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临床试验/NCT02664298
NCT02664298终止不适用

Prospective Registry of Immediate/Delayed Loading of Implants in the Cranial Bone-grafted Severely Atrophic Jaw

AZ Sint-Jan AV1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2007年1月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
120
试验地点
1
主要终点
IPI survival rate at time of immediate loading in patients with cranial bone-grafted severely atrophic jaw

研究概览

简要总结

Edentulism is often associated with a negative psychosocial impact. The concept of prosthetic rehabilitation in which a prosthesis is supported by osseointegrated implants, was first introduced in the late 1960s by Brånemark et al. and offers an interesting alternative to removable prosthesis. However, for patients with a severely atrophic maxilla or mandible, cranial bone grafting of the jaw is required to increase bone width and height necessary for implant insertion. An active collaboration between the surgeons from the Oral and Maxillofacial Department and the prosthodontist from the Department of Dentistry has been established for continuous quality improvement of the concept of (immediate/delayed) implant loading in patients requiring cranial bone grafts to augment their severely atrophic jawbone.

The investigators aim to develop a prospective database registering (immediate/delayed) implant loading data of all patients eligible according to the protocol. Patient demographics, surgical, dental, prosthetic and patient satisfaction parameters are collected during consecutive visits within the framework of routine practice.

Development of a database registering immediate functional loading data secondary to cranial bone-grafting of a severely atrophic jaw, will provide more information about potential patient, surgical and prosthetic factors influencing long-term biological and mechanical stability, as well as patient satisfaction. 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 moderate to extreme bone atrophy of the jaw (class IV to VI according to Cawood and Howell (Cawood & Howell, 1988), caused by terminal periodontitis or edentulism
  • Patients requiring bone augmentation procedures through cranial bone grafting for jaw reconstruction
  • Patients ineligible for conventional removable prosthetic rehabilitation

排除标准

  • Patients not eligible according to abovementioned criteria
  • Patients with severe uncontrolled diabetes
  • Patients with cranial vault without diploe and/or cranial vault thickness <3mm, as defined with cone-beam CT (De Ceulaer, et al., 2012)

结局指标

主要结局

IPI survival rate at time of immediate loading in patients with cranial bone-grafted severely atrophic jaw

时间窗: within 6 months postsurgery

prosthesis survival rate

时间窗: until a maximum of 10 years follow-up

definitive implant survival rate in patients with cranial bone-grafted severely atrophic jaw

时间窗: within 12 months postoperative

bone-graft resorption, as evaluated through cone-beam computed tomography

时间窗: until a maximum of 10 years follow-up

次要结局

  • Prevalence of patients with severely atrophic jaw requiring cranial bone-grafting(every 12 months, until a maximum of ten years)
  • Potential biologic or mechanical risk factors that could predict undesirable functional or aesthetic outcome, through regression analysis(within 12 months postsurgery)

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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