EFFICACY OF IMPLANT SUPPORTED MAXILLOFACIAL PROSTHESES

种植体支持的颌面假体的功效

• 批准号: 6176721
• 负责人: NEAL R GARRETT
• 金额: $ 33.66万
• 依托单位: UNIVERSITY OF CALIFORNIA LOS ANGELES
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-06-01 至 2002-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6176721
• 关键词: behavioral /social science research tag; cancer information system; cancer rehabilitation /care; clinical research; dental implants; dental prosthesis; eating; functional ability; human subject; human therapy evaluation; longitudinal human study; medical implant science; medical rehabilitation related tag; neoplasm /cancer surgery; nutrition related tag; oral pharyngeal neoplasm; outcomes research; questionnaires; satisfaction; speech

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.

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、耗时的外科重建手术， 接受治疗前的种植体支持的牙科修复体 口腔癌患者的选择方式。 调查人员概述了一个 纵向研究，以测试三个假设：（1）传统的牙科 修复体恢复特定的口腔功能和感知， 癌前水平;（2）种植体支持的牙科修复体恢复口腔 功能和口腔知觉到癌前手术水平;和（3） 传统的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感知。 共有62 将招募早期口腔癌患者;此外，22名患者 需要部分上颌骨切除术和40个需要部分侧切术 将入组下颌骨切除术。 下颌骨缺损 游离腓骨瓣移植重建。 经过一段时间的治疗， 植入物将被放置并允许无负荷愈合六个月。 传统的假牙将由患者制造和使用， 在植入物暴露之前，I期愈合期间至少16周， 子弹上膛了 第二阶段手术后几周，患者将接受 种植体支持的假牙。 一个完整的口腔功能系列 测试和问卷将在四个时间间隔进行：（1） 消融手术前;（2）插入常规 义齿修复;（3）常规义齿修复后16周 植入后16周 插入。 所有患者将每6个月随访一次，持续12-36个月。 个月，使用寿命表分析确定植入成功率。