Cardiovascular Diseases Clinical Trial
Official title:
Analysis of Gingival Crevicular Fluid Levels of miRNA 7a-5p, miRNA 21-3p, miRNA 21-5p, miRNA 200b-3p, miRNA 200b-5p, miRNA 100-5p, miRNA 125-5p in CVD and Periodontitis
| NCT number | NCT05383794 |
| Other study ID # | 215-21/PO |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | April 1, 2019 |
| Est. completion date | December 15, 2021 |
| Verified date | May 2022 |
| Source | University of Catania |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
Several micro-RNA plays a key role in endothelial function and may be a link for the known interaction of periodontitis and cardiovascular disease. The investigators compared the impact of gingival health, periodontitis (CP), cardiovascular disease or of both diseases (CP +cardiovascular disease) on gingival crevicular fluid miRNA 7a-5p, miRNA 21-3p, miRNA 21-5p, miRNA 200b-3p, miRNA 200b-5p, miRNA 100-5p, miRNA 125-5p levels.
| Status | Completed |
| Enrollment | 115 |
| Est. completion date | December 15, 2021 |
| Est. primary completion date | October 30, 2021 |
| Accepts healthy volunteers | |
| Gender | All |
| Age group | N/A and older |
| 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. |
| Country | Name | City | State |
|---|---|---|---|
| Italy | University of Catania | Catania | CT |
| Lead Sponsor | Collaborator |
|---|---|
| University of Catania |
Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Clinical Attachment level | Evaluation of changes (in millimeters) of Clinical attachment level loss | 1-year |
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