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CTRI Number  CTRI/2024/07/070714 [Registered on: 16/07/2024] Trial Registered Prospectively
Last Modified On: 15/07/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   An observational study on the link between asthma and periodontitis. 
Scientific Title of Study   Study of the prevalence of bronchial asthma among patients with periodontitis: a prospective observational study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sphoorthi Anup Belludi 
Designation  Head of the Department, Department of Periodontics 
Affiliation  KLE Societys Institute of Dental Sciences 
Address  KLE Societys Institute of Dental Sciences, 20, Yeshwanthpur Suburb, II Stage, Tumkur Road, Bangalore - 560 022

Bangalore
KARNATAKA
560022
India 
Phone  9916010380  
Fax    
Email  doc_sphoo@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sphoorthi Anup Belludi 
Designation  Head of the Department, Department of Periodontics 
Affiliation  KLE Societys Institute of Dental Sciences 
Address  KLE Societys Institute of Dental Sciences, 20, Yeshwanthpur Suburb, II Stage, Tumkur Road, Bangalore - 560 022

Bangalore
KARNATAKA
560022
India 
Phone  9916010380  
Fax    
Email  doc_sphoo@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sphoorthi Anup Belludi 
Designation  Head of the Department, Department of Periodontics 
Affiliation  KLE Societys Institute of Dental Sciences 
Address  KLE Societys Institute of Dental Sciences, 20, Yeshwanthpur Suburb, II Stage, Tumkur Road, Bangalore - 560 022

Bangalore
KARNATAKA
560022
India 
Phone  9916010380  
Fax    
Email  doc_sphoo@yahoo.com  
 
Source of Monetary or Material Support  
KLE Societys Institute of Dental Sciences,20,Yeshwanthpur Suburb,II Stage, Tumkur Road, Banglore,Karnataka, India-560022 
Zum Heilen Diagnostics and Therapeutics Pvt. Ltd. Room No. VIII 781G, Velankanni Matha Complex, Near Spices Park, Puttady P.O., Vandanmedu GP, Idukki, Kerala, India-685551 
 
Primary Sponsor  
Name  Dr Prashanth Varkey 
Address  Zum Heilen Diagnostic and Therapeutics Pvt. Ltd. Room No VIII 781G, Velankanni Matha Complex, Near Spices Park, Puttady P.O., Vandanmedu GP, Idukki District, Kerala, India-685551  
Type of Sponsor  Other [Healthcare and Neutraceutical company] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sphoorthi Anup Belludi  KLE Societys Institute of Dental Sciences  Department of Periodontics, KLE Societys Institute of Dental Sciences,20, Yeshwanthpur Suburb, II Stage, Tumkur Road, Bangalore - 560 022
Bangalore
KARNATAKA 
9916010380

doc_sphoo@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee: KLE Society s Institute of Dental Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J45||Asthma, (2) ICD-10 Condition: K05||Gingivitis and periodontal diseases,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1)Individuals diagnosed with varying stages of periodontitis according to the 2017 classification of Periodontal and Peri-Implant Diseases and Conditions.
2)Documented history of bronchial asthma
3)Individuals willing to provide informed consent
 
 
ExclusionCriteria 
Details  1)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.
2)Individuals wearing partial or complete dentures
3)Those with opium addiction or drug abuse
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1)Prevalence of bronchial asthma in periodontitis patients.2)Association between severity of periodontitis and bronchial asthma  Baseline- upon enrollment 
 
Secondary Outcome  
Outcome  TimePoints 
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 
 
Target Sample Size   Total Sample Size="400"
Sample Size from India="400" 
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)   29/07/2024 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

 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..


 
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