| CTRI Number |
CTRI/2022/11/047683 [Registered on: 25/11/2022] Trial Registered Prospectively |
| Last Modified On: |
02/11/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
To study the association of Pyorrhoea ( gum disease ) and irregular heart beat |
|
Scientific Title of Study
|
Understanding the association of periodontitis and atrial tachyarrhythmia – A molecular and biochemical study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Dr Sangeeta Dhir |
| Designation |
Consultant Dentistry Clinical Research |
| Affiliation |
Department of dentistry and clinical research Max Superspeciality Hospital New Delhi |
| Address |
Department of Dentistry and Clinical Research
Max Superspeciality Hospital
2 press enclave Road Saket
New Delhi
New Delhi
DELHI
110017
India |
| Phone |
|
| Fax |
|
| Email |
sangeetadhir@smilinedental.com |
|
Details of Contact Person
Scientific Query
|
| Name |
ProfDrSangeeta Dhir |
| Designation |
Consultant Dentistry Clinical Research |
| Affiliation |
Max Superspeciality Hospital Department of dentistry and clinical research New Delhi |
| Address |
Department of Dentistry and clinical Research
Max Superspeciality Hospital
2 press enclave Road Saket
New Delhi
New Delhi
DELHI
110017
India |
| Phone |
|
| Fax |
|
| Email |
sangeetadhir@smilinedental.com |
|
Details of Contact Person
Public Query
|
| Name |
ProfDrSangeeta Dhir |
| Designation |
Consultant Dentistry and Clinical Research |
| Affiliation |
Max Superspeciality Hospital Department of dentistry and clinical research New Delhi |
| Address |
Department of Dentistry and Clinical Research
Max Superspeciality Hospital
2 press enclave Road Saket
New Delhi
New Delhi
DELHI
110017
India |
| Phone |
|
| Fax |
|
| Email |
sangeetadhir@smilinedental.com |
|
|
Source of Monetary or Material Support
|
| Max Superspeciality Hospital Saket ,New Delhi |
|
|
Primary Sponsor
|
| Name |
Max Superspeciality Hospital |
| Address |
2. press enclave road saket , new delhi |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| Prof Dr SANGEETA DHIR |
Max Superspeciality Hospital NEW DELHI |
2 PRESS ENCLAVE ROAD SAKET NEW DELHI
Department of Cardiology and Department of Dentistry
New Delhi
DELHI |
91-9818181971
sangeetadhir@smilinedental.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DEVKI DEVI FOUNDATION |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I479||Paroxysmal tachycardia, unspecified, (2) ICD-10 Condition: I479||Paroxysmal tachycardia, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
A] Inclusion: Periodontal criteria in patients with and without arrhythmia
a. presence of minimum 12 natural evaluable teeth excluding third molar and untreated endodontically involved teeth.
b. Full mouth bleeding on probing score >20%
c. orthopantomogram (OPG) for clinical correlation
Criteria for nonvalvular atrial tacharrythmia (+)
a. nonvalvular atrial tachyarrhythmias: paroxysmal supraventricular tachycardia (PSVT), atrial fibrillation (AF), atrial tachycardia (AT) and atrial flutter (AF).
|
|
| ExclusionCriteria |
| Details |
B] Exclusion
a. presence of acute infection,
b. major trauma or surgery or any acute cardiovascular or cerebrovascular event within the preceding three months;
c. autoimmune disease, malignancy
d. connective tissue disease, ischemic heart disease
e. mechanical or surgical periodontal therapy in the last six months
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To MESURE THE PRESENCE OF PERIODNTITIS / PYOHORREA IN PATIENTS SUFFERING FROM CARDIAC ARRYTHMIA |
UPTO 3 YEARS AS STUDY TIMELINE |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Qualitative and quantitative assessment of periodontal microbiota in patients with and without arrhythmia. |
12 months |
|
|
Target Sample Size
|
Total Sample Size="408"
Sample Size from India="408"
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)
|
02/02/2023 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NONE YET FROM THIS STUDY |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response (Others) -
- What additional supporting information will be shared?
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 03-01-2025 and end date provided 03-12-2025?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Cardiac arrhythmia refer to any abnormality or disturbance in the normal activation sequence of the myocardium classified as tachycardia (>100 beats / minute ) and bradycardia. Apart from the conventional risk factors responsible for triggering arrhythmia , chronic inflammation are increasingly becoming focus for cardiac arrhytmogenesis in the recent past . Inflammation is known to be pro arrhythmic and leads to altered electrophysiologic properties in the myocardium. Periodontitis , a chronic infectious inflammatory disease , characterized by destruction of the supporting tissues around the teeth leading to bone loss and finally tooth loss. Periodontitis leads to acceleration of the systemic inflammation , through low grade chronic bacteremia ,resulting in increased levels of biomarkers : CRP, WBC, cytokines. These increased inflammatory markers have been documented for origination and progression of coronary artery disease/ atherosclerosis and also for their role in initiation and persistence of atrial fibrillation ( a prevalent type of cardiac arrhythmia .)
study purpose : To understand the risk of periodontitis in a cohort of cardiac arrhythmia patients and compared to age and SES (socioeconomic status matched) healthy cohort ( without arrhythmia ) Hypothesis Cardiac arrhythmia are associated with increased risk of periodontitis |