Expert consensus on clinical randomized controlled trial design and evaluation methods for bone grafting or substitute materials in alveolar bone defects.
10.7518/hxkq.2025.2025156
- Author:
Xiaoyu LIAO
1
;
Yang XUE
2
;
Xueni ZHENG
2
;
Enbo WANG
3
;
Jian PAN
4
;
Duohong ZOU
5
;
Jihong ZHAO
6
;
Bing HAN
7
;
Changkui LIU
1
;
Hong HUA
3
;
Xinhua LIANG
4
;
Shuhuan SHANG
6
;
Wenmei WANG
8
;
Shuibing LIU
9
;
Hu WANG
4
;
Pei WANG
2
;
Bin FENG
2
;
Jia JU
2
;
Linlin ZHANG
10
;
Kaijin HU
1
Author Information
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 Clinical 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.
- Publication Type:Consensus Development Conference
- Keywords:
alveolar bone defect;
alveolar bone defect measurement;
bone graft biomaterials;
clinical trial;
ridge preservation
- MeSH:
Humans;
Bone Substitutes/therapeutic use*;
Randomized Controlled Trials as Topic/methods*;
Consensus;
Bone Transplantation;
Research Design
- From:
West China Journal of Stomatology
2025;43(5):613-619
- CountryChina
- Language:Chinese
-
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.
