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临床试验/NCT04625192
NCT04625192Unknown不适用

Lateral Sinus Lift Technique Using Trephine Osteotomy With Simultaneous Implant Placement (Clinical Trial)

Hams Hamed Abdelrahman1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2020年2月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
14
试验地点
1
主要终点
change in bone vertical bone height

研究概览

简要总结

Trephine osteotomy was used for lateral sinus lifting technique associated with sinus floor augmentation using the autogenous bone resulting from implant drilling using specialized trephine drills.

详细描述

The study includes 14 patients in whom the lateral sinus lift technique was performed using the trephine osteotomy with simultaneous implant placement.

Sinus floor augmentation with autogenous bone graft resulting from implant site preparation with trephine drills.

Implant stability and rate of complications such as Schneiderian membrane perforation and bleeding will be assessed.

Patients will also provide their subjective assessment of postoperative pain and swelling. Vertical bone height, that will be gained, will be assessed radiographically

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients of both genders requiring implant placement in the posterior maxilla.
  • Age between 20-50 years.
  • Tooth extractions at the implant sites were performed at least 4 months before surgery.
  • Residual bone height between the alveolar bone crest and the sinus floor ranges from 4 to 6 mm.
  • Patients who are willing and fully capable to comply with the study protocol

排除标准

  • Maxillary sinus pathologies (sinusitis, long standing nasal obstruction)
  • Any disease contraindicating surgery (e.g. uncontrolled diabetes)
  • Heavy smokers
  • Acute oral infections
  • Poor oral hygiene
  • A history of radiotherapy or chemotherapy of the head and neck region

结局指标

主要结局

change in bone vertical bone height

时间窗: at baseline, 3rd and 6th months

Panoramic radiography will be performed immediately postoperatively and cone beam computed tomography (CBCT)

Change in Implant stability

时间窗: at baseline and 6 months

This will be measured by implant stability meter (OsstellTM)

change in bone density

时间窗: at baseline, 3rd and 6th months

Panoramic radiography will be performed immediately postoperatively and cone beam computed tomography (CBCT)

change in bone volume

时间窗: at baseline, 3rd and 6th months

Panoramic radiography will be performed immediately postoperatively and cone beam computed tomography (CBCT)

次要结局

  • Postoperative edema(after 1 week)
  • post operative pain(after 1 week)

研究者

发起方
Hams Hamed Abdelrahman
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Hams Hamed Abdelrahman

Assistant lecturer of DPH and Clinical statistician

Alexandria University

研究点 (1)

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