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Completed

NCT Number: NCT05590780

Analysis of Cell-free DNA (cfDNA) During Periodontitis

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.

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Key information

Conditions

Periodontal Diseases Cardiovascular Diseases Mouth Diseases Stomatognathic Diseases

Age range

35 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Catania

Catania, CT, 95124, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Clinical Attachment level

Other

1-year

Other names: Evaluation of changes (in millimeters) of Clinical attachment level loss

Primary outcomes

  1. Clinical attachment level loss

    Time frame: baseline changes

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

  2. circulating cell-free DNA

    Time frame: baseline changes

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

Sponsors and collaborators

Lead sponsor

University of Catania

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Oct 21, 2022
Registry last updated
May 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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