跳至主要内容
临床试验/NCT02180932
NCT02180932已完成不适用

Towards a Viral Etiology of Periodontal Disease in Relation to Radiotherapy Treatment of Head and Neck Cancers

Centre Hospitalier Universitaire de Nice1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2014年10月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
25
试验地点
1
主要终点
Measure of level of EBV nucleic acids

研究概览

简要总结

The treatment of otolaryngology (OLR) cancer is based on surgery, radiation, sometimes used in combination with chemotherapy. Patients treated with radiotherapy have multiple oral diseases: mucositis, hyposalivation, tissue fibrosis, exacerbation of periodontitis. Over 70% of patients with head and neck cancers treated with radiotherapy have a lower level of dental clinical attachment and 92% have loose teeth or missing. The management of these oral complications is a priority in OLR oncology. The aim is to improve the oral health of patients to achieve a comfortable life acceptable and necessary for healing.

This project proposes to deepen the investigation with two main objectives:

  1. To study in vivo the effect of radiation treatment on the evolution of the viral flora of the periodontium in a cohort of patients and matched controls.
  2. To study in vitro the effects of irradiation on the replication EBV (herpesvirus) in producing websites lymphoepithelial tonsillar, and atypical dendritic cells associated with EBV that existence were recently discovered.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients ≥ 18 years
  • Patients treated with curative radiotherapy on tumor site or surgery for cancer of the oral cavity and / or oropharynx
  • Patients naive treatments for head and neck cancers
  • Patients affiliated or beneficiary of a social security scheme
  • Patients who gave informed consent in writing

排除标准

  • Patients treated with neoadjuvant chemotherapy, adjuvant or concomitant
  • Patients taking immunosuppressants after organ transplantation
  • Taking anticoagulants incompatible with dental samples (possible bleeding)
  • Patients edentulous and / or whose dental condition is incompatible with the dental samples

结局指标

主要结局

Measure of level of EBV nucleic acids

时间窗: day 180

Measure of level of EBV nucleic acids

时间窗: day 1

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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