NCT05383794

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
115

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2019

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 20, 2022

Completed
Last Updated

May 20, 2022

Status Verified

May 1, 2022

Enrollment Period

2.6 years

First QC Date

May 16, 2022

Last Update Submit

May 16, 2022

Conditions

Cardiovascular DiseasesPeriodontal Diseases

Outcome Measures

Primary Outcomes (1)

  • Clinical Attachment level

    Evaluation of changes (in millimeters) of Clinical attachment level loss

    1-year

Study Arms (4)

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.

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.

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.

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.

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.

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.

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.

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.

Interventions

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.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 diseaseControlPeriodontitisPeriodontitis + cardiovascular disease

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

healthy controls (n=28), periodontitis (n=30), CVD (n=28), and a combination of periodontitis + CVD (n=29)

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

Location

MeSH Terms

Conditions

Cardiovascular DiseasesPeriodontal Diseases

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Study Officials

  • Gaetano Isola

    Università degli Studi di Catania

    PRINCIPAL INVESTIGATOR

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

May 16, 2022

First Posted

May 20, 2022

Study Start

April 1, 2019

Primary Completion

October 30, 2021

Study Completion

December 15, 2021

Last Updated

May 20, 2022

Record last verified: 2022-05

Locations

IT(1)