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

NCT05663476 | Unknown

• 1 other identifier: MADC/IEC-1/18/2022
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Periodontitis; Cardiovascular Diseases; Periodontal Inflammation

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (3)

Control group

EXPERIMENTAL

Periodontally and systemically healthy participants

Other: Non Surgical Periodontal Therapy

Periodontitis without coronary artery disease

EXPERIMENTAL

Periodontitis participants without coronary artery disease

Other: Non Surgical Periodontal Therapy

Periodontitis with coronary artery disease

EXPERIMENTAL

Periodontitis participants with coronary artery disease

Other: Non Surgical Periodontal Therapy

Interventions

Non Surgical Periodontal Therapy OTHER

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

Control group; Periodontitis with coronary artery disease; Periodontitis without coronary artery disease

Eligibility Criteria

• Age: 30 Years - 65 Years
• Gender Eligibility Details: Only male participants are included belonging to 30-65 years of age
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Meenakshi Ammal Dental College and Hospital: lead

Study Sites (1)

Meenakshi Ammal Dental College and Hospital

Chennai, Tamil Nadu, 600095, India

Location

MeSH Terms

Conditions

Chronic Periodontitis; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research

Model Details: Three arm clinical trial

Study Record Dates

• First Submitted: November 10, 2022
• First Posted: December 23, 2022
• Study Start: May 1, 2023
• Primary Completion: December 30, 2023
• Study Completion: May 1, 2024
• Last Updated: April 13, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)