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

NCT ID: NCT05663476

Last Updated: 2023-04-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2024-05-01

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.

Conditions

Chronic Periodontitis; Cardiovascular Diseases; Periodontal Inflammation

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control group

Periodontally and systemically healthy participants

Group Type: EXPERIMENTAL

Non Surgical Periodontal Therapy

Intervention Type: OTHER

Scaling and root planing using scalers and periodontal curettes will be done

Periodontitis without coronary artery disease

Periodontitis participants without coronary artery disease

Group Type: EXPERIMENTAL

Non Surgical Periodontal Therapy

Intervention Type: OTHER

Scaling and root planing using scalers and periodontal curettes will be done

Periodontitis with coronary artery disease

Periodontitis participants with coronary artery disease

Group Type: EXPERIMENTAL

Non Surgical Periodontal Therapy

Intervention Type: OTHER

Scaling and root planing using scalers and periodontal curettes will be done

Interventions

Non Surgical Periodontal Therapy

Scaling and root planing using scalers and periodontal curettes will be done

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Meenakshi Ammal Dental College and Hospital

OTHER

Sponsor Role: lead

Responsible Party

Dr.Jaideep Mahendra

Director of Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Meenakshi Ammal Dental College and Hospital

Chennai, Tamil Nadu, India

Countries

India

Facility Contacts

Dr. JAIDEEP MAHENDRA, M.D.S, Ph.D. Post Doc (USA)

Role: primary

jaideep_m_23@yahoo.co.in

09444963973

Dr. PAVITHRA H DAVE, BDS

Role: backup

pavithradave1997@gmail.com

09962705033

Other Identifiers

MADC/IEC-1/18/2022

Identifier Type: -

Identifier Source: org_study_id