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一项关于三种窄直径种植体用于下颌切牙区固定局部种植支持式修复体的一年期随机对照临床试验。

A One-Year Randomized Controlled Clinical Trial of Three Types of Narrow-Diameter Implants for Fixed Partial Implant-Supported Prosthesis in the Mandibular Incisor Area.

作者信息

Ahn Ji-Ho, Lim Young-Jun, Lee Jungwon, Baek Yeon-Wha, Kim Myung-Joo, Kwon Ho-Beom

机构信息

Department of Prosthodontics and Dental Research Institute, School of Dentistry, Seoul National University, Seoul 03080, Republic of Korea.

Department of Periodontology, One-Stop Specialty Center, Seoul National University Dental Hospital, Seoul 03080, Republic of Korea.

出版信息

Bioengineering (Basel). 2024 Mar 12;11(3):272. doi: 10.3390/bioengineering11030272.

Abstract

Narrow-diameter implants (NDI) serve as a solution for treating limited bone volume in the anterior mandible. This study aimed to evaluate the one-year clinical outcomes of various NDIs in the mandibular incisor area after immediate loading in partially edentulous patients. This single-center, prospective, single-blinded, randomized controlled trial study included 21 patients, with 7 patients in each of the following groups: control (BLT NC SLActive; Straumann), experimental group 1 (CMI IS-III Active S-Narrow; Neobiotech), and experimental group 2 (CMI IS-III Active Narrow; Neobiotech). Using full digital flow, two fixtures were placed in each patient and immediately provisionalized on the day of surgery. Evaluations encompassed periapical radiographs, implant stability quotient (ISQ), implant stability test (IST) readings, per-implant soft tissue health, patient satisfaction surveys, and esthetic score assessments. Definitive prostheses were delivered twelve weeks post-surgery (CRiS, number: KCT0007300). Following exclusions due to low stability values ( = 2), fixture failure ( = 5), and voluntary withdrawal ( = 1), the implant success rate for patients completing all clinical protocols stood at 100%. The resulting patient failure rates in the control, experimental group 1, and experimental group 2 were 50.0%, 42.9%, and 14.3%, respectively. There were no significant differences between the groups in terms of marginal bone loss, soft tissue health, patient satisfaction, and esthetic scores. Narrow implants showed superior clinical outcomes, followed by S-Narrow and Straumann implants. Calculated one-year survival rates at the implant level were 66.7% for the control group, 85.7% for experimental group 1, and 100% for experimental group 2. All three types of NDIs showed acceptable clinical and radiographic results during the year-long observation period.

摘要

窄径种植体(NDI)是治疗下颌前部骨量有限的一种解决方案。本研究旨在评估部分牙列缺损患者即刻负重后,下颌切牙区不同NDI的一年临床效果。这项单中心、前瞻性、单盲、随机对照试验研究纳入了21例患者,以下每组各7例:对照组(BLT NC SLActive;士卓曼)、实验组1(CMI IS-III Active S-Narrow;纽奥生物科技)和实验组2(CMI IS-III Active Narrow;纽奥生物科技)。采用全数字流程,为每位患者植入两颗种植体,并在手术当天即刻进行临时修复。评估内容包括根尖片、种植体稳定性商数(ISQ)、种植体稳定性测试(IST)读数、每个种植体周围的软组织健康状况、患者满意度调查和美学评分评估。术后12周安装最终修复体(CRiS,编号:KCT0007300)。由于稳定性值低(=2)、种植体失败(=5)和自愿退出(=1)而排除相关病例后,完成所有临床方案的患者种植成功率为100%。对照组、实验组1和实验组2的患者失败率分别为50.0%、42.9%和14.3%。各组在边缘骨吸收、软组织健康状况、患者满意度和美学评分方面无显著差异。窄种植体显示出更好的临床效果,其次是S-Narrow种植体和士卓曼种植体。种植体水平的计算一年生存率,对照组为66.7%,实验组1为85.7%,实验组2为100%。在为期一年的观察期内,所有三种类型的NDI均显示出可接受的临床和影像学结果。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9b50/10968635/87fd312c340b/bioengineering-11-00272-g001.jpg

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