Analysis of Cell-free DNA (cfDNA) During Periodontitis

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

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Periodontal Diseases
• Intervention / Treatment: Other: Clinical Attachment level

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.

• Study Type: Observational
• Enrollment (Actual): 122

Contacts and Locations

Study Locations

• Italy
  • CT
    • Catania, CT, Italy, 95124
      • University of Catania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

healthy controls (n=30) and subjects with CVD (n=31), periodontitis (n=31) and periodontitis+CVD (n=30) were enrolled.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control; Evaluation of plasma cfDNA levels	Other: Clinical Attachment level; 1-year; Other Names: Evaluation of changes (in millimeters) of Clinical attachment level loss
Periodontitis; Evaluation of plasma cfDNA levels	Other: Clinical Attachment level; 1-year; Other Names: Evaluation of changes (in millimeters) of Clinical attachment level loss
Cardiovascular disease; Evaluation of plasma cfDNA levels	Other: Clinical Attachment level; 1-year; Other Names: Evaluation of changes (in millimeters) of Clinical attachment level loss
Periodontitis + cardiovascular disease; Evaluation of plasma cfDNA levels	Other: Clinical Attachment level; 1-year; Other Names: Evaluation of changes (in millimeters) of Clinical attachment level loss

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical attachment level loss	Evaluation of changes (in millimeters) of Clinical attachment level loss	baseline changes
circulating cell-free DNA	Evaluation of changes (in millimeters) of plasma circulating cell-free DNA	baseline changes

Collaborators and Investigators

• Sponsor: University of Catania
• Investigators: Principal Investigator: Gaetano Isola, Universita degli Studi di Catania

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2019
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: October 18, 2022
• First Submitted That Met QC Criteria: October 18, 2022
• First Posted (Actual): October 21, 2022

Study Record Updates

• Last Update Posted (Actual): May 23, 2023
• Last Update Submitted That Met QC Criteria: May 21, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Cardiovascular Diseases; Periodontitis; Periodontal Diseases
• Other Study ID Numbers: 121/20/22/PO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: all collected IPD, all IPD that underlie results in a publication

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No