Analysis of Cell-free DNA (cfDNA) During Periodontitis
Analysis of the Impact of Cell-free DNA (cfDNA) During Periodontitis and Cardiovascular Disease
1 other identifier
observational
122
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2019
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2022
CompletedFirst Submitted
Initial submission to the registry
October 18, 2022
CompletedFirst Posted
Study publicly available on registry
October 21, 2022
CompletedMay 23, 2023
May 1, 2023
2.7 years
October 18, 2022
May 21, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
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
Study Arms (4)
Control
Evaluation of plasma cfDNA levels
Periodontitis
Evaluation of plasma cfDNA levels
Cardiovascular disease
Evaluation of plasma cfDNA levels
Periodontitis + cardiovascular disease
Evaluation of plasma cfDNA levels
Interventions
1-year
Eligibility Criteria
healthy controls (n=30) and subjects with CVD (n=31), periodontitis (n=31) and periodontitis+CVD (n=30) were enrolled.
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Catania
Catania, CT, 95124, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gaetano Isola
Università degli Studi di Catania
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Researcher
Study Record Dates
First Submitted
October 18, 2022
First Posted
October 21, 2022
Study Start
November 1, 2019
Primary Completion
June 30, 2022
Study Completion
June 30, 2022
Last Updated
May 23, 2023
Record last verified: 2023-05