩博³, 潘剑⁴, 邹多宏⁵, 赵吉宏⁶, 韩冰⁷, 刘昌奎¹, 华红³, 梁新华⁴, 尚姝环⁶, 王文梅⁸, 刘水冰⁹, 王虎⁴, 王培², 冯斌², 巨佳², 张林林¹⁰, 胡开进¹()

^1.西安医学院口腔医学院，西安医学院第三附属医院，西安 710021
^2.口颌系统重建与再生全国重点实验室，国家口腔疾病临床医学研究中心，陕西省口腔疾病临床医学研究中心，空军军医大学第三附属医院口腔颌面外科，西安 710032
^3.北京大学口腔医学院·口腔医院口腔颌面外科，北京 100081
^4.口腔疾病防治全国重点实验室国家口腔医学中心国家口腔疾病临床医学研究中心四川大学华西口腔医院，成都 610041
^5.上海交通大学医学院附属第九人民医院，上海 200011
^6.武汉大学口腔医院口腔外科，武汉 430079
^7.吉林大学口腔医院口腔颌面外科，长春 130021
^8.南京大学医学院附属口腔医院，南京 210093
^9.空军军医大学药学系药理学教研室，西安 710032
^10.西安未央德雅正尚口腔门诊部，西安 710021

收稿日期:2025-04-19 修回日期:2025-07-21 出版日期:2025-10-01 发布日期:2025-10-21
通讯作者: 胡开进 E-mail:1258152408@qq.com;hukaijin2015@126.com
作者简介:廖小毓，助教，硕士，E-mail：1258152408@qq.com|胡开进，教授、主任医师、博士生导师，兼任国际牙医师学院院士、西安医学院口腔医学院名誉院长、西安医学院第三附属医院名誉院长。中华口腔医学会牙及牙槽外科专业委员会首届主任委员、中华口腔医学会第七届口腔颌面外科专业委员会副主任委员，陕西省口腔医学会牙槽外科专业委员会首届主任委员、陕西省口腔医学会第二届口腔颌面外科专业委员会主任委员。教育部高等学校口腔医学类专业教学指导委员会委员，国家自然科学基金及国家科技奖评审专家，国家精品课程主讲教授。研究生统编教材《牙及牙槽外科学》及本科统编教材《口腔颌面外科学配套光盘》主编，住院医师规范化培训教材《口腔颌面外科分册》编委，《中国口腔颌面外科杂志》等8本杂志编委。发表教学和科研论文325篇，其中SCI收录60余篇；出版专著40部，其中主编及主译专著20部。获国家、军队、省部级研究课题22项，获国家、军队、省部级教学及科研奖励22项，获国家专利28项，主持国家标准及规范5项。
基金资助:
国家自然科学基金(81970954);西安科技局重大专项(23LLRHZDZX0010)

Expert consensus on clinical randomized controlled trial design and evaluation methods for bone grafting or substitute materials in alveolar bone defects

Liao Xiaoyu¹(), Xue Yang², Zheng Xueni², Wang Enbo³, Pan Jian⁴, Zou Duohong⁵, Zhao Jihong⁶, Han Bing⁷, Liu Changkui¹, Hua Hong³, Liang Xinhua⁴, Shang Shuhuan⁶, Wang Wenmei⁸, Liu Shuibing⁹, Wang Hu⁴, Wang Pei², Feng Bin², Ju Jia², Zhang Linlin¹⁰, Hu Kaijin¹()

^1.School of Stomatology, Xi’an Medical University; The Third Affiliated Hospital of Xi’an Medical University, Xi’an 710021, China
^2.State Key Laboratory of Oral and Maxillofacial Reconstruction and Regeneration, National Clinical Research Center for Oral Diseases, Shaanxi Cli-nical Research Center for Oral Diseases, Dept. of Oral and Maxillofacial Surgery, The Third Affiliated Hospital of Air Force Medical University, Xi’an 710032, China
^3.Dept. of Oral and Maxillofacial Surgery, Peking University School and Hospital of Stomatology, Beijing 100081, China
^4.State Key Laboratory of Oral Diseases & National Center for Stomatology & National Clinical Research Center for Oral Diseases & West China Hospital of Stomatology, Sichuan University, Chengdu 610041, China
^5.Shanghai Ninth People’s Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200011, China
^6.Dept. of Oral and Maxillofacial Surgery, Hospital of Stomatology, Wuhan University, Wuhan 430079, China
^7.Dept. of Oral and Maxillofacial Surgery, Hospital of Stomatology, Jilin University, Changchun 130021, China
^8.Stomatological Hospital Affiliated to Nanjing University Medical School, Nanjing 210093, China
^9.Dept. of Pharmacology, School of Pharmacy, Air Force Medical University, Xi’an 710032, China
^10.Xi’an Deya Zhengshang Dental Clinic, Xi’an 710021, China

Received:2025-04-19 Revised:2025-07-21 Online:2025-10-01 Published:2025-10-21
Contact: Hu Kaijin E-mail:1258152408@qq.com;hukaijin2015@126.com
Supported by:
National Natural Science Foundation of China(81970954);Xi’an Municipal Science and Technology Bureau Major Special Project(23LLRHZDZX0010)

摘要/Abstract

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。

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

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 indicators, and quality control, to provide guidance for professionals in the field.

Key words: alveolar bone defect, ridge preservation, clinical trial, alveolar bone defect measurement, bone graft biomaterials

中图分类号:

R782.1

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. 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.

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. Expert consensus on clinical randomized controlled trial design and evaluation methods for bone grafting or substitute materials in alveolar bone defects[J]. West China Journal of Stomatology, 2025, 43(5): 613-619.

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结果	主要观察指标评分	评价标准
优	3	填充材料与牙槽骨基质边缘有较大正常骨组织影像，首次CBCT灰度值明显小于末次数值，且术后6个月牙槽骨宽度与高度等于术后即刻牙槽骨宽度与高度
良	2	填充材料与牙槽骨基质边缘有正常骨组织影像，首次CBCT灰度值小于末次数值，且术后6个月牙槽骨宽度与高度小于术后即刻牙槽骨宽度与高度的10%
中	1	填充材料与牙槽骨基质边缘没有明显变化，首次CBCT灰度值等于或小于末次数值，且术后6个月牙槽骨宽度与高度小于术后即刻牙槽骨宽度与高度的15%
差	0	填充材料与牙槽骨基质边缘增大，首次CBCT灰度值明显大于末次数值，且术后6个月牙槽骨宽度与高度小于术后即刻牙槽骨宽度与高度的20%

结果	主要观察指标评分	评价标准
优	3	软组织完全成熟，色泽、质地与邻牙协调，角化龈宽度≥3 mm，黏膜厚度与邻近软组织一致
良	2	角化龈宽度2~3 mm，黏膜厚度较邻近软组织稍薄、色泽轻微差异
中	1	软组织颜色稍白或轻度向内凹陷，轻度瘢痕形成，无红肿、渗出
差	0	软组织明显萎缩或凹陷，黏膜菲薄透亮，形成瘘管、窦道

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

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