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临床试验/NCT02507596
NCT02507596已完成不适用

Clinical and Radiographic Evaluation of Nano-crystalline Hydroxyapatite Silica Gel in the Treatment of Human Periodontal Intrabony Defects

Cairo University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2015年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Clinical attachment level

研究概览

简要总结

A clinical and radiographic evaluation of Nano-crystalline hydroxyapatite silica gel in comparison with open flap debridement for management of periodontal intrabony defects.

详细描述

Thirty patients suffering from advanced chronic periodontitis were included in this randomized controlled clinical trial. Each subject contributed matched two- or three-walled intrabony defects. Patients were equally assigned into the experimental group; Nano-crystalline hydroxyapatite silica gel or the negative control group;open flap debridement. Clinical and radiographic parameters were recorded at baseline and at 3 and 6 months postoperatively.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
35 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Severe chronic periodontitis patients.
  • having at least one site with pocket depth ≥ 6 mm and clinical attachment level ≥ 5 mm, with radiographic evidence of bone loss as detected in periapical radiographs.

排除标准

  • Pregnant women
  • Subjects had <22 permanent teeth
  • Having any given systemic disease
  • Taking any type of medication and/or antibiotic therapy during the 3 months before the study
  • Received periodontal treatment within the past 12 months Current or former smokers

结局指标

主要结局

Clinical attachment level

时间窗: change from Baseline at 6 months

Change from baseline in clinical attachment level in mm in chronic periodontitis patients at 6 month

次要结局

  • bone defect area(Baseline and 6 months)
  • pocket depth(Baseline and 6 months)

研究者

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

Noha Ayman Ghallab

Associate Professor of Oral Medicine and Periodontology

Cairo University

研究点 (1)

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