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临床试验/NCT03633968
NCT03633968Unknown不适用

Assessment of the Effect of the Antrostomy Size in Graftless Lateral Maxillary Sinus Floor Elevation Using AMBE (Antral Membrane Balloon Elevation) With Simultaneous Implant Placement

ahmed mohammed khalil aldahouk2 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2018年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
14
试验地点
2
主要终点
amount of bone formation

研究概览

简要总结

two groups undergo for graftless sinus lift using AMBE (antral membrane balloon elevation) through different antrostomy size with simultaneous implant placement

详细描述

control group undergoes for graftless sinus lift using AMBE through large antrostomy with simultaneous implant placement. While, study group undergo for graftless sinus lift using AMBE through small antrostomy with simultaneous implant placement. the aim of the study is assessment the effect of antrostomy size on bone formation in graftless sinus lift with simultaneous implant placement.

CBCT will be done before and after the surgery and after 6 months to assess of amount bone gain in mm.

implant stability after 6 months will be determined by using Osstell. Primary outcome: amount of bone gain which will be measured by using linear measurement from CBCT.

secondary outcome: stability of implant by using osstell

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Participant)

盲法说明

assessment of the effect of the antrostomy size in graftless lateral maxillary sinus floor elevation using AMBE (antral membrane balloon elevation) with simultaneous implant placement

入排标准

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

入选标准

  • Patients with atrophic maxilla and pneumatization of maxillary sinus with residual bone height from 3-6mm.
  • No intraoral soft and hard tissue pathology,
  • No systemic condition that contraindicate implant placement

排除标准

  • Sinus pathology.
  • Heavy smokers more than 20 cigarettes per day.
  • Patients with systemic disease that may affect normal healing.
  • Psychiatric problems.
  • Disorders to implant are related to history of radiation therapy to head and neck neoplasia or bone augmentation to implant site

研究组 & 干预措施

maxillary sinus lift small antrostomy

Active Comparator

local anaesthesia will be given flap will be reflected to expose sinus lateral wall. round diamond bur will be used to make small antrostomy and expose schneiderian membrane.

maxillary sinus lift by using antral membrane balloon elevation without using graft material with simultaneous implant placement

干预措施: maxillary sinus lift (Procedure)

maxillary sinus lift large antrostomy

Active Comparator

local anaesthesia will be given flap will be reflected to expose sinus lateral wall round diamond bur will be used to make large antrostomy and expose schneiderian membrane.

maxillary sinus lift by using antral membrane balloon elevation without using graft material with simultaneous implant placement

干预措施: maxillary sinus lift (Procedure)

结局指标

主要结局

amount of bone formation

时间窗: after 6 months

measurement of amount of bone gained by using CBCT

次要结局

  • implant stability(after 6 months)

研究者

发起方
ahmed mohammed khalil aldahouk
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

ahmed mohammed khalil aldahouk

Principal Investigator(doctor)

Cairo University

研究点 (2)

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