Faculty of Dentistry, Université de Montréal, Canada.
Faculty of Dentistry, Universidade Federal do Rio Grande do Sul, Brazil.
J Dent. 2016 Jul;50:30-6. doi: 10.1016/j.jdent.2016.04.009. Epub 2016 Apr 22.
To provide 2-year clinical- and patient-oriented data with regard to mandibular overdenture assisted by 2 immediately loaded unsplinted implants.
In this pre-post design, Phase-I clinical trial, 18 edentate individuals (62.4±7.7years) received a new set of complete denture. Then, following standard procedures, 3 threaded implants (OsseoSpeed TX™, Dentsply Implants, Mölndal, Sweden) were placed in the mandible in each patient, and locator abutments (Zest Anchors LLC, Escondido, U.S.A.) were inserted on the right and left side implants. The midline implant served as a control for within-patient comparison. The immediate loading was conducted within 24h of surgery. Data were collected at baseline (T0), 12 (T1) and 24 (T2) months after immediate loading. The clinical outcomes included implant survival rate, crestal bone level changes and implant stability. These criteria were assessed through clinical and radiographic examinations as well as resonance frequency analysis. Patient-centered outcomes included patient satisfaction and oral health-related quality of life measured using validated questionnaires. Brunner-Langer approach was used for statistical analysis.
Implant survival rate for immediate loaded implants was 91.7% at 2-year follow-up. None of the unloaded implants failed. There was no statistically significant difference at baseline and follow-ups with regard to clinical outcomes between loaded and unloaded implants. Patient satisfaction and quality of life improved (p<0.0001) from baseline to 2-year follow-up.
Immediate loading protocol did not negatively affect clinical outcomes, satisfaction and quality of life of patients wearing 2-unsplinted-implant mandibular overdenture for 2 years. This conclusion requires confirmation by randomized control trials.
Mandibular overdenture assisted by two immediately-loaded unsplinted implants is successful treatment based on 2-year clinical and patient-based outcomes.
提供 2 年与临床和患者相关的下颌覆盖义齿使用 2 个即刻负载非夹板植入物的临床数据。
在这项前后设计的 I 期临床试验中，18 名无牙颌患者（62.4±7.7 岁）接受了新的全口义齿。然后，按照标准程序，在每位患者的下颌中放置 3 个螺纹种植体（OsseoSpeed TX™，Dentsply Implants，Mölndal，瑞典），并在右侧和左侧种植体上插入Locator 基台（Zest Anchors LLC，Escondido，美国）。中线种植体作为患者内比较的对照。即刻负载在手术后 24 小时内进行。数据在即刻负载后 12（T1）和 24 个月（T2）时采集。临床结果包括种植体存活率、牙槽骨水平变化和种植体稳定性。这些标准通过临床和影像学检查以及共振频率分析进行评估。以患者为中心的结果包括使用经过验证的问卷测量的患者满意度和口腔健康相关生活质量。采用 Brunner-Langer 方法进行统计学分析。
即刻负载种植体在 2 年随访时的存活率为 91.7%。未负载的种植体均未失败。在基线和随访时，负载和未负载种植体之间的临床结果没有统计学差异。从基线到 2 年随访，患者满意度和生活质量均有所提高（p<0.0001）。
在 2 年的随访中，即刻负载方案并未对佩戴 2 个非夹板下颌覆盖义齿的患者的临床结果、满意度和生活质量产生负面影响。这一结论需要通过随机对照试验来证实。
基于 2 年的临床和患者相关结果，使用 2 个即刻负载非夹板植入物的下颌覆盖义齿是一种成功的治疗方法。
