Role of miRNAs in CVD and Periodontitis

NCT ID: NCT05383794

Last Updated: 2022-05-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

115 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-01

Study Completion Date

2021-12-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cardiovascular Diseases Periodontal Diseases

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Control

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.

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.

Intervention Type OTHER

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.

Periodontitis

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.

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.

Intervention Type OTHER

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.

Cardiovascular disease

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.

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.

Intervention Type OTHER

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.

Periodontitis + cardiovascular disease

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.

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.

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

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.
Eligible Sex

Accepts Healthy Volunteers

No

Sponsors

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University of Catania

OTHER

Sponsor Role lead

Responsible Party

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Gaetano Isola

Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gaetano Isola

Role: PRINCIPAL_INVESTIGATOR

Università degli Studi di Catania

Locations

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University of Catania

Catania, CT, Italy

Site Status

Countries

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Italy

Other Identifiers

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215-21/PO

Identifier Type: -

Identifier Source: org_study_id

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