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临床试验/NCT04791436
NCT04791436招募中不适用

Oral and Olfactory Complications of Recovered COVID-19 Patients: A Prospective Cohort Study

University of Giessen1 个研究点 分布在 1 个国家目标入组 402 人开始时间: 2021年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
402
试验地点
1
主要终点
Oral mucocutaneous lesions

研究概览

简要总结

This cohort study aims to investigate the long-standing chemosensory disorders and oral manifestation after recovery of the COVID-19 illness. A correlation between the long-standing symptoms and the COVID-19 severity grade will be very important to understand and clarify the aetiology of these symptoms.

详细描述

This prospective cohort study aims to investigate the long-standing chemosensory disorders and oral manifestation after recovery of the COVID-19 illness. A correlation between the long-standing symptoms and the COVID-19 severity grade will be very important to understand and clarify the aetiology of these symptoms.

Study objectives:

  1. To describe the frequency and severity of oral signs and chemosensory disorders that persist after the recovery of COVID-19 and to examine whether "taste disorders" can be discriminated into an- or hypogeusia and an- or hyposmia.
  2. To report any correlation between the severity grade of COVID-19 and the resulting standing symptoms.
  3. To describe the oral microbiome after infection with COVID-19 and to describe possible changes in comparison to normal healthy individuals.

Clinical and -if indicated- radiological examination to assess the long-term oral and chemosensory impairment and complaints of COVID-19 patients after their recovery shall be performed in an interdisciplinary setting of Maxillofacial Surgery, ENT and Medical Microbiology.

The study subjects will be divided into three groups according to the severity grade of illness: non-hospitalized, hospitalized, and intensive care patients. All adult COVID-19 recovery patients (exceeding the age of 18) will be included in the study. The time between illness and study recruitment shall be at least 3 months. Exclusion criteria are psychiatric or neurological diseases, previous trauma, surgery or radiotherapy in the oral or nasal cavities, pre-existing taste or smell dysfunctions or chronic rhinosinusitis.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • All adult COVID-19 recovery patients (exceeding the age of 18) will be included in the study. The time between illness and study recruitment shall be at least 3 months.

排除标准

  • Exclusion criteria are psychiatric or neurological diseases, previous trauma, surgery or radiotherapy in the oral or nasal cavities, pre-existing taste or smell dysfunctions or chronic rhinosinusitis.

结局指标

主要结局

Oral mucocutaneous lesions

时间窗: At least 3 months after recovery of COVID-19

An intraoral examination will be carried out to assess the presence of any mucocutaneous lesions (dichotomous variable)

Periodontal health

时间窗: At least 3 months after recovery of COVID-19

Community Periodontal Index (CPI) of the World Health Organization (WHO) will be used to assess periodontal health (continuous variable)

Gustatory function

时间窗: At least 3 months after recovery of COVID-19

Burghart Sniffin' Sticks "Screening 12 Test" will be used to assess gustatory function (continuous variable)

Olfactory function

时间窗: At least 3 months after recovery of COVID-19

Burghart Sniffin' Sticks "Screening 12 Test" will be used to assess olfactory function (continuous variable)

次要结局

未报告次要终点

研究者

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

Sameh Attia

Head of the Dental Polyclinic

University of Giessen

研究点 (1)

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