Analysis of Cell-free DNA (cfDNA) During Periodontitis

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05590780
• Other study ID #: 121/20/22/PO
• Status: Completed
• Start date: November 1, 2019
• Est. completion date: June 30, 2022

Study information

• Verified date: May 2023
• Source: University of Catania
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Periodontal Diseases
• Periodontitis

Intervention

Other:
• Clinical Attachment level
1-year

Locations

Country	Name	City	State
Italy	University of Catania	Catania	CT

Sponsors (1)

Lead Sponsor	Collaborator
University of Catania

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical attachment level loss	Evaluation of changes (in millimeters) of Clinical attachment level loss	baseline changes
Primary	circulating cell-free DNA	Evaluation of changes (in millimeters) of plasma circulating cell-free DNA	baseline changes