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Clinical Trials/NCT05590780
NCT05590780
Completed
Not Applicable

Analysis of the Impact of Cell-free DNA (cfDNA) During Periodontitis and Cardiovascular Disease

University of Catania1 site in 1 country122 target enrollmentNovember 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Periodontal Diseases
Sponsor
University of Catania
Enrollment
122
Locations
1
Primary Endpoint
Clinical attachment level loss
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

The purpose of this study was to examine the association between circulating cfDNA concentration and CVD risk in patients with periodontitis, CVD, and periodontitis plus CVD. In addition, the secondary objective was to identify, among other confounders, the impact of periodontitis and cardiovascular disease as potential significant predictors of circulating cfDNA levels in the enrolled population.

Detailed Description

Recent emerging evidence has shown that circulating cell-free (cf) DNA are involved in in several epigenetic processes linked with periodontitis, coronary stenosis and systemic inflammation. The present study was aimed at assessing the impact of periodontitis on circulating cfDNA levels and evaluating possible confounders that influenced this association. Healthy controls (n=30) and subjects with CVD (n=31), periodontitis (n=31) and periodontitis+CVD (n=30) were enrolled. All subjects underwent regular periodontal examination and blood sampling. The analysis of the plasma cfDNA concentrations was performed using a dsDNA Assay Kit.

Registry
clinicaltrials.gov
Start Date
November 1, 2019
End Date
June 30, 2022
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Gaetano Isola

Researcher

University of Catania

Eligibility Criteria

Inclusion Criteria

  • Presence of at least 15 teeth
  • CP with a minimum of 40% of sites with a clinical attachment level (CAL)
  • ≥2mm and probing depth (PD) ≥4mm;
  • Presence of at least ≥2 mm of crestal alveolar bone loss verified on digital periapical radiographs
  • Presence of ≥40% sites with bleeding on probing (BOP)

Exclusion Criteria

  • Intake of contraceptives
  • Intake of immunosuppressive or anti-inflammatory drugs throughout the last three months prior to the study
  • Status of pregnancy or lactation
  • Previous history of excessive drinking
  • Allergy to local anaesthetic
  • Intake of drugs that may potentially determine gingival hyperplasia such as Hydantoin, Nifedipine, Cyclosporin A or similar drugs.

Outcomes

Primary Outcomes

Clinical attachment level loss

Time Frame: baseline changes

Evaluation of changes (in millimeters) of Clinical attachment level loss

circulating cell-free DNA

Time Frame: baseline changes

Evaluation of changes (in millimeters) of plasma circulating cell-free DNA

Study Sites (1)

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