跳至主要内容
临床试验/NCT05831267
NCT05831267已完成不适用

Fibrin Glue Versus Titanium Platelet-rich Fibrin as a Sole Filling Material in Lateral Sinus Lifting With Simultaneous Implant Placement (Randomized Controlled Clinical Trial )

Hams Hamed Abdelrahman2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
2
主要终点
change in bone density

研究概览

简要总结

Graftless sinus lift with simultaneous implant placement is one of the new techniques, this new technique is presented based on the physiology of intrasinus bone repair.

Schneiderian membrane is known to have an osteogenic nature, now blood clot can be considered autologous osteogenic graft material, to which osteoprogenitors can migrate, differentiate, and regenerate bone.

The aim of this study is to evaluate the effectiveness of using Fibrin glue versus Titanium platelet rich fibrin (T-PRF) as a sole filling material in lateral sinus lifting using with simultaneous implant placement in comparison to a negative control group.

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

入选标准

  • Patients requiring implant placement in the posterior maxilla.
  • 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 is 3-5 mm

排除标准

  • Maxillary sinus pathologies (sinusitis, long-standing nasal obstruction).
  • Any disease-contraindicating surgery (e.g. uncontrolled diabetes).
  • Heavy smokers (smoke greater than or equal 25 cigarettes daily).
  • Acute oral infections.
  • Untreated periodontal disease (gingival index 2 and 3).
  • Poor oral hygiene ( Silness-Löe index (score 2-3) ).
  • A history of radiotherapy or chemotherapy of the head and neck region.
  • Pregnancy.

结局指标

主要结局

change in bone density

时间窗: Baseline and 6 months

bone density will be measured using CBCT

change in implant stability

时间窗: Baseline and 6 months

implant stability will be measures using Ostell device.

change in vertical bone height

时间窗: Baseline and 6 months

vertical bone height will be measured using CBCT

次要结局

  • change in pain intensity(Through 1 week postopertaive)
  • Change in edema score(Through 1 week postopertaive)

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 (2)

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