Center of General, Special Care, & Geriatric Dentistry, Center of Dental Medicine, University of Zurich, Zurich, Switzerland.
Division of Gerodontology and Removable Prosthodontics, University Clinics of Dental Medicine, University of Geneva, Geneva, Switzerland.
Clin Oral Implants Res. 2020 Dec;31(12):1207-1222. doi: 10.1111/clr.13668. Epub 2020 Oct 3.
This randomized controlled trial (RCT) aimed to demonstrate the non-inferiority of mandibular 2-implant overdentures (IODs) on a CAD-CAM milled bar with long distal extensions (MBDE) against IODs on retentive anchors (RA).
Forty edentulous participants rehabilitated with a maxillary conventional denture and a mandibular 2-IOD participated in this trial. They were randomized into two groups [Control group (CG): RA + gold matrices; Experimental group (EG): MBDE + gold clip]. The outcomes included implant survival rate (ISR), chewing efficiency [quantitative (VoH) and subjective (SA) assessments], peri-implant marginal bone levels (PI-MBL), maximum bite force (MBF), and patient-reported outcomes [oral health impact profile (OHIP-EDENT), and denture satisfaction index (DSI)]. Outcomes were recorded at baseline (BL), two weeks (T ), 6 months (T ), and at 1 year (T ) after the intervention. Intra- and inter-group analyses were performed using regression models with ⍺=0.05.
38 participants completed the T visit (CG: n = 19, age = 74.7 ± 7.8 years; EG: n = 19, age = 70.3 ± 10.7 years). At T , there was no implant loss in either of the groups (ISR = 100%). There were no significant differences between the groups for the PI-MBL changes (p = .754). Improvements occurred faster in the EG than in the CG, but over the observation time, there were no differences between the trial groups for VoH, MBF, OHIP-EDENT, and the DSI, except for SA being significantly better in the EG group (p = .022).
The results of this RCT confirm that mandibular 2-IODs with a CAD-CAM milled bar with long distal extensions are not an inferior treatment to the conventional IODs on retentive anchors in the short term (1 year).
本随机对照试验（RCT）旨在证明在 CAD-CAM 铣削长远中延伸杆（MBDE）上使用下颌 2 颗种植体覆盖义齿（IOD）与使用固位锚（RA）上的 IOD 相比不劣效。
本试验纳入 40 名上颌常规义齿和下颌 2 颗种植体覆盖义齿修复的无牙颌参与者。他们被随机分为两组[对照组（CG）：RA+金嵌体；实验组（EG）：MBDE+金夹]。结果包括种植体生存率（ISR）、咀嚼效率[定量（VoH）和主观（SA）评估]、种植体边缘骨水平（PI-MBL）、最大咬合力（MBF）和患者报告的结果[口腔健康影响概况（OHIP-EDENT）和义齿满意度指数（DSI）]。在干预后 2 周（T ）、6 个月（T ）和 1 年（T ）时记录基线（BL）、时的结果。使用 ⍺=0.05 的回归模型进行组内和组间分析。
38 名参与者完成了 T 访视（CG：n=19，年龄 74.7±7.8 岁；EG：n=19，年龄 70.3±10.7 岁）。在 T 时，两组均无种植体脱落（ISR=100%）。两组之间的 PI-MBL 变化无显著差异（p=0.754）。EG 组的改善速度快于 CG 组，但在观察期内，两组在 VoH、MBF、OHIP-EDENT 和 DSI 方面无差异，除了 EG 组的 SA 明显更好（p=0.022）。
本 RCT 的结果证实，在短期内（1 年），CAD-CAM 铣削长远中延伸杆上的下颌 2 颗种植体覆盖义齿与传统 RA 上的 IOD 相比并不劣效。
