Study Results
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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RECRUITING
394 participants
OBSERVATIONAL
2014-01-31
2027-12-31
Brief Summary
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Our secondary objectives are to:
Investigate inflammatory biomarkers that have been associated with PD in the saliva of obese patients.
Investigate the association of FTO gene (Obesity) polymorphisms with the prevalence of PD in this population.
Investigate and describe the subgingival microbial flora in obese patients with PD from subgingival dental plaque samples as well as the salivary samples.
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Detailed Description
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Experimental Design All individuals who consent to this study will receive as part of their routine care a medical examination, where a series of parameters are recorded (including age, gender, smoking status, Bio-impedance for full body composition, ethnicity, and body mass index). These data will be copied for this study. A blood sample will also be collected for genetic analysis unless the patients have DNA already collected and it has been verified that the results are available. In that case no venepuncture will be needed.
All subjects will receive a basic periodontal examination (BPE). For individuals with signs of destructive periodontitis (BPE scores 3-4) full mouth plaque and gingival bleeding scores will also be calculated. In addition to that also a comprehensive full mouth periodontal probing depths assessment will be performed.
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Eligibility Criteria
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Inclusion Criteria
2. Subject must have a BMI of higher or equal to 30 kg/ m2
3. Subject must have voluntarily given written informed consent.
Exclusion Criteria
2. Self-reported pregnancy.
3. Subject is on chronic treatment (i.e., two weeks or more) with specific medications known to affect periodontal status (phenytoin or cyclosporine) within one month of baseline visit.
4. Subject knowingly has HIV or Viral Hepatitis.
5. Patients are completely edentulous.
6. Subject with uncontrolled systemic illnesses.
7. Subject is not capable to give informed consent.
8. Subjects on chronic antibiotic therapy (ie two weeks or more in the previous month).
18 Years
ALL
No
Sponsors
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University College London Hospitals
OTHER
Queen Mary University of London
OTHER
Responsible Party
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Principal Investigators
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Nikolaos Donos, Prof.
Role: PRINCIPAL_INVESTIGATOR
Professor of Periodontology and Implantology
Locations
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Barts Health NHS Trust Dental Hospital
London, , United Kingdom
Centre for Oral Clinical Research (COCR)
London, , United Kingdom
St Bartholomew's Hospital, Barts Health NHS Trust
London, , United Kingdom
Luton and Dunstable University Hospital
Luton, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Anjali Zalin, Dr
Role: primary
Anjali Zalin, Dr
Role: primary
Other Identifiers
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IRAS ID 108243
Identifier Type: -
Identifier Source: org_study_id
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