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Periodontal Assessment of a Bariatric Care Population

Sponsor: Queen Mary University of London

NCT ID: NCT04851470

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Not specified by the sponsor
How long the study runs
Study runs about 167 months (dates as stated)
About the drug or intervention
Not specified by the sponsor
Patient visit burden
Not specified by the sponsor
Type of study
Observing health over time
Ages
18 Years and over
Who
All
Number of participants
394
Started
2014-01-31
Last checked
2026-07

Plain English Summary

What is this study?

  • • Testing a new treatment for bariatric surgery candidate
  • • Clinical study - 394 participants
  • • Our primary aim is to investigate the prevalence and severity of Periodonotal Disease (PD) in a population of obese patients

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with bariatric surgery candidate

Where?

  • • London - Barts Health NHS Trust Dental Hospital
  • • London - Centre for Oral Clinical Research (COCR)
  • • London - St Bartholomew's Hospital, Barts Health NHS Trust
  • • Luton - Luton and Dunstable University Hospital

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

Our primary aim is to investigate the prevalence and severity of Periodonotal Disease (PD) in a population of obese patients. 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.

More detail

Overall design and plan of the study This is a cross-sectional association study. The study population will be recruited among individuals attending the UCLH Centre for Weight Loss, Metabolic \& Endocrine Surgery (UCLH bariatric clinic) and have given written informed consent to the study. 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.

Bariatric Surgery CandidateObesity

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Treatment history

Treatments you must have had:

  • ✓ a BMI of higher or equal to 30 kg/ m2
  • ✓ voluntarily given written informed consent

What the study is looking for

  • ✓Each subject must meet all of the following inclusion criteria to be enrolled in the study:
  • ✓Subject must be over 18 years of age.
  • ✓Subject must have a BMI of higher or equal to 30 kg/ m2
  • ✓Subject must have voluntarily given written agreement to take part.

Who cannot take part

  • ✗Subjects meeting any of the following exclusion criteria are not to be enrolled in the study:
  • ✗Subject is currently involved in other research involving the use of antibiotics or novel or unknown medications.
  • ✗Self-reported pregnancy.
  • ✗Subject is on chronic treatment (i.e., two weeks or more) with specific medications known to affect periodontal...
  • ✗Subject knowingly has HIV or Viral Hepatitis.
See the full criteria
Inclusion Criteria: Each subject must meet all of the following inclusion criteria to be enrolled in the study: 1. Subject must be over 18 years of age. 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: Subjects meeting any of the following exclusion criteria are not to be enrolled in the study: 1. Subject is currently involved in other research involving the use of antibiotics or novel or unknown medications. 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).

Where Is This Study? (4 UK sites)

Barts Health NHS Trust Dental Hospital

London E1 1BB, United Kingdom

Recruiting
Site contact (verified)
Nikolaos Donos, DDS PhDPrincipal Investigator

Centre for Oral Clinical Research (COCR)

London E1 2AD, United Kingdom

Recruiting
Site contact (verified)
Nikolaos Gkranias, DDS, PhDn.gkranias@qmul.ac.uk

St Bartholomew's Hospital, Barts Health NHS Trust

London, United Kingdom

Recruiting
Hospital R&D contact (matched)

Dr Mays Jawad

research.governance@qmul.ac.uk020 7882 6826

Luton and Dunstable University Hospital

Luton, United Kingdom

Recruiting
Hospital R&D contact (matched)

Dr. Mohammad Wasil. Assistant Director of RD&I

research.bedford@bedsft.nhs.ukContact:

How to Get in Touch

Vandana Luthra, Dr.

Sponsor contact

CONTACT

02078826348 BHNT.Clinicaloralresearchcentre@nhs.net
Data sourced from ClinicalTrials.gov · Last verified: 2026-07