Evaluation of Oral Health Status and Cytokine Levels in Sars-Cov-2 Hospitalized Patients: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 320
- 试验地点
- 8
- 主要终点
- Dental Plaque Status - GI
研究概览
简要总结
Two hundred individuals will be formed according to the study and control groups: Group-1: coronavirus 2 (Covid-19) (+) patients (n=100) and Group-2: Healthy individuals (in which the volunteers will be included due to group-1) (n=100). Oral examinations including DMFT scores, salivary flow rate, visible gingival index scores and radiographs (OPG) will be performed on both groups on the 1st appointment. Oral swap samples will be collected with sterile swap brushes (Six sample for each person) on the 1st, 7th and 30th days to evaluate the salivary immunoglobulins (Immunoglobulin A (IgA), Immunoglobulin G (IgG), Immunoglobulin M (IgM)) and cytokine (IL-1, IL-6, IL-10) levels. Blood samples will be collected to validate the oral swap test results.
详细描述
Severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2) is the virus responsible for coronavirus disease 2019 (COVID-19) which also affects all systems of the body including the oral environment. Recent studies have demonstrated the association between oral health status and systemic diseases. including systemic infections and respiratory diseases. Aim of this study is to analyze the immunoglobulin and cytokine levels of SARS-CoV-2 patients and correlate the oral health status of these patients. Our hypotheses are, 1) Covid-19 affects individuals with low oral hygiene (high DMFT score) more severely, 2) Oral cytokine levels will increase similarly to blood levels in patients with Covid-19, 3) Oral immunoglobulin levels in patients with Covid-19 decreased similarly to those in blood. Oral examination of 100 Covid (+) patients which were hospitalized due to acute respiratory failure will be performed in the dental department of each faculty hospital. Decay-Missing-Filled Tooth (DMFT) scores, visible gingival plaque index (Löe-Silness), Bleeding on Probing (BoP) scores, and orthopantomographs (OPG) will be collected for each participant. Oral swap specimens will be collected (6 sample for each person) to evaluate the levels of salivary immunoglobulins (IgA, IgG, IgM) and cytokines (IL-1, IL-6, IL-10) on 1st, 7th, and 30th days. ELISA test will be performed for immunological analysis with ready-made kits (SunRed Biotech. Co, Shanghai, China). Full blood analyses will be performed to validate and correlate the actual cytokine and immunoglobulin levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
Care provider, investigator and outcome assessors are chosen from separate specialists (Intensive Care Unit, Dentistry, Infectious Disease Departments).
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
- 是
入选标准
- •Covid (+) patients,
- •Patients who were hospitalized due to Acute Respiratory Deficiency,
- •Conscious patients in ICU (intensive care unit) or IDMC (Infectious Diseases and Microbiology Clinic).
排除标准
- •Patients with Cancer,
- •Patients with Autoimmune System diseases,
- •Pregnant women,
- •Patients with Immune Deficiency diseases (Acquired immune deficiency syndrome - AIDS, Autoimmune lymphoproliferative syndrome - ALPS , Chronic granulomatous disease - CGD, etc.).
结局指标
主要结局
Dental Plaque Status - GI
时间窗: Baseline (1st appointment), 7th day (2nd appointment), 30th day (3rd appointment)
Gingival Index scores (visible dental plaque) will be evaluated for both study groups.
DMF Index
时间窗: Baseline (1st appointment)
Decay, Missing, Filled teeth scores will be recorded and evaluated for both study groups.
Salivary Flow Rate
时间窗: Baseline (1st appointment), 7th day (2nd appointment), 30th day (3rd appointment)
Salivary flow rate of each participant is calculated by measuring the unstimulated saliva volume (ml/min).
Periodontal Bleeding Status - BoP
时间窗: Baseline (1st appointment), 7th day (2nd appointment), 30th day (3rd appointment)
Bleeding volume (ml/sec) on probing will be evaluated for both study groups.
Oral Cytokine Levels
时间窗: Baseline (1st appointment), 7th day (2nd appointment), 30th day (3rd appointment)
Oral cytokine levels will be evaluated for both study groups three times, due to the half-life of specific markers (IL-1, IL-6, IL-10).
Oral Immunoglobulin Levels
时间窗: Baseline (1st appointment), 7th day (2nd appointment), 30th day (3rd appointment)
and immunoglobulin levels will be evaluated for both study groups three times, due to the half-life of specific markers (IgA, IgG, IgM).
次要结局
- Systemical Diseases(Baseline (1st appointment))
- Age Range of the Participants(Baseline (1st appointment))
- Gender Distribution(Baseline (1st appointment))
研究者
Cem Peskersoy
Assisstant Professor
Ege University