EFFICACY OF IMPLANT SUPPORTED MAXILLOFACIAL PROSTHESES

描述(改编自申请人的摘要)：建议， 需要进行客观的结果评估，以确定 昂贵、耗时的外科重建程序和 种植体支持的牙修复体在接受治疗之前 口腔癌患者的选择方式。调查人员概述了一个 纵向研究检验三个假说：(1)传统牙科 假体将特定的口腔功能和感知恢复到 癌前水平；(2)种植体支持的修复体恢复口腔 功能和口腔知觉恢复到癌症手术前的水平； 传统义齿和种植体支持的修复体同样有效 恢复特定的口腔功能和知觉。总共62个 将招募早期口腔癌患者；此外，还有22名患者 需要部分上颌骨切除，40例需要部分侧方切除 下颌骨切除手术将会被登记。下颌骨的缺陷将会是 采用腓骨游离皮瓣手术重建。在经过一段时间的治疗后， 植入物将被放置并允许在未加载的情况下愈合六个月。 传统的牙科修复体将由患者制造和使用 在植入物暴露前的I期愈合过程中至少16周 装好了。在第二阶段手术后的几周内，患者将接受 种植体支持的牙修复体。一系列完整的口腔功能 测试和问卷将以四个时间间隔进行：(1) 消融手术前；(2)常规置入前一周 义齿修复；(3)传统义齿修复后16周 种植；和(4)种植义齿修复后16周 插入。所有患者将每隔6个月随访12-36次 月，建立种植成功率，使用寿命表分析。

DESCRIPTION (Adapted from the Applicant's Abstract): It is suggested that, objective outcome assessments are needed to determine the effectiveness of costly, time-consuming surgical reconstructive procedures and implant-supported dental prostheses prior to their acceptance as treatment modalities of choice for oral cancer patients. The investigators outline a longitudinal study to test three hypotheses: (1) the conventional dental prosthesis restores specified oral functions and perceptions to the pre-cancer levels; (2) the implant-supported dental prosthesis restores oral functions and oral perceptions to the pre-cancer surgery levels; and (3) the conventional denture and implant-supported prostheses are equally efficient in restoring specified oral functions and perceptions. A total of 62 patients with early oral cancer will be recruited; in addition, 22 patients requiring a partial maxillectomy and 40 requiring a partial lateral mandibulectomy will be enrolled. The mandibular defects will be reconstructed with fibula free flap surgery. Following a healing period, implants will be placed and permitted to heal unloaded for six months. Conventional dental prostheses will be fabricated and used by patients for at least 16 weeks during Phase I healing before the implants are exposed and loaded. A few weeks after Phase II surgery, the patients will receive implant-supported dental prostheses. A complete series of oral functional tests and questionnaires will be administered at four time intervals: (1) prior to ablative surgery; (2) one week before insertion of conventional denture prostheses; (3) 16 weeks after conventional dental prostheses insertion; and (4) 16 weeks after implant-supported dental prostheses insertion. All patients will be followed at 6 month intervals, for 12-36 months, to establish implant success rates, using life table analysis.