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临床试验/NCT04686370
NCT04686370Unknown不适用

Effect of Different Implant Surface Treatments on Bony Changes Around Mandibular Implants for Completely Edentulous Patients (A Split-mouth Comparative Study)

Cairo University1 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2020年10月6日最近更新:
适应症

试验速览

阶段
不适用
入组人数
13
试验地点
1
主要终点
Marginal bone stability around dental implants

研究概览

简要总结

The research will be conducted to report which type of surface treatment of dental implants that can be successful and aids in increasing bone to implant contact and how it affects the bony changes around the implants installed in mandibular arches for completely edentulous patients or whether there are specific precautions to be taken into consideration during implant planning concerned with the type of surface microstructure treatment and recommendations needed.

详细描述

Primary objective:

PICO P: Completely edentulous patients I: Laser surface treatment of implants C: Sandblasted Acid etched surface treatment O: Bony changes

Each Participants will have 2 implants;one laser surface treated implants and another sandblasted acid-etched implant (split-mouth) installed in the intra-foraminal area of mandibular arch prosthetically driven by the prepared conventional denture. MS and AF are responsible for delayed-loading of the denture and will measure bony changes around laser treated surface implants using radiographic assessment using long paralleling technique periapical digital x-ray(SOREDEX™ DIGORA™ Optime)

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • Completely edentulous patients
  • Angle's class 1 skeletal relationship
  • Normal facial asymmetry
  • Cooperative patients
  • Adequate inter-arch spcae not less than 12mm

排除标准

  • Tempromandibular joint disorder
  • Uncontrolled diabetes
  • Bleeding disorders or anticoagulant therapy
  • Flabby tissues or sharp mandibular residual ridge
  • Heavy smoker
  • Patient's with neuromuscular disorders
  • Patients on chemotherapy or radiotherapy
  • Severe psychiatric disorders

结局指标

主要结局

Marginal bone stability around dental implants

时间窗: 1 year

Measuring amount of marginal bone loss by radiographic assessment using long paralleling technique periapical digital x-ray(SOREDEX™ DIGORA™ Optime)

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

Marwan Mohamed Abdelsalam

principal investigator

Cairo University

研究点 (1)

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