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To learn how gum disease and swelling in the mouth are connected to heart problems in people.

Evaluation of Follistatin Like-1 Protein And IL-6 Levels In Serum And Saliva of Patients With Atherosclerotic Cardiovascular Disease With And Without Periodontal Disease. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/05/086302
Enrollment
80
Registered
2025-05-05
Start date
Unknown
Completion date
Unknown
Last updated
2025-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I219- Acute myocardial infarction, unspecified Health Condition 2: K053- Chronic periodontitis

Interventions

Intervention1: Nil: Nil

Sponsors

Suweadha. K
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion criteria for healthy individuals: Based on the classification system introduced by Kornman and Tonetti et al, 2018 Pristine periodontal health: No bleeding on probing. Normal gingival sulcus depth. Normal bone heights. Controlled modifying factors. Controlled predisposing factors. Clinical periodontal health Intact periodontium No or minimal bleeding on probing. Normal gingival sulcus depth. Normal bone heights. Controlled modifying factors. Controlled predisposing factors. Inclusiom criteria for Stage III and IV Periodontitis: Based on the classification system introduced by Kornman and Tonetti et al, 2018. Stage III: Interdental clinical attachment loss at site of greatest loss more than equal to 5mm. Radiographic bone loss extending to middle or apical third of root Tooth loss due to periodontitis less than equal to 4 teeth. Probing depth more than equal to 6mm. Extent Greater than 30 percent of teeth involved Generalized. Stage IV: Interdental clinical attachment loss at site of greatest loss more than equal to 5mm Radiographic bone loss extending to middle or apical third of root. Tooth loss due to periodontitis more than equal to teeth. Extent: Greater than 30 percent 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. History of angina and not consuming lipid lowering drugs statins. Borderline high to high lipid profile inclusive of total cholesterol, Triglycerides and LDL As per NCEP-ATP III classification Total cholesterol level above 200mg dL Triglycerides above 150 mg dL. HDL above 60 mg dL. LDL above 130 mg dL.

Exclusion criteria

Exclusion criteria: Exclusion criteria: 1. Patients with immunodeficiency disorders. 2. Patients with other systemic inflammatory condition 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.

Design outcomes

Primary

MeasureTime frame
To evaluate the ability of Follistatin Like-1 and IL-6 as a potential common Serum and Salivary Biomarker for Stage III and IV Periodontitis and risk of developing Atheroslcerotic Cardiovascular DiseaseTimepoint: Baseline

Secondary

MeasureTime frame
NILTimepoint: NIL

Countries

India

Contacts

Public ContactSUWEADHA K

SRM Dental College

priyankacholan@gmail.com9840771507

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026