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临床试验/NCT05108324
NCT05108324Unknown不适用

Reliability of All on Four Using 2 Zygomatic and 2 Conventional Implants Versus Conventional All on Four Implants Simultaneously for the Rehabilitation of the Atrophied Maxilla (A Randomized Control Trial)

Cairo University0 个研究点目标入组 20 人开始时间: 2021年11月10日最近更新:
适应症

试验速览

阶段
不适用
入组人数
20
主要终点
change of function of the masticatory muscles

研究概览

简要总结

Oral rehabilitation by dental implants in the severely atrophic maxilla often represents a challenge. To overcome this difficulty, bone augmentation procedures such as sinus augmentation, guided bone regeneration (GBR), or distraction osteogenesis have been used to obtain adequate bone height and width for proper three-dimensional implant placement. To avoid surgical morbidity and shorten treatment length, alternative methods such as short or tilted implants, as well as zygomatic implants (ZIs),have been proposed and have shown promising outcomes.

详细描述

Placement of dental implants in the pterygo-maxillary region provides adequate posterior bone support for the prosthesis which permits better distribution of masticatory forces without the need of sinus floor augmentation, onlay and inlay grafts, split crest technique, or osteogenic distraction. This allows rehabilitating patients with satisfactory full arch fixed maxillary prosthesis, which is usually spanned from second molar to contralateral second molar tooth.

The purpose of the present study is to compare the Reliability of all on four by 2 zygomatic implants with 2 conventional implant in anterior region versus all on four approach by conventional implant for the rehabilitation of the atrophied maxilla in terms of survival rates and improving the quality of patient's life and involved complication with maxillary sinus.

研究设计

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

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with severely atrophic edentulous upper arch (Cawood class IV, V, VI) that could not be restored with other type of treatment.
  • Patients who had at least 8-12 mm vertical bone height in anterior maxilla to allow installation of at least 2 conventional implants.

排除标准

  • Patients with any systemic disease that might interfere with dental implants placement and/or osseointegration e.g. uncontrolled diabetes, hypertension and osteoporosis, etc.
  • Heavy smoker (> 20 cigarettes daily) and patients with history para-functional habits (e.g. clenching or bruxism, etc.) were also excluded.
  • Intraoral pathological lesion, related to maxilla, maxillary sinus and zygoma.

结局指标

主要结局

change of function of the masticatory muscles

时间窗: baseline & 6 month after the delivery of the prothesis

measuring muscles activtiy of masseter and temporalis muscles by electromyography

次要结局

  • Implant primary stability(baseline Immediate after implantation)

研究者

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

mostafa elmasry

principle investigator

Cairo University

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