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临床试验/NCT01974401
NCT01974401已完成2 期

Effect of Using Supragingival Irrigators Containing Chlorhexidine on Oral Health in Patients With Blood Dyscrasia

Mashhad University of Medical Sciences2 个研究点 分布在 2 个国家目标入组 20 人开始时间: 2010年1月最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
20
试验地点
2
主要终点
improvement in oral health status

研究概览

简要总结

in this study , effectiveness of supragingival irrigators containing chlorhexidine is compared with routine oral health measures in patients with blood dyscrasia whom can not use effective oral health measures(e.g brushing ) due to their systemic condition(e,g,neutropenia ,thrombocytopenia,..)

详细描述

Since some patients with hematologic malignancies cannot brush effectively and are at increased risk of bleeding and infection due to severe neutropenia and thrombocytopenia we want to access whether a none invasive method ( water jet systems containing chlorhexidine ) Can help this patients to get better oral health indexes in comparison with routine oral health measures in these type of patients.

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 (Investigator)

入排标准

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

入选标准

  • patients with a blood dyscrasia, severe neutropenia and thrombocytopenia, absence of periodontitis, absence of any oral mucosal lesion in onset of study, patient consent

排除标准

  • diabetes mellitus, observation of any side effect (resulted from the device), severe oral mucositis in intervention group(grade 3 and4 WHO), edentulousness, intolerance of device in severely malaise patients, patient death

研究组 & 干预措施

water jet irrigator

Active Comparator

patients used supra-gingival irrigators as an oral health measure

干预措施: supragingival irrigators containing chlorhexidine (Device)

control group

No Intervention

patients in this group received routine oral health care protocols.

结局指标

主要结局

improvement in oral health status

时间窗: 3 weeks

improvement of oral health was measured by oral health index simplified(OHI-S)

次要结局

  • incidence of oral mucositis(3 weeks)

研究者

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

Pegah Mosannen Mozafari

assistant professor of oral medicine

Mashhad University of Medical Sciences

研究点 (2)

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