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

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03297749
• Other study ID #: 4242/01
• Status: Active, not recruiting
• Phase: N/A
• First received: September 26, 2017
• Last updated: October 25, 2017
• Start date: July 1, 2015
• Est. completion date: December 31, 2020

Study information

• Verified date: September 2017
• Source: University College, London
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 102
• Est. completion date: December 31, 2020
• Est. primary completion date: September 30, 2017
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Periodontitis
• Metabolic Syndrome
• Metabolic Syndrome X
• Periodontitis
• Periodontitis, Adult
• Syndrome

Intervention

Other:
• Observational study (no intervention)
No interventions

Locations

Country	Name	City	State
Italy	University of Catania	Catania
United Kingdom	UCL	London

Sponsors (2)

Lead Sponsor	Collaborator
University College, London	University of Catania

Countries where clinical trial is conducted

Italy,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pulse wave velocity		baseline
Primary	oxidative stress		baseline
Primary	carotid intima-media thickness		baseline
Primary	genetic variants		baseline
Primary	left ventricular mass		baseline
Secondary	inflammatory markers		baseline
Secondary	subgingival microbes		baseline