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

• Conditions: Metabolic Syndrome; Periodontitis, Adult

• Registration Number: NCT03297749
• Lead Sponsor: University College, London

Brief Summary

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

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.

Study Timeline

• Study Start: 2015-07-01
• Status Verified: 2017-09
• Study First Submitted: 2017-09-26
• Study First Submitted QC: 2017-09-26
• Study First Posted: 2017-09-29
• Primary Completion: 2017-09-30
• Last Update Submitted: 2017-10-25
• Last Update Posted: 2017-10-26
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 102

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
left ventricular mass	baseline
pulse wave velocity	baseline
oxidative stress	baseline
carotid intima-media thickness	baseline
genetic variants	baseline

Secondary Outcome Measures

Name	Time	Method
inflammatory markers	baseline
subgingival microbes	baseline

Trial Locations

Locations (2)

UCL; 🇬🇧 London, United Kingdom

University of Catania; 🇮🇹 Catania, Italy