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临床试验/NCT06180187
NCT06180187尚未招募不适用

Radiographic and Clinical Comparative Study Between Osseodensification Burs and Electrical Mallet in Closed Sinus Floor Elevation and Simultaneous Implant Placement. Prospective Clinical Trial.

Fayoum University0 个研究点目标入组 50 人开始时间: 2023年12月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
50
主要终点
change in bone density

研究概览

简要总结

The aim of the comparative study is to evaluate the density and amount of new bone formed (bone height gain)around dental implant placed simultaneously in posterior maxilla after closed sinus floor elevation using Osseodensification burs versus electrical mallet.

详细描述

Extraction of posterior teeth in the maxilla for long time without rehabilitation of the area increases the incidence of maxillary sinus pneumatization that makes maxillary sinus enlarges in volume over the residual bone of alveolar ridge.

Decreasing the height of sub_ antral bone affects adversely on the bone density which is crucial for implant primary stability causing placement of dental implant quite challenging requiring sinus lifting procedure and bone condensation of residual ridge in addition to bone grafting

Summers technique considered the gold standard for closed sinus floor elevation using osteotome and a hand mallet to condense alveolar bone and elevate schneiderian membrane. One of drawbacks of this technique is benign paroxysmal positional vertigo due to force applied by hand mallet is not controlled.

Electrical mallet was introduced to overcome (BPPV) as it applies controlled force (daN) in short fraction of seconds(µs) with hand piece secured totally by the surgeon and have a wide variety of instruments placed on the hand piece e.g. osteotomes used in sinus floor elevation .

Controlled force of magnetic mallet decrees the risk of schneiderian membrane perforation

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
Single (Outcomes Assessor)

入排标准

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

入选标准

  • patients with partially edentulous posterior maxilla
  • Residual bone height ≥ 5mm
  • Oral hygiene : fair oral hygiene

排除标准

  • Systematic disease that affects bone remodeling (e.g. uncontrolled Diabetes mellitus or osteoporosis)
  • Radiotherapy to head and neck or chemotherapy
  • Chronic disease of maxillary sinus

结局指标

主要结局

change in bone density

时间窗: 6 months follow up

Evaluate the amount of change in bone density around dental implant immediately post operative and after 6 months.

bone height gain

时间窗: 6 months follow up

Evaluate the change in bone height radiographically after closed sinus floor elevation and simultaneous implant placement .using cone beam computed tomography immediate after surgery and 6 months post operative .

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

Abdelrahman sayed mostafa elsayed

Dentist

Fayoum University

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