| CTRI Number |
CTRI/2023/07/054960 [Registered on: 07/07/2023] Trial Registered Prospectively |
| Last Modified On: |
23/06/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effects of Periodontal Therapy on Various Clinical Outcome in Patients with COPD & Severe Chronic Periodontitis |
|
Scientific Title of Study
|
Effects of Periodontal Therapy on Biomarker Levels of TNF-α, hsCRP & IL-1β and Clinical Outcome in Patients with COPD & Severe Chronic Periodontitis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Deepmala Maurya |
| Designation |
Lecturer |
| Affiliation |
Maulana Azad institute of dental sciences New Delhi |
| Address |
Department of periodontics, Maulana Azad institute of dental sciences, New Delhi
Central
DELHI
110002
India |
| Phone |
|
| Fax |
|
| Email |
deepmalamaids@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepmala Maurya |
| Designation |
Lecturer |
| Affiliation |
Maulana Azad institute of dental sciences New Delhi |
| Address |
Department of periodontics, Maulana Azad institute of dental sciences, New Delhi
DELHI
110002
India |
| Phone |
|
| Fax |
|
| Email |
deepmalamaids@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepmala Maurya |
| Designation |
Lecturer |
| Affiliation |
Maulana Azad institute of dental sciences New Delhi |
| Address |
Department of periodontics, Maulana Azad institute of dental sciences, New Delhi
DELHI
110002
India |
| Phone |
|
| Fax |
|
| Email |
deepmalamaids@gmail.com |
|
|
Source of Monetary or Material Support
|
| The study will be carried out at Lok Nayak Hospital and Maulana Azad institute of dental sciences New Delhi and infrastructure will be provided by the institute for the study |
|
|
Primary Sponsor
|
| Name |
Self |
| Address |
Self |
| Type of Sponsor |
Other [Self ] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Deepmala Maurya |
Maulana Azad institute of dental sciences New Delhi |
Maulana Azad institute of dental sciences New Delhi India
New Delhi
DELHI |
9654700957
deepmalamaids@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J449||Chronic obstructive pulmonary disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Biomarker levels of TNF-α, hsCRP & IL-1β
Assessment of quality of life by using SGRQ questionnaire
Lung function tests
Acute exacerbation in COPD & Number of hospitalization |
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.
|
| Intervention |
Comparison of various parameters following periodontal therapy in COPD patients |
The proposed study will evaluate the periodontal status and effects of periodontal therapy on clinical outcomes in COPD patients including frequency of acute exacerbation, biomarker levels of TNF-α, hsCRP & IL-1β, quality of life, number of hospitalization and lung functions. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
o Patients of either sex above 40 years of age
o Patients having ≥ 20 natural teeth
o Patients with CAL 5mm
o Full Mouth Bleeding score (FMBS)30%.
|
|
| ExclusionCriteria |
| Details |
o Patients with history of periodontal treatment in last 6 months.
o Patients under long-term antibiotics known to influence periodontal health.
o Patients with chronic systemic inflammatory disease.
o Patients with worsening of respiratory symptoms and expected survival of less than 2 years.
o Inability to provide information or to cooperate with the dental examinations.
o Patients with any co-morbidity affecting periodontal health.
o Pregnant and lactating patients.
o Patients unable to perform lung function test.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
The expected outcomes after periodontal therapy in COPD patients are as following:
o Decrease in frequency of acute exacerbation and number of hospitalization in COPD patients after periodontal therapy.
o Significant change in biomarker levels of TNF-α, hsCRP & IL-1β in COPD patients after periodontal therapy.
o Improved quality of life after periodontal therapy.
o Improved lung functions after periodontal therapy.
|
The outcomes will be assessed at the end of first year
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/08/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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.
|