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

Not Applicable

Not yet recruiting

• Conditions: Chronic Periodontitis; Cardiovascular Diseases; Periodontal Inflammation
• Interventions: Other: Non Surgical Periodontal Therapy

• Registration Number: NCT05663476
• Lead Sponsor: Meenakshi Ammal Dental College and Hospital

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2022-11-10
• Study First Submitted QC: 2022-12-21
• Study First Posted: 2022-12-23
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-12
• Last Update Posted: 2023-04-13
• Study Start: 2023-05-01
• Primary Completion: 2023-12-30
• Study Completion: 2024-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 60

Inclusion Criteria

1. Patients willing to participate in the study.
2. Patients within the age group of 30-65 years (male)
3. Patients should have ≥ 10 remaining natural teeth.
4. No history of long term antibiotic use in past 6 months.

Exclusion Criteria

1. 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.
2. Chronic treatment (>2 weeks) with drugs known to affect periodontal tissues (phenytoin or cyclosporin).
3. Female patients were excluded due to hormonal variations.
4. For Group II and III, subjects on drugs such as corticosteroids, antibiotics, within 6 months of investigation will be excluded.
5. Current smokers and individuals who quit smoking less than 6 months.
6. Patients who have undergone periodontal therapy within the previous 6 months.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Periodontitis without coronary artery disease	Non Surgical Periodontal Therapy	Periodontitis participants without coronary artery disease
Control group	Non Surgical Periodontal Therapy	Periodontally and systemically healthy participants
Periodontitis with coronary artery disease	Non Surgical Periodontal Therapy	Periodontitis participants with coronary artery disease

Primary Outcome Measures

Name	Time	Method
Reduction in periodontal variables	Two years	Reduction in Gingival index (measured in numericals)
Reduction in periodontal parameters	Two years	Reduction in PPD (measured in mm)
Reduction in periodontal criteria	Two years	Reduction in Plaque Index (measured in numericals)

Trial Locations

Locations (1)

Meenakshi Ammal Dental College and Hospital; 🇮🇳 Chennai, Tamil NADU, India