Effects of Periodontal Therapy on Various Clinical Outcome in Patients with COPD & Severe Chronic Periodontitis

Not yet recruiting

• Conditions: Chronic obstructive pulmonary disease, unspecified,

• Registration Number: CTRI/2023/07/054960
• Lead Sponsor: Self

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-08
• Last Update Posted: 2023-06-23

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

Exclusion Criteria

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The expected outcomes after periodontal therapy in COPD patients are as following:	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.	The outcomes will be assessed at the end of first year
oImproved quality of life after periodontal therapy.	The outcomes will be assessed at the end of first year
oImproved lung functions after periodontal therapy.	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.	The outcomes will be assessed at the end of first year

Trial Locations

Locations (1)

Maulana Azad institute of dental sciences New Delhi; 🇮🇳 Delhi, DELHI, India

Maulana Azad institute of dental sciences New Delhi

🇮🇳Delhi, DELHI, India

Dr Deepmala Maurya

Principal investigator

9654700957

deepmalamaids@gmail.com