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临床试验/NCT07035236
NCT07035236招募中不适用

Clinical, Radiographic and Histologic Evaluation of Tenting the Schneiderian Membrane Using Titanium Mesh for Maxillary Sinus Lift Procedure: A Randomized Controlled Study

Suez Canal University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年7月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
20
试验地点
1
主要终点
Histological evaluation of gained bone quality

研究概览

简要总结

Twenty posterior maxillary edentulous sites requiring open sinus augmentation for staged dental implant placement will be studied. Group I (study group) the maxillary sinus membrane will be elevated using titanium mesh fixed by bone screws. Group II (control group) will have stainless steel screws/pins placed bucco-palatally to maintain the elevated membrane and stabilize the formed blood clot. Platelet rich fibrin (PRF) will be placed at the site of elevated membrane in both groups.

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)

入排标准

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

入选标准

  • •Adult male/female patients with age interval 18:60 years old.
  • •Patients with one or more teeth requiring implant supported dental restoration in atrophic maxilla.
  • •Alveolar bone height less than 5 mm at the defective site.
  • •Good oral hygiene.
  • •Patient's consensual agreement to be enrolled in the study.

排除标准

  • •Medically compromised patients with conditions contraindicating surgery (eg. uncontrolled diabetics, bisphosphonate intake, radio or chemotherapy).
  • •Patients with active infection at or related to the site of surgery (eg. acute sinusitis).
  • •Heavy smokers.
  • •Patients not indicated for an implant supported restoration at the time of enrollement (eg. active/untreated periodontal disease). (Patients developing any medical condition that interferes with the outcomes after enrolment in the study will be excluded).

研究组 & 干预措施

Titanium mesh group (study group)

Experimental

Group I (study group) the Schneiderian membrane will be elevated using titanium mesh fixed by screws

干预措施: maxillary sinus lifting (Procedure)

Screws group (control group)

Active Comparator

Group II (control group) will have stainless steel screws/pins placed bucco-palatally to maintain the elevated membrane and stabilize the formed blood clot

干预措施: Maxillary sinus lifting (Procedure)

结局指标

主要结局

Histological evaluation of gained bone quality

时间窗: 6 months

Using Hematoxin and Eosin stains

Radiographic Bone gain after maxillary sinus lift

时间窗: 6 months

Using Cone Beam CT

次要结局

未报告次要终点

研究者

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

Hedra sherif

Freelance dentist

Suez Canal University

研究点 (1)

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