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临床试验/CTRI/2024/07/070714
CTRI/2024/07/070714尚未招募不适用

Study of the prevalence of bronchial asthma among patients with periodontitis: a prospective observational study

Dr Prashanth Varkey1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2024年7月29日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
400
试验地点
1
主要终点
1)Prevalence of bronchial asthma in periodontitis patients.2)Association between severity of periodontitis and bronchial asthma

研究概览

简要总结

The study employs a prospective observational design to investigate the relationship between periodontitis and bronchial asthma. This study aims to understand bronchial asthma’s prevalence and severity among periodontitis patients, shedding light on their complex relationship and influencing factors. The study population consists of 400 outpatients, aged 18-50 recruited from the Department of Periodontics and Implantology at KLE Society s Institute of Dental Sciences,  Banglore, diagnosed with periodontitis as per the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. Participants meeting the inclusion criteria will undergo clinical assessments for periodontitis severity and will be classified into 2 groups, patients with history of asthma and without history of asthma according to the spirometry values and medical history. Periodontal parameters including plaque index, gingival index, probing pocket depth, and clinical attachment loss will be evaluated by a periodontist. Immunological (IL-6,TNF- alpha, NF- kappa B) and microbiological parameters(Porphyromonas gingivalis, Treponema denticola, Tanerella forsythia) will be assessed using Multiplex RT-PCR test kits. Lung function tests will categorize bronchial asthma severity. Forced expiratory volume in one second (FEV1), forced vital capacity (FVC), FEV1/FVC will be calculated for all participants. The FEV1 values greater  than 80%, 80-60%, and less than 60% are considered mild, moderate, and severe, respectively. Lung function test along with medical history will provide comprehensive data on respiratory health. At the beginning of the test, the participants’ demographic data will be recorded. The study duration is projected to last for 6 months..

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • Individuals diagnosed with varying stages of periodontitis according to the 2017 classification of Periodontal and Peri-Implant Diseases and Conditions.
  • Documented history of bronchial asthma 3)Individuals willing to provide informed consent.

排除标准

  • Individuals with any medical conditions or history including smoking, nonsteroidal anti-inflammatory drugs (NSAIDs) use in the past three months, diabetes mellitus, collagen vascular diseases, rheumatic diseases, epilepsy and seizures, cardiovascular diseases, hypertension, thyroid disease, hyperlipidemia, chronic renal failure, liver cirrhosis, hematologic disorders, malignancy, and endocrine diseases.
  • Individuals wearing partial or complete dentures 3)Those with opium addiction or drug abuse.

结局指标

主要结局

1)Prevalence of bronchial asthma in periodontitis patients.2)Association between severity of periodontitis and bronchial asthma

时间窗: Baseline- upon enrollment

次要结局

  • 1)evaluate immunological biomarkers that may contribute to the relationship between periodontitis and bronchial asthma.2)Identify periodontal pathogens significantly associated with bronchial asthma(Baseline- upon enrollment)

研究者

发起方
Dr Prashanth Varkey
申办方类型
Other [Healthcare and Neutraceutical company]
责任方
Principal Investigator
主要研究者

Dr Sphoorthi Anup Belludi

KLE Societys Institute of Dental Sciences

研究点 (1)

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