Study of the prevalence of bronchial asthma among patients with periodontitis: a prospective observational study
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
Dr Sphoorthi Anup Belludi
KLE Societys Institute of Dental Sciences
