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

Sponsor
Meenakshi Ammal Dental College and Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05663476
Collaborator
(none)
60
1
3
16
3.8

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Non Surgical Periodontal Therapy
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Three arm clinical trialThree arm clinical trial
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effect Of Non Surgical Therapy On Vitronectin And Fetuin-A Levels In Patients With Periodontitis And Coronary Artery Disease- An Interventional Study
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Dec 30, 2023
Anticipated Study Completion Date :
May 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Reduction in periodontal parameters [Two years]

    Reduction in PPD (measured in mm)

  2. Reduction in periodontal variables [Two years]

    Reduction in CAL (measured in mm)

  3. Reduction in periodontal criteria [Two years]

    Reduction in Plaque Index (measured in numericals)

  4. Reduction in periodontal variables [Two years]

    Reduction in Gingival index (measured in numericals)

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 65 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Meenakshi Ammal Dental College and Hospital Chennai Tamil NADU India 600095

Sponsors and Collaborators

  • Meenakshi Ammal Dental College and Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr.Jaideep Mahendra, Director of Research, Meenakshi Ammal Dental College and Hospital
ClinicalTrials.gov Identifier:
NCT05663476
Other Study ID Numbers:
  • MADC/IEC-1/18/2022
First Posted:
Dec 23, 2022
Last Update Posted:
Dec 23, 2022
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 23, 2022