Khamis Mohamed Moataz, Medra Ahmed, Gauld John
Prosthodontic Department, Faculty of Dentistry, Alexandria University, Alexandria, Egypt.
J Prosthet Dent. 2008 Nov;100(5):375-83. doi: 10.1016/S0022-3913(08)60240-1.
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.
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.
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.
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.
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.
采用两阶段手术植入颅面植入物需要额外进行二期手术，这对患者和临床医生来说都很繁琐，而且会增加费用。
本研究的目的是对一种新设计的用于固定面部假体的颅面植入物进行临床评估，该植入物采用单阶段手术植入。
使用单阶段手术，将21个新设计的颅面植入物（OsteoCare植入系统）植入7例患者体内，所有患者均寻求植入物固定的耳廓假体。手术时将改良的O形环基台直接拧到植入物上。在暴露的基台的O形环头部连接塑料垫圈，以避免皮肤过度生长，从而实现单阶段手术。经过4个月的延迟加载期后，制作了一个硅胶假耳，并使用夹子固定在O形环基台上。在假体植入后的1、6和12个月对植入物和周围组织进行临床评估。评估内容包括：种植体周围基台皮脂腺结痂、种植体周围基台渗出物、皮肤厚度、种植体周围基台组织反应以及种植体活动度。收集数据并使用非参数Friedman检验进行总体比较，使用Wilcoxon符号秩检验进行随访期之间的事后显著性评估。
所有植入物均成功实现骨整合，生存率为100%。在12个月的测试阶段，种植体周围基台皮脂腺结痂值显著降低（P<0.05）。在6个月和12个月以及1个月和12个月的随访之间，种植体周围基台皮肤厚度也显著降低（P<0.05）。在整个随访期内，种植体周围基台渗出物和组织反应无显著差异。在整个研究期间，没有植入物显示出任何活动迹象。
在本研究中，单阶段手术与新设计的颅面植入物的使用在长达2.5年的评估期内提供了较高的生存率。
