EFFICACY OF IMPLANT SUPPORTED MAXILLOFACIAL PROSTHESES

种植体支持的颌面假体的功效

• 批准号: 2713275
• 负责人: KRISHAN K KAPUR
• 金额: $ 36.24万
• 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/2713275
• 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; 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， 需要客观的结果评估来确定效果 昂贵且耗时的外科重建手术 种植体支持的假牙在接受治疗之前 口腔癌患者的首选治疗方式。 研究人员概述了一个 纵向研究检验三个假设：（1）传统牙科 假体恢复特定的口腔功能和感知 癌前水平； (2)种植体支持的牙修复体恢复口腔 功能和口腔感知达到癌前手术水平；和（3） 传统假牙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 62 个 将招募早期口腔癌患者；此外，还有22名患者 需要部分上颌切除术，40 需要部分侧颌切除术 将登记下颌骨切除术。 下颌骨缺损将会是 通过腓骨游离皮瓣手术重建。 经过一段康复期后， 植入物将被放置并允许在空载状态下愈合六个月。 传统的假牙将由患者制造和使用 在第一阶段愈合期间，在种植体暴露之前至少需要 16 周 已加载。 二期手术后几周，患者将接受 种植体支持的假牙。 口腔功能全系列 测试和问卷调查将每隔四个时间间隔进行：(1) 消融手术前； (2) 常规置入前一周 假牙修复体； (3)传统假牙术后16周 插入； (4) 种植体支持的假牙术后 16 周 插入。 所有患者将每隔 6 个月接受一次随访，随访时间为 12-36 月，使用生命表分析确定种植成功率。