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Genetic Variants and Oxidative Stress as Links Between Periodontitis and Metabolic Syndrome

NCT ID: NCT03297749

Last Updated: 2017-10-26

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

UNKNOWN

Total Enrollment

102 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-07-01

Study Completion Date

2020-12-31

Brief Summary

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The aim of this study is to investigate the systemic impact of periodontitis in patients with Metabolic Syndrome, by assessing measures of sub-clinical atherosclerosis and cardiovascular risk, microbial factors and host genetic variants, and to study the possible effect of mediators of inflammation and oxidative stress as links between the two conditions.

Detailed Description

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This is a cross-sectional study. 102 patients with metabolic syndrome will be recruited and will have periodontal and dental examination for diagnosis of caries and periodontal diseases. They will undergo blood, saliva, GCF and subgingival plaque sampling and a series of tests on cardiovascular disease, including measures of pulse-wave velocity,carotid intima-media thickness and echocardiography assessment. Statistical analysis will assess associations between dental diagnoses and metabolic, cardiovascular, inflammatory, genetic, microbial and cardiovascular risk outcomes.

Conditions

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Periodontitis, Adult Metabolic Syndrome

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Interventions

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Observational study (no intervention)

No interventions

Intervention Type OTHER

Other Intervention Names

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No interventions

Eligibility Criteria

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Inclusion Criteria

* Caucasian ethnicity
* Age 18- 75
* Diagnosis of metabolic syndrome
* Presence of at least 12 teeth

Exclusion Criteria

* Pregnancy
* Presence of infectious diseases such as hepatitis and HIV
* Use of non-steroidal anti-inflammatory drugs (excluding low-dose aspirin) within one month prior to the baseline visit
* Use of systemic antibiotics within three months prior to the baseline visit
* Antibiotic pre-medication required for the performance of periodontal examination
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Catania

OTHER

Sponsor Role collaborator

University College, London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Catania

Catania, , Italy

Site Status

UCL

London, , United Kingdom

Site Status

Countries

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Italy United Kingdom

References

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Nibali L, Donos N, Terranova V, Di Pino A, Di Marca S, Ferrara V, Pisano M, Scicali R, Rabuazzo AM, Purrello F, Malatino L. Left ventricular geometry and periodontitis in patients with the metabolic syndrome. Clin Oral Investig. 2019 Jun;23(6):2695-2703. doi: 10.1007/s00784-018-2667-8. Epub 2018 Oct 22.

Reference Type DERIVED
PMID: 30350134 (View on PubMed)

Other Identifiers

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4242/01

Identifier Type: -

Identifier Source: org_study_id