West China Journal of Stomatology ›› 2025, Vol. 43 ›› Issue (5): 613-619.doi: 10.7518/hxkq.2025.2025156

   

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. 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)

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

CLC Number: