NSPT On Vitronectin And Fetuin-A Levels In Patients With Periodontitis And Coronary Artery Disease

Study Overview
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Brief Summary
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Periodontitis is a chronic inflammatory disease mainly caused by the oral microbial biofilm. It involves the periodontal supporting tissues mainly features gum inflammation, alveolar bone resorption, periodontal pocket formation, and tooth loosening but also induces various systemic diseases, which seriously affect the physical and mental health of patients. The response to periodontal infection is mediated by various intracellular signalling pathways leading to the production of numerous bio-molecules. Vitronectin is a multifunctional protein with a multiple binding domain that interacts with a variety of plasma and cell proteins. It belongs to the group of adhesive glycoproteins that is involved in various functions including complement activation, blood coagulation, binding to proteoglycans, and modification of the matrix. Among the various cystatins expressed in serum and saliva, Fetuin-A, an another protein is produced majorly by healthy hepatic and adipose tissues. Fetuin-A has been recognized as a multifunctional molecule related to its role in metabolic processes, insulin resistance, regulation of adipogenesis and mineralization throughout the body. The study aims to determine the expression of Vitronectin and Fetuin-A as potential pro-inflammatory and anti-inflammatory biomarkers respectively. These protein molecules can further play a role as putative risk indicators in periodontitis subjects with and without coronary artery disease following non-surgical therapy.

Detailed Description
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Periodontitis is a chronic inflammatory disease mainly caused by the oral microbial biofilm. It involves the periodontal supporting tissues mainly features gum inflammation, alveolar bone resorption, periodontal pocket formation, and tooth loosening but also induces various systemic diseases, which seriously affect the physical and mental health of patients. The response to periodontal infection is mediated by various intracellular signaling pathways leading to the production of numerous bio-molecules. Vitronectin is a multifunctional protein with multiple binding domains that interact with a variety of plasma and cell proteins. It belongs to the group of adhesive glycoproteins that are involved in various functions including complement activation, blood coagulation, binding to proteoglycans, and modification of the matrix. Among the various cystatins expressed in serum and saliva, Fetuin-A, another protein is produced majorly by healthy hepatic and adipose tissues. Fetuin-A has been recognized as a multifunctional molecule related to its role in metabolic processes, insulin resistance, regulation of adipogenesis, and mineralization throughout the body. To find out the effect of non-surgical therapy on the periodontal and cardiac parameters and the salivary levels of Vitronectin and Fetuin-A in patients with periodontitis (stage II-III) and coronary artery disease.

Official Title
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Effect Of Non Surgical Therapy On Vitronectin And Fetuin-A Levels In Patients With Periodontitis And Coronary Artery Disease- An Interventional Study

Conditions
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Cardiovascular Diseases, Chronic Periodontitis, Periodontal Inflammation

Intervention / Treatment
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* Other: Non Surgical Periodontal Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients willing to participate in the study. Patients within the age group of 30-65 years (male) Patients should have ≥ 10 remaining natural teeth. No history of long term antibiotic use in past 6 months. Exclusion Criteria: Subjects with systemic conditions such as type I and type II diabetes mellitus, respiratory diseases, renal disease, liver disease, rheumatoid arthritis, allergy, advanced malignancies/neoplasm and HIV infection will be excluded from the present investigation. Chronic treatment (>2 weeks) with drugs known to affect periodontal tissues (phenytoin or cyclosporin). Female patients were excluded due to hormonal variations. For Group II and III, subjects on drugs such as corticosteroids, antibiotics, within 6 months of investigation will be excluded. Current smokers and individuals who quit smoking less than 6 months. Patients who have undergone periodontal therapy within the previous 6 months.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Three arm clinical trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Control group<br>Periodontally and systemically healthy participants | Other: Non Surgical Periodontal Therapy<br>* Scaling and root planing using scalers and periodontal curettes will be done<br>|
| Experimental: Periodontitis without coronary artery disease<br>Periodontitis participants without coronary artery disease | Other: Non Surgical Periodontal Therapy<br>* Scaling and root planing using scalers and periodontal curettes will be done<br>|
| Experimental: Periodontitis with coronary artery disease<br>Periodontitis participants with coronary artery disease | Other: Non Surgical Periodontal Therapy<br>* Scaling and root planing using scalers and periodontal curettes will be done<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in periodontal parameters | Reduction in PPD (measured in mm) | Two years | 
| Reduction in periodontal variables | Reduction in CAL (measured in mm) | Two years | 
| Reduction in periodontal criteria | Reduction in Plaque Index (measured in numericals) | Two years | 
| Reduction in periodontal variables | Reduction in Gingival index (measured in numericals) | Two years |