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

Primary Purpose

Chronic Periodontitis, Cardiovascular Diseases, Periodontal Inflammation

Status
Not yet recruiting
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Non Surgical Periodontal Therapy
Sponsored by
Meenakshi Ammal Dental College and Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Periodontitis

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Meenakshi Ammal Dental College and Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Control group

Periodontitis without coronary artery disease

Periodontitis with coronary artery disease

Arm Description

Periodontally and systemically healthy participants

Periodontitis participants without coronary artery disease

Periodontitis participants with coronary artery disease

Outcomes

Primary Outcome Measures

Reduction in periodontal parameters
Reduction in PPD (measured in mm)
Reduction in periodontal variables
Reduction in CAL (measured in mm)
Reduction in periodontal criteria
Reduction in Plaque Index (measured in numericals)
Reduction in periodontal variables
Reduction in Gingival index (measured in numericals)

Secondary Outcome Measures

Full Information

First Posted
November 10, 2022
Last Updated
April 12, 2023
Sponsor
Meenakshi Ammal Dental College and Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05663476
Brief Title
NSPT On Vitronectin And Fetuin-A Levels In Patients With Periodontitis And Coronary Artery Disease
Official Title
Effect Of Non Surgical Therapy On Vitronectin And Fetuin-A Levels In Patients With Periodontitis And Coronary Artery Disease- An Interventional Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 1, 2023 (Anticipated)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
May 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Meenakshi Ammal Dental College and Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis, Cardiovascular Diseases, Periodontal Inflammation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Three arm clinical trial
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Experimental
Arm Description
Periodontally and systemically healthy participants
Arm Title
Periodontitis without coronary artery disease
Arm Type
Experimental
Arm Description
Periodontitis participants without coronary artery disease
Arm Title
Periodontitis with coronary artery disease
Arm Type
Experimental
Arm Description
Periodontitis participants with coronary artery disease
Intervention Type
Other
Intervention Name(s)
Non Surgical Periodontal Therapy
Intervention Description
Scaling and root planing using scalers and periodontal curettes will be done
Primary Outcome Measure Information:
Title
Reduction in periodontal parameters
Description
Reduction in PPD (measured in mm)
Time Frame
Two years
Title
Reduction in periodontal variables
Description
Reduction in CAL (measured in mm)
Time Frame
Two years
Title
Reduction in periodontal criteria
Description
Reduction in Plaque Index (measured in numericals)
Time Frame
Two years
Title
Reduction in periodontal variables
Description
Reduction in Gingival index (measured in numericals)
Time Frame
Two years

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Only male participants are included belonging to 30-65 years of age
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Meenakshi Ammal Dental College and Hospital
City
Chennai
State/Province
Tamil NADU
ZIP/Postal Code
600095
Country
India
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. JAIDEEP MAHENDRA, M.D.S, Ph.D. Post Doc (USA)
Phone
09444963973
Email
jaideep_m_23@yahoo.co.in
First Name & Middle Initial & Last Name & Degree
Dr. PAVITHRA H DAVE, BDS
Phone
09962705033
Email
pavithradave1997@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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