Analysis of Cell-free DNA (cfDNA) During Periodontitis

Completed

• Conditions: Periodontal Diseases; Cardiovascular Diseases
• Interventions: Other: Clinical Attachment level

• Registration Number: NCT05590780
• Lead Sponsor: University of Catania

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.

Study Timeline

• Study Start: 2019-11-01
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30
• Study First Submitted: 2022-10-18
• Study First Submitted QC: 2022-10-18
• Study First Posted: 2022-10-21
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-21
• Last Update Posted: 2023-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control	Clinical Attachment level	Evaluation of plasma cfDNA levels
Periodontitis	Clinical Attachment level	Evaluation of plasma cfDNA levels
Cardiovascular disease	Clinical Attachment level	Evaluation of plasma cfDNA levels
Periodontitis + cardiovascular disease	Clinical Attachment level	Evaluation of plasma cfDNA levels

Primary Outcome Measures

Name	Time	Method
Clinical attachment level loss	baseline changes	Evaluation of changes (in millimeters) of Clinical attachment level loss
circulating cell-free DNA	baseline changes	Evaluation of changes (in millimeters) of plasma circulating cell-free DNA

Trial Locations

Locations (1)

University of Catania; 🇮🇹 Catania, CT, Italy