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临床试验/NCT01961284
NCT01961284撤回不适用

Zygomatic Versus Conventional Dental Implants in Augmented Maxillae: a Pragmatic Multicentre Randomised Clinical Trial.

NHS Lothian2 个研究点 分布在 1 个国家开始时间: 2013年10月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
发起方
NHS Lothian
试验地点
2
主要终点
Implant Success

研究概览

简要总结

Dental implants are used for replacing missing teeth. Placing dental implants is limited by the presence of adequate bone volume permitting their anchorage. In order to solve this problem several bone augmentation procedures have been developed. In principle the missing bone is taken from a donor site (for example the hip), transplanted where needed and then implants are placed. Sometimes, major bone grafting operations have to be undertaken under general anaesthesia requiring patients to be hospitalised for a few days. Some degree of morbidity related to the donor site must be expected, though more recently bone substitutes are used to minimize morbidity, and 2 to 3 surgical interventions may be needed before the implants can be functionally used. Sometimes patients have to wait more than 1 year before a prosthesis can be fixed to the implants and the total cost of the treatment is high. At the beginning of the 1990s a long screwshaped implant was developed by Professor PI Brånemark as an alternative to bone augmentation procedures: the zygomatic implant. Zygomatic implants are generally inserted through the palate to engage the body of the cheek bone. One to three zygomatic implants can be inserted through the posterior palate to engage the body of each cheek bone. The potential main advantages of zygomatic implants could be that bone grafting may not be needed and a fixed prosthesis could be fitted the same day of their placement. Despite that zygomatic implants have been used for more than 20 years, their effectiveness has never been compared with conventional dental implants in augmented maxillae. The aim of the project is to compare the longtermclinical outcome of fullarch upper jaw bridges supported by zygomatic implants versus conventional implants placed in augmented bone in the palate.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • fully edentulous patients
  • atrophic maxilla
  • insufficient bone volume for placement of dental implants
  • patients with no more than 4mm of bone height sub-antrally

排除标准

  • general contraindications to implant surgery
  • history of radiation therapy
  • immunosuppressed/immunocompromised patients
  • patients taking bisphosphonates
  • poor oral hygiene
  • patients with untreated periodontitis
  • uncontrolled diabetes
  • pregnancy
  • alcohol/drug addiction
  • lack of opposite occluding dentition/prosthesis
  • restricted mouth opening.

研究组 & 干预措施

Zygomatic Implants

Active Comparator

2-4 zygomatic implants inserted into edentulous maxilla with no augmentation/grafting prior to providing patient with dental prosthesis

干预措施: Zygomatic implant placement (Device)

Bone Graft and Conventional implants

Active Comparator

Edentulous maxilla which is deficient in bone is first grafted using bone grafting material derived from cows and then ordinary implants are placed into the augmented jaw bone approximately 6 monhts after grafting. Patients will be provided with a dental prosthesis following osseointegration.

干预措施: conventional implants and augmentation of maxilla (Device)

结局指标

主要结局

Implant Success

时间窗: 10 years after implant loading

Implant failure is defined by implant mobility +/- infection dictating implant removal

Implant success

时间窗: 15 years after implant loading

Implant failure is defined by implant mobility +/- infection dictating implant removal

次要结局

  • Change in marginal bone levels on intra oral radiographs(1,3,5,7,10,15 years)
  • Complications(15 years)
  • Failure of augmentation procedure(6 months after augmentation procedure)
  • Change in Oral Health impact profile OHIP-14(1,3,5,7,10,15)

研究者

发起方
NHS Lothian
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Victor Lopes

Professor Victor Lopes, Consultant in Oral and Maxillofacial surgery

NHS Lothian

研究点 (2)

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