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临床试验/NCT03156569
NCT03156569已完成不适用

Oral Health and Salivary Markers in Patients With Xerostomia

Universidad de Murcia1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2016年1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
Interleukins

研究概览

简要总结

The purpose of this study was to investigate the salivary levels of inflammatory and their association with oral health in xerostomía patient

详细描述

Primary Outcome Measures:

  • salivary Proinflammatory and anti-inflammatory cytokines
  • questionnaire is provided to the patient for xerostomia characterization

Secondary Outcome Measures:

  • Probing pocket depth
  • Probing pocket depth and clinical attachment level
  • Gingival index
  • Plaque index
  • Bleeding on probing

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • The patient must have clinical symptoms of xerostomia (dry mouth)

排除标准

  • Head and neck radiotherapy
  • Administration anti-inflammatory drugs or antibiotic therapies within the previous 6 months
  • Patients who are unable or unwilling to cooperate
  • Patient suffering from cancer

结局指标

主要结局

Interleukins

时间窗: 2 months

Analytes in saliva IFN-(pg/ml), IL-10(pg/ml), IL-1b(pg/ml), IL-4 (pg/ml)and IL-6 (pg/ml)

saliva flow rate

时间窗: 2 months

Unstimulated salivary flow rate. Pathological \< or 1.5 ml/ 15 minutes.

Xerostomia

时间窗: 2 months

Visual Analogue Scale (VAS) for xerostomia severity (0 cm: no xerostomía , 10cm : very severe xerostomia ).

次要结局

  • Oral Exam(4 months)
  • Periodontal evaluation(4 months)

研究者

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

Pia Lopez Jornet

MD DDS PhD

Universidad de Murcia

研究点 (1)

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