Clinical trial NCT03297749: Genetic Variants and Oxidative Stress as Links Between Periodontitis and Metabolic Syndrome
Official title: Genetic Variants and Oxidative Stress as Links Between Periodontitis and Metabolic Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Periodontitis, Adult
Metabolic Syndrome
Lead sponsor: University College, London
Sponsor class: OTHER
Collaborators: name: University of Catania
First posted: 2017-09-29
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with metabolic syndrome will be recruited from outpatients attending the Internal Medicine Unity at the University of Catania.

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.

Eligibility criteria: 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

Primary outcomes:
measure: pulse wave velocity
timeFrame: baseline
measure: oxidative stress
timeFrame: baseline
measure: carotid intima-media thickness
timeFrame: baseline
measure: genetic variants
timeFrame: baseline
measure: left ventricular mass
timeFrame: baseline
Secondary outcomes:
measure: inflammatory markers
timeFrame: baseline
measure: subgingival microbes
timeFrame: baseline
Other outcomes:
Locations:
city: Catania
country: Italy
facility: University of Catania
city: London
country: United Kingdom
facility: UCL
Study officials:
References:
citation: 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.