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Analysis of Cell-free DNA (cfDNA) During Periodontitis

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05590780
Enrollment
122
Registered
2022-10-21
Start date
2019-11-01
Completion date
2022-06-30
Last updated
2023-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases, Periodontal Diseases

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.

Interventions

OTHERClinical Attachment level

1-year

Sponsors

University of Catania
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
35 Years to 70 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Clinical attachment level lossbaseline changesEvaluation of changes (in millimeters) of Clinical attachment level loss
circulating cell-free DNAbaseline changesEvaluation of changes (in millimeters) of plasma circulating cell-free DNA

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026