一种国产骨水平种植体单牙种植修复短期效果的多中心前瞻性临床试验  

A multicenter prospective clinical trial on the effect of domestic bone level implants on single tooth implantation and restoration

作　　者：施斌[1] 杨程雨 赵耀宇 晏奇 刘磊[2] 王伟[3] 白轶[1] 樊世锋[2] 顾新华[3] Shi Bin;Yang Chengyu;Zhao Yaoyu;Yan Qi;Liu Lei;Wang Wei;Bai Yi;Fan Shifeng;Gu Xinhua(State Key Laboratory of Oral&Maxillofacial Reconstruction and Regeneration,Key Laboratory of Oral Biomedicine Ministry of Education,Hubei Key Laboratory of Stomatology,School&Hospital of Stomatology,Wuhan University,Wuhan 430079,China;Department of Stomatology,the Third Hospital of Hebei Medical University,Shijiazhuang 050000,China;Department of Stomatology,The First Affiliated Hospital of Zhejiang University School of Medicine,School of Stomatology,and Key Laboratory of Oral Biomedical Research of Zhejiang Province,Hangzhou 310003,China)

机构地区：[1]武汉大学口腔医(学)院口颌系统重建与再生全国重点实验室,口腔生物医学教育部重点实验室,口腔医学湖北省重点实验室,武汉430079 [2]河北医科大学第三医院口腔科,石家庄050000 [3]浙江大学医学院附属第一医院口腔科·口腔医学院浙江省口腔生物医学研究重点实验室,杭州310003

出　　处：《中华口腔医学杂志》2024年第8期810-815,共6页Chinese Journal of Stomatology

摘　　要：目的探讨一种国产骨水平种植体修复单牙缺失的临床应用效果,为国产种植体的推广应用提供临床证据。方法设计前瞻性、多中心临床试验,2018年4月至2020年1月于武汉大学口腔医(学)院种植科、浙江大学医学院附属第一医院口腔科、河北医科大学第三医院口腔科进行。计划纳入100例受试者行国产骨水平种植体单牙种植修复,随访1年,评价种植成功率和其余相关指标。结果共筛选142例受试者,最终纳入100例,其中男性43例,女性57例,年龄(47.0±12.2)岁。100例受试者中98例完成1年随访(98.0%),2例因种植体松动脱落提前结束试验(2.0%)。98例完成1年随访的患者均种植成功,种植成功率为98.0%(98/100)。患者对修复后总体效果满意。结论本项研究使用的国产骨水平种植体单牙种植修复短期临床效果较好。Objective To evaluate the clinical application effects of a domestic bone-level implant system for restoring single tooth loss,and provide clinical evidence for the promotion and application of domestic implants.Methods A prospective,multicenter clinical trial was conducted from April 2018 to January 2020 in three institutions:Department of Oral Implantology,School&Hospital of Stomatology,Wuhan University,Department of Stomatology,The First Affiliated Hospital of Zhejiang University School of Medicine,and Department of Stomatology,The Third Hospital of Hebei Medical University.The trial planned to include 100 patients for single tooth implantation and restoration,followed up for 1 year,to evaluate the implantation success rate and other related outcomes.Results This study screened a total of 142 patients and ultimately included 100,comprising 43 males and 57 females with age of(47.0±12.2)years.Ninety-eight out of 100 patients completed a one-year follow-up(98.0%),while 2 patients terminated the trial early due to implant loosening(2.0%).After a one-year follow-up,the implants of the 98 patients were all functioning successfully,with a success rate of 98.0%(98/100).The patients were satisfied with the overall restoration effect.Conclusions This study indicates that the domestic bone-level implant system has achieved favorable short-term clinical outcomes for single-tooth implantation and restoration.

关 键 词：牙种植体 牙种植体 单牙 牙槽骨质丢失 患者满意度 成功率 

分 类 号：R783.6[医药卫生—口腔医学]