FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/07/070040 [Registered on: 05/07/2024] Trial Registered Prospectively
Last Modified On: 04/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   Examination of saliva and Blood components substances in patient with gum diseases along with heart disease 
Scientific Title of Study   Evaluation Of Serum and Salivary Mitofusin-1 and Mitofusin-2 and its Association with Periodontal Diseases and Atherosclerotic Cardiovascular Diseases 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kaviyapriya 
Designation  Post Graduate 
Affiliation  SRM Dental College 
Address  Department Of Periodontics SRM Dental college Bharathi Salai Ramapuram Chennai

Chennai
TAMIL NADU
600089
India 
Phone  8056956543  
Fax    
Email  kvpriya888@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Priyanka 
Designation  Associate Professor 
Affiliation  SRM Dental College 
Address  Department Of Periodontics SRM Dental college Bharathi Salai Ramapuram Chennai

Chennai
TAMIL NADU
600089
India 
Phone  9840771507  
Fax    
Email  priyankacholan@gmail.com  
 
Details of Contact Person
Public Query  
Name  Priyanka 
Designation  Associate Professor 
Affiliation  SRM Dental College 
Address  Department Of Periodontics SRM Dental college Bharathi Salai Ramapuram Chennai


TAMIL NADU
600089
India 
Phone  9840771507  
Fax    
Email  priyankacholan@gmail.com  
 
Source of Monetary or Material Support  
Department Of Periodontics 3RD Floor post Graduate Clinic SRM Dental College and Hospitals Bharathi salai Ramapuram Chennai 600089 Tamilnadu 
 
Primary Sponsor  
Name  Kaviyapriya.A 
Address  Department Of Periodontics SRM Dental College Bharathi Salai Ramapuram Chennai 600089 
Type of Sponsor  Other [Self Funded] 
 
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 Priyankacholan  SRM Dental College And Hospitals  Department Of Periodontics 3rd Floor Post Graduate Clinic Bharathi salai Ramapuram Chennai 600089
Chennai
TAMIL NADU 		 9840771507

priyankacholan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE AND REVIEW BOARD SRM DENTAL COLLEGE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Systemically Healthy Subjects With Clinically Healthy Gingiva 
Patients  (1) ICD-10 Condition: K053||Chronic periodontitis, (2) ICD-10 Condition: I219||Acute myocardial infarction, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Inclusion criteria for healthy individuals:
Based on the classification system introduced by Kornman and Tonetti et al, 2018.
1. Pristine periodontal health:
· No bleeding on probing.
· Normal gingival sulcus depth.
· Normal bone heights.
· Controlled modifying factors.
· Controlled predisposing factors.

2.Clinical periodontal health (intact periodontium):
· No or minimal bleeding on probing.
· Normal gingival sulcus depth.
· Normal bone heights.
· Controlled modifying factors.
· Controlled predisposing factors.
IInclusion criteria for Stage III/IV Periodontitis:
Based on the classification system introduced by Kornman and Tonetti et al, 2018.

1.Stage III:
• Interdental clinical attachment loss at site of greatest loss ≥ 5mm.
• Radiographic bone loss extending to middle or apical third of root
• Tooth loss due to periodontitis ≤ 4 teeth.
• Probing depth ≥ 6mm.
• Extent: Greater than 30% of teeth involved (Generalized)
2.Stage IV:
• Interdental clinical attachment loss at site of greatest loss ≥ 5mm.
• Radiographic bone loss extending to middle or apical third of root
• Tooth loss due to periodontitis ≥ 5 teeth.
• Extent: Greater than 30% of teeth involved (Generalized)
Atherosclerosis in this study is defined as an event of Acute Myocardial Infarction, Acute coronary syndrome, patients with defined coronary artery disease (Coronary angiography) and patients post bypass and post stenting. Patients with aortic aneurysms (pathogenesis –atherosclerosis)
Inclusion criteria for cardiovascular patients:
1.History of angina and not consuming lipid lowering drugs(statins)
2.Borderline high to high lipid profile inclusive of total cholesterol, Triglycerides and LDL (As per NCEP-ATP III classification)
a. Total cholesterol level above 200 mg/dL
b. Triglycerides above 150 mg/dL
c.HDL above 60 mg/dL
d.LDL above 130mg/dL
 
 
ExclusionCriteria 
Details  1. Patients with immunodeficiency disorders.
2. Patients with other systemic inflammatory conditions like sepsis, pneumonia, pleural effusion, intra-abdominal infections, inflammatory bowel disorders, inflammatory rheumatoid disorders, chronic kidney disease, Diabetes, cancers, COPD, asthma, HIV and hepatitis will be excluded from the study.
3. History of periodontal treatment within the last 6 months.
4. History of antibiotic therapy in the past 3 months.
5. Subjects who are not willing to participate in the study. 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
To correlate the ability of Mitofusin-1 and Mitofusin-2 as a potential common Serum and Salivary biomarker for stage III/IV Periodontitis and risk of developing Atherosclerotic cardiovascular disease
 		 Baseline
 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="76"
Sample Size from India="76" 
Final Enrollment numbers achieved (Total)= "76"
Final Enrollment numbers achieved (India)="76" 
Phase of Trial   N/A 
Date of First Enrollment (India)   05/08/2024 
Date of Study Completion (India) 05/08/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  
   In Periodontal diseases, mitochondrial dynamics are influenced in several ways such as reduced energy production and increased production of Reactive oxygen species(ROS) Dysregulated mitochondrial dynamics also affect the apoptosis of host cells and immune cells, impacting the overall homeostasis in the periodontal dysbiotic environment And In atherosclerosis, Mitochondrial dysfunction influenced in increased ROS production and oxidative damage. Disrupted mitochondrial dynamics in endothelial cells impair nitric oxide bioavailability, worsening endothelial dysfunction, a critical early event in early plaque formation.Mitochondrial dynamics are influencing in regulation of inflammation and plays a crucial role in both periodontal and cardiovascular diseases. Dysfunctional mitochondrial dynamics can lead to increased oxidative stress and inflammation, which are key drivers in the pathogenesis of both diseases .Mitochondrial dysfunction is linked to Mitofusin proteins, namely Mitofusin-1 and Mitofusin-2. Modulating mitochondrial fusion through these proteins may influence the release of inflammatory mediators Alterations in the levels of Mitofusin-1 and Mitofusin-2 could impact cellular susceptibility to apoptosis, potentially affecting overall tissue integrity in both periodontitis and cardiovascular diseases.Hence , we aim to assess, compare and correlate the ability of MFN1 & MFN2 as a potential common Serum and Salivary biomarker for stage III/IV Periodontitis and risk of developing Atherosclerotic cardiovascular diseases.  
 
Close