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临床试验/NCT02661139
NCT02661139招募中不适用

Prospective Registry of Prosthodontic Rehabilitation in Oncology Patients Undergoing Jaw Reconstruction

AZ Sint-Jan AV1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2013年6月最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
55
试验地点
1
主要终点
prosthesis survival rate

研究概览

简要总结

The investigators aim to develop a prospective database in which patient demographics, surgical, dental, prosthetic and QOL parameters collected during consecutive visits within the framework of routine practice, are being registered for each oncological patient eligible for (immediate/delayed) fixed prosthodontic rehabilitation at time of oral cavity reconstruction

详细描述

The number of patients requiring major ablative surgery in the oral cavity, including partial/radical mandibular or maxillary resection, due to a head and neck carcinoma, osteoradionecrosis (ORN), or medication-related osteonecrosis of the jaw (MRONJ) has not been accurately reported. Surgical reconstruction to restore oral function and aesthetics forms a challenge to maxillofacial surgeons, and greatly impacts patient' quality of life (QOL). Recently, an active collaboration between the surgeons of the Oral and Maxillofacial Surgery Unit and the prosthodontist (LB) of the Department of Dentistry at the General Hospital Saint-John Bruges led to the development of the "Oncology-bridge (O-bridge)" protocol, which offers (immediate/delayed) fixed prosthetic rehabilitation in a minimum of sessions and a strongly reduced two-week treatment time, consequently accelerating patient' improved QOL at a considerably reduced cost.

The investigators aim to develop a prospective database in which patient demographics, surgical, dental, prosthetic and QOL parameters collected during consecutive visits within the framework of routine practice, are being registered for each oncological patient eligible for (immediate/delayed) fixed prosthodontic rehabilitation at time of oral cavity reconstruction This could provide the investigators with more information about potential patient, surgical and prosthetic factors influencing short- and long-term biological and mechanical stability, as well as patient QOL. Moreover, registration of those results could function as a measurement of quality of care, and could be used for sample size calculation for future large prospective trials.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients of all ages
  • Patients of all genders
  • Patients with a histologically or clinically confirmed diagnosis of ORN, MRONJ, as classified by Ruggiero et al. (Ruggiero, et al., 2014) or carcinoma located in the oral cavity and jawbone, requiring segmental or total jaw resection
  • Patients eligible for jaw and oral cavity reconstruction combined with immediate/delayed implant loading for fixed prosthetic rehabilitation
  • Patients not eligible for conventional removable prosthetic rehabilitation

排除标准

  • Patients with a clinically confirmed diagnosis of osteonecrosis not related to an oncological diagnosis or treatment
  • Patients with medical contraindications for jaw reconstruction combined with immediate implant loading for fixed prosthetic rehabilitation
  • Patients eligible for conventional removable prosthetic rehabilitation

结局指标

主要结局

prosthesis survival rate

时间窗: within 60 months postoperative

implant survival rate

时间窗: within 60 months postoperative

bone resorption, as evaluated with cone-beam computed tomography

时间窗: within 60 months postoperative

次要结局

  • Prevalence of oncological patients requiring jaw reconstruction secondary to tumour resection, ORN or MRONJ(within 12 months postoperative)
  • Potential biologic or mechanical risk factors predictive of undesirable functional or aesthetic outcomes, through regression analysis(within 60 months postoperative)
  • Patient' quality of life after prosthetic rehabilitation(until a maximum of 60 months follow-up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Johan Abeloos

Maxillofacial surgeon, Head of Department

AZ Sint-Jan AV

研究点 (1)

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