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临床试验/NCT06126536
NCT06126536已完成不适用

Transcrestal Sinus Lift Using Osseodensification Versus Lateral Window Technique With Simultaneous Implant Placement

Al-Azhar University1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2019年12月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
14
试验地点
1
主要终点
Bone height gain

研究概览

简要总结

The aim of this study is to evaluate the transcrestal sinus lift using Osseodensification versus lateral window technique with simultaneous implant placement.

详细描述

In Group 1, crestal maxillary sinus floor elevation will be done using Osseodensification. An incision will be made near the palate, and a conservative flap will be elevated. Osseodensification burs will be used to create an osteotomy and elevate the sinus membrane gradually. The osteotomy will be filled with bone graft, and the implant will be inserted.

In Group 2, lateral maxillary sinus floor elevation will be performed by creating a bony window in the lateral wall of the sinus. The sinus floor will be carefully elevated using sinus elevation curettes. If there's a membrane perforation, a collagen membrane will be applied. Bone substitute material will be packed into the sinus, and a resorbable membrane will be placed over the window before suturing.

Both groups will use Nanobone as the graft material.

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
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Patient with residual bone height from 4-6 mm and bone quality is D3 or D
  • •Patients had to require implant treatment in the posterior maxilla.
  • •All patients will sign a consent form before the study.

排除标准

  • •1- Sinus pathology that precludes routine sinus augmentation.
  • •All contraindications of dental implants.11,12
  • •Heavy smokers.

研究组 & 干预措施

Group 1: Crestal Maxillary Sinus Floor Elevation using Osseodensification:

Experimental

A crestal incision will be made towards the palate for better wound closure. A conservative flap will be raised, extending beyond the alveolar crest to minimize complications. In cases with 4-6mm ridge height and a need for 3mm vertical depth, a narrow densifying bur will be used, followed by wider burs to elevate the sinus membrane. The Densah® Bur will compact graft material to lift the membrane without penetrating the sinus floor. The osteotomy will be filled with bone graft substitute, and the final bur will apically propel the graft for vertical augmentation. Implant placement follows confirmation via radiography.

干预措施: Crestal Maxillary Sinus Floor Elevation using Osseodensification (Procedure)

Group 2: Lateral Maxillary Sinus Floor Elevation

Experimental

In the Lateral technique, a crestal incision and mucoperiosteal flap will expose the sinus's lateral wall. A bony window is created, and when removable, sinus elevation curettes are used to elevate the sinus floor cautiously. Membrane perforations are covered with a resorbable collagen membrane if needed. Implant osteotomies follow standard protocol.

Graft material mixed with saline is gently packed into the sinus to achieve the desired bone height. A resorbable membrane is placed on the window's outer surface, and the flap is sutured for primary closure.

干预措施: Lateral Maxillary Sinus Floor Elevation (Procedure)

结局指标

主要结局

Bone height gain

时间窗: Immediate post-operative, 6 Months post-operative

In Millimeter(mm)

次要结局

  • Bone Density(Immediate post-operative, 6 Months post-operative)
  • Ridge height(Immediate post-operative, 6 Months post-operative)
  • Implant stability(Immediate post-operative, 6 Months post-operative)

研究者

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

Mohammed Elsaid

Assistant Lecturer of Oral and Maxillofacial Surgery

Al-Azhar University

研究点 (1)

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