Romito Giuseppe Alexandre, Hassan Mohamed Ahmed, de Castro Galvão Corrente Marina Nogueira, Aoun Julia Dahdal, Sapata Vitor Marques, Nishyama Roger, Villar Cristina Cunha
Discipline of Periodontics, School of Dentistry, University of São Paulo, São Paulo, Brazil.
Discipline of Prosthodontics, School of Dentistry, University of São Paulo, São Paulo, Brazil.
J Clin Periodontol. 2025 Oct;52(10):1374-1385. doi: 10.1111/jcpe.14204. Epub 2025 Jul 20.
CBCT and CAD/CAM technologies have allowed the development of patient-specific implants requiring no drilling. This prospective study evaluated the safety and effectiveness of a novel, drill-free, one-piece root-analogue implant designed using a digital workflow and manufactured additively.
Patients with non-restorable maxillary anterior or premolar teeth requiring extraction and implant placement were included. Implant design was based on pre-extraction cone-beam computed tomography (CBCT) and optical impressions of the target tooth, adjacent teeth and opposing dentition, and post-extraction scanning of the extracted tooth. Within 14 days post extraction, the implant was designed, manufactured and placed into the alveolar socket, and a temporary crown was installed out of occlusion. The final crown was installed after 3 months. Clinical parameters, including plaque index, gingival index, bleeding on probing, suppuration, peri-implant mucosal margin position, probing depth, probing depth relative to the implant platform and keratinised tissue, were collected at 3, 6, 9, 12 and 24 months post loading. Radiographic measurements as well as patient- and clinician-reported outcomes were also assessed.
The study cohort comprised 12 patients. The cumulative implant survival and success rates reached 100% and 90%, respectively. Clinical and radiographic parameters consistently indicated healthy peri-implant tissues. Patient-reported outcomes demonstrated high satisfaction and minimal discomfort. Visual analogue scale (VAS) scores for overall satisfaction remained high, with a median of 10 at final restoration delivery (95% CI: 10.00-10.00) and at the 24-month follow-up (95% CI: 9.70-10.01).
These patient-specific, root-analogue implants demonstrated both safety and effectiveness, along with high patient satisfaction rates up to 24 months post loading.
锥形束计算机断层扫描（CBCT）和计算机辅助设计/计算机辅助制造（CAD/CAM）技术推动了无需钻孔的个性化种植体的发展。本前瞻性研究评估了一种采用数字工作流程设计并通过增材制造的新型一体式牙根模拟种植体的安全性和有效性。
纳入需要拔除上颌前牙或前磨牙并植入种植体的不可修复患者。种植体设计基于拔牙前的锥形束计算机断层扫描（CBCT）以及目标牙、邻牙和对颌牙列的光学印模，以及拔牙后对拔除牙的扫描。拔牙后14天内，设计、制造种植体并植入牙槽窝，安装临时冠使其不接触咬合。3个月后安装最终冠。在加载后3、6、9、12和24个月收集临床参数，包括菌斑指数、牙龈指数、探诊出血、化脓、种植体周围黏膜边缘位置、探诊深度、相对于种植体平台和角化组织的探诊深度。还评估了影像学测量以及患者和临床医生报告的结果。
研究队列包括12名患者。种植体的累积生存率和成功率分别达到100%和90%。临床和影像学参数始终表明种植体周围组织健康。患者报告的结果显示满意度高且不适最小。总体满意度的视觉模拟量表（VAS）评分一直很高，最终修复交付时中位数为10（95%置信区间：10.00 - 10.00），24个月随访时为9.70 - 10.01（95%置信区间）。
这些个性化的牙根模拟种植体在加载后24个月内显示出安全性和有效性，以及较高的患者满意度。
