| 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
|
|
|
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
|
|
|
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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