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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03297749

Enrollment

102

Registered

2017-09-29

Start date

2015-07-01

Completion date

2020-12-31

Last updated

2017-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Syndrome, Periodontitis, Adult

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.

Interventions

OTHERObservational study (no intervention)

No interventions

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
subgingival microbes	baseline
inflammatory markers	baseline

Countries

Italy, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026