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临床试验/NCT06360263
NCT06360263已完成不适用

OSSEODENSIFICATION BY DENSAH BURS IN COMBINATION WITH ACTIVATED PLASMA ALBUMIN GEL FOR TRANSCRESTAL MAXILLARY SINUS LIFTING WITH SIMULTANEOUS IMPLANT PLACEMENT (CLINICAL TRIAL)

Esraa Salem Kamal1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2023年7月10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
6
试验地点
1
主要终点
Implant stability

研究概览

简要总结

Aim of the current study is to evaluate clinically and radiographically transcrestal sinus lifting with densah burs with the use of activated plasma albumin gel associated with simultaneous implant placement.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

  • Patient with missing maxillary premolars and molars.
  • Vertical bone height of 3-5 mm.
  • Good oral hygiene.
  • Non smokers.

排除标准

  • Bad oral hygiene.
  • Presence of infection or periapical lesions in adjacent teeth.
  • Acute maxillary sinusitis.
  • Bruxism or clenching.
  • Medically compromised patients with a condition that affects the procedure (patients with bone diseases such as osteogenesis imperfecta and polyarthritis and patients on radiotherapy and chemotherapy)

结局指标

主要结局

Implant stability

时间窗: up to 6 months

Resonance frequency analysis is based on determining whether or not an implant is stable enough. The result is presented as an ISQ value of 1-100. The higher the ISQ, the more stable the implant.

Postoperative pain

时间窗: up to one week

This will be assessed using a 10-point Visual Analogue Scale (VAS). (0-1= None, 2-4= Mild, 5-7= Moderate, 8-10= Severe)

Vertical bone height gain

时间窗: up to 6 months

To determine the amount of bone height gain, cone beam computed tomography (CBCT) scans will be taken immediately and after 6 months. Amount of bone height gain will be measured linearly in millimeter by determine the difference between residual bone height and bone height above the implant immediately and 6 months postoperatively in anteroposterior and mediolateral dimensions.

Bone density around implant

时间窗: up to 6 months

This will be measured from CBCT scans in grayscale using a software. Densitometric analysis will be performed around dental implants on CBCT image using the software supplied with the machine. This analysis gives the actual bone density around the immersed dental implant that proves the process of osseointegration. Higher values indicate better results

次要结局

未报告次要终点

研究者

发起方
Esraa Salem Kamal
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Esraa Salem Kamal

Oral and Maxillofacial Surgery MSc Candidate

Alexandria University

研究点 (1)

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