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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date May 2022
Source University of Catania
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

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.

Study Design


Intervention

Other:
Observation of Evaluation of 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.
Evaluation of 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.

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 Evaluation of changes (in millimeters) of Clinical attachment level loss 1-year
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