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首页> 外文期刊>The Journal of Prosthetic Dentistry >Clinical evaluation of a newly designed single-stage craniofacial implant: a pilot study.
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Clinical evaluation of a newly designed single-stage craniofacial implant: a pilot study.

机译：新设计的单阶段颅面植入物的临床评估：一项初步研究。

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STATEMENT OF PROBLEM: Placing craniofacial implants in a 2-stage procedure requires an additional second-stage surgery that is tedious for patients and clinicians and results in additional cost. PURPOSE: The purpose of this study was to clinically evaluate the use of a newly designed craniofacial implant for retaining facial prostheses, placed in a single-stage surgical procedure. MATERIAL AND METHODS: Twenty-one newly designed craniofacial implants (OsteoCare Implant System) were placed in 7 patients, all seeking implant-retained auricular prostheses, using a single-stage surgical procedure. Modified O-ring abutments were directly screwed onto the implants at the time of surgery. Plastic washers were attached to the O-ring heads of the exposed abutments to avoid skin overgrowth to allow a single-stage surgical procedure. After a delayed loading period of 4 months, a silicone prosthetic ear was fabricated and retained using clips over the O-ring abutments. Implants and surrounding tissues were clinically evaluated at 1, 6, and 12 months following prosthesis insertion. The following were evaluated: periimplant abutment sebaceous crusting, periimplant abutment exudate, skin thickness, periimplant abutment tissue reaction, and implant mobility. Data was collected and statistically analyzed using the nonparametric Friedman's test for overall comparisons and Wilcoxon signed rank test for post hoc assessment of significance between follow-up periods. RESULTS: None of the implants failed to osseointegrate, providing a survival rate of 100%. Periimplant abutment sebaceous crusting values were significantly reduced at the 12-month test session (P<.05). Periimplant abutment skin thickness was also significantly reduced (P<.05) between the 6- and 12-month, and 1- and 12-month, follow-up visits. No significant difference was found throughout the follow-up period for periimplant abutment exudates and tissue reactions. None of the implants showed any signs of mobility throughout the study period. CONCLUSIONS: The use of the single-stage surgical procedure, together with the newly designed craniofacial implants, provided a high survival rate for an evaluation period of up to 2.5 years in the present investigation.
机译：问题陈述：将颅面部植入物分两阶段进行，需要进行额外的第二阶段手术，这对于患者和临床医生而言是乏味的，并导致额外的成本。目的：本研究的目的是在临床上评估一种新设计的颅面植入物在单阶段外科手术中用于保留面部假体的用途。材料与方法：将21例新设计的颅面植入物（OsteoCare植入系统）放置在7例患者中，所有患者均采用单阶段手术方法寻求保留植入物的耳廓假体。手术时将改良的O形环基台直接拧到植入物上。将塑料垫圈连接到裸露基台的O形圈头上，以避免皮肤过度生长，从而可以进行单阶段外科手术。在延迟4个月的加载时间后，制作了硅胶假体耳并使用夹子将其固定在O形环基台上。在植入假体后的第1、6和12个月对植入物和周围组织进行临床评估。评估以下内容：种植体周围基台皮脂结,、种植体周围基台渗出液，皮肤厚度，种植体周围基台组织反应和种植体活动性。收集数据并进行统计分析，使用非参数弗里德曼检验进行整体比较，Wilcoxon签署秩检验用于事后随访之间的显着性事后评估。结果：所有植入物均未发生骨整合，存活率为100％。在12个月的测试期间，种植体周围基台皮脂结皮值显着降低（P <.05）。在6个月和12个月以及1个月和12个月的随访期间，种植体周围基台的皮肤厚度也显着降低（P <.05）。在整个随访期内，种植体周围基台渗出液和组织反应均未发现明显差异。在整个研究期间，没有植入物显示出任何活动迹象。结论：单阶段手术程序与新设计的颅面植入物一起使用，在本研究中可提供高达2.5年评估期的高生存率。

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