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临床试验/CTRI/2023/07/054960
CTRI/2023/07/054960尚未招募不适用

Effects of Periodontal Therapy on Biomarker Levels of TNF-α, hsCRP & IL-1β and Clinical Outcome in Patients with COPD & Severe Chronic Periodontitis

Self1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年1月8日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
Self
入组人数
60
试验地点
1
主要终点
The expected outcomes after periodontal therapy in COPD patients are as following:

研究概览

简要总结

All the eligible subjects based on inclusion and exclusion criteria consenting for study will be included and will be allocated randomly to one of the groups on the basis of CAL.

Information related to demographic variables including age, gender, education, income, history of smoke- and smokeless tobacco use, time since cessation of smoking, brushing habit, alcohol consumption and history of past dental treatment will be considered.

A thorough medical history of any chronic or systemic disease will be taken.

Periodontal examination

All the selected subjects will be examined in a standardized way for assessment of periodontal status by recording following clinical parameters at baseline and after one year at Department of Periodontics, Maulana Azad Institute of Dental Sciences, New Delhi:

•Full Mouth Bleeding score (Ainamo & Bay 1975)19

•Probing pocket depth: will be assessed by using UNC-15 periodontal probe (University of North Carolina-15) from the gingival margin to the bottom of periodontal sulcus or pocket.

•Clinical attachment level by detecting the CEJ using periodontal probe.

Periodontal Therapy

It comprises of oral hygiene instructions and appropriate periodontal therapy for test group patients and follow ups will be done at 3,6,9,12 months.

Biomarker levels of TNF-α, hsCRP & IL-1β

Peripheral venous blood will be collected from the patients in test and control group at baseline and at the end of one year for the evaluation of biomarker levels of TNF-α, hsCRP & IL-1β.

Assessment of quality of life by using SGRQ questionnaire

Quality of life will be assessed by using standardized St. George’s Respiratory Questionnaire in both the groups at baseline and after one year at Department of pulmonary medicine, Lok Nayak Hospital, New Delhi.

Lung functions

Spirometry will be done at Department of Pulmonary Medicine, Lok Nayak Hospital, New Delhi for each patient in both the group at baseline and at the end of one year by a trained professional. FEV1, FCV & FEV1/FCV will be calculated for the categorization of COPD patients according to GOLD criteria.

Acute exacerbation in COPD & Number of hospitalization

A moderate exacerbation is defined as sustained worsening of baseline respiratory symptoms for >2 days that required oral corticosteroids and antibiotics prescribed by physician. Severe exacerbation is defined by the requirement for hospitalization. Data for the exacerbation and number of hospitalization will be collected for 12 months during the quarterly visits, and any additional visit referral.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
40.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • oPatients of either sex above 40 years of age oPatients having ≥ 20 natural teeth oPatients with CAL 5mm oFull Mouth Bleeding score (FMBS)30%.

排除标准

  • oPatients with history of periodontal treatment in last 6 months.
  • oPatients under long-term antibiotics known to influence periodontal health.
  • oPatients with chronic systemic inflammatory disease.
  • oPatients with worsening of respiratory symptoms and expected survival of less than 2 years.
  • oInability to provide information or to cooperate with the dental examinations.
  • oPatients with any co-morbidity affecting periodontal health.
  • oPregnant and lactating patients.
  • oPatients unable to perform lung function test.

结局指标

主要结局

The expected outcomes after periodontal therapy in COPD patients are as following:

时间窗: The outcomes will be assessed at the end of first year

oDecrease in frequency of acute exacerbation and number of hospitalization in COPD patients after periodontal therapy.

时间窗: The outcomes will be assessed at the end of first year

oImproved quality of life after periodontal therapy.

时间窗: The outcomes will be assessed at the end of first year

oImproved lung functions after periodontal therapy.

时间窗: The outcomes will be assessed at the end of first year

oSignificant change in biomarker levels of TNF-α, hsCRP & IL-1β in COPD patients after periodontal therapy.

时间窗: The outcomes will be assessed at the end of first year

次要结局

未报告次要终点

研究者

发起方
Self
申办方类型
Other [Self ]

研究点 (1)

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