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

April 12, 2023 updated by: Dr.Jaideep Mahendra, Meenakshi Ammal Dental College and Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Tamil NADU
      • Chennai, Tamil NADU, India, 600095
        • Meenakshi Ammal Dental college and hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

28 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meenakshi Ammal Dental College and Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2023

Primary Completion (Anticipated)

December 30, 2023

Study Completion (Anticipated)

May 1, 2024

Study Registration Dates

First Submitted

November 10, 2022

First Submitted That Met QC Criteria

December 21, 2022

First Posted (Actual)

December 23, 2022

Study Record Updates

Last Update Posted (Actual)

April 13, 2023

Last Update Submitted That Met QC Criteria

April 12, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MADC/IEC-1/18/2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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