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临床试验/NCT04192851
NCT04192851已完成不适用

Evaluation of "Tent-Pole" Grafting Technique for Reconstruction of Mandibular Ridge Vertical Defects (Clinical and Radiographic Study)

Nourhan M.Aly2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2019年1月20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
12
试验地点
2
主要终点
Radiographic Evaluation for Bone Density using Cone Beam CT

研究概览

简要总结

The aim of this study is to evaluate clinically and radio-graphically the efficiency of "Tent- Pole "grafting technique for reconstruction of anterior or posterior mandibular ridge defects using synthetic bone graft and Platelet Rich Fibrin (PRF) membrane.

详细描述

Various techniques have been described for the reconstruction of large vertical defects before implant placement . In this study we assessed the efficacy of tenting the periosteum and soft tissue matrix with titanium screws maintaining a space for the graft material in order to augment large vertical defects of mandibular ridge (anterior or posterior region) using data from 12 patients . After 6 months we assessed the increase in bone height and density.

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
40 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with missing lower tooth or teeth and have a related large vertical bony defect .
  • Patients with about 7mm residual bone hight and requiring about 5 mm increase in the vertical height of the mandibular alveolar ridge for future prosthetic rehabilitation.
  • Patients with an acceptable oral hygiene and willing to improve it

排除标准

  • Presence of infection or local lesions.
  • Parafunctional habits.
  • Current chemotherapy or radiotherapy.
  • Heavy smokers.
  • Alcohol or drug abuse.
  • Medically compromised patients with diseases that affect passively the clinical procedure or result.

结局指标

主要结局

Radiographic Evaluation for Bone Density using Cone Beam CT

时间窗: 6 months

A Cone Beam Computerized Tomography was obtained to assess the gained bone height \&density.

Pain assessment using Visual Analogue Scale

时间窗: 2 weeks

Pain was assessed through on a 10-point Visual Analogue Scale (VAS). (0-1= None, 2-4= Mild, 5-7= Moderate, 8-10= Severe)

Postoperative edema

时间窗: 2 weeks

Edema was evaluated by its ability to pit.The examiner fingers pressed into dependent area of the patient skin for 5 seconds. The finger sinks into the tissue and leave an impression when they are removed. The pitting was graded on a scale of +1 to +4 as follows: * 1 (trace) slight indentation rapid return to normal. * 2 (mild) the indentation returns to normal in a few seconds. * 3 (moderate) 6 mm indentation rebounds in 10-20 seconds. * 4 (severe) 8 mm indentation rebounds in more than 30 seconds.

次要结局

未报告次要终点

研究者

发起方
Nourhan M.Aly
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Nourhan M.Aly

Instructor of Dental Public Health

University of Alexandria

研究点 (2)

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