Analysis of Cell-free DNA (cfDNA) During Periodontitis

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Periodontal Diseases, Cardiovascular Diseases

Intervention / Treatment
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* Other: Clinical Attachment level


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control<br>Evaluation of plasma cfDNA levels | Other: Clinical Attachment level<br>* 1-year<br>* Other names: Evaluation of changes (in millimeters) of Clinical attachment level loss;|
| Periodontitis<br>Evaluation of plasma cfDNA levels | Other: Clinical Attachment level<br>* 1-year<br>* Other names: Evaluation of changes (in millimeters) of Clinical attachment level loss;|
| Cardiovascular disease<br>Evaluation of plasma cfDNA levels | Other: Clinical Attachment level<br>* 1-year<br>* Other names: Evaluation of changes (in millimeters) of Clinical attachment level loss;|
| Periodontitis + cardiovascular disease<br>Evaluation of plasma cfDNA levels | Other: Clinical Attachment level<br>* 1-year<br>* Other names: Evaluation of changes (in millimeters) of Clinical attachment level loss;|

What is the study measuring?
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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 |