Periodontal Assessment of a Bariatric Care Population (Bariatric)

June 6, 2025 updated by: Queen Mary University of London

Periodontal Assessment of a Bariatric Care Population, Clinical, Genetic and Microbiological Characteristics. A Cross-sectional Study.

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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

394

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
      • London, United Kingdom, E1 2AD
        • Recruiting
        • Centre for Oral Clinical Research (COCR)
        • Contact:
        • Contact:
      • London, United Kingdom, E1 1BB
      • London, United Kingdom
        • Recruiting
        • St Bartholomew's Hospital, Barts Health NHS Trust
        • Contact:
          • Anjali Zalin, Dr
      • Luton, United Kingdom
        • Recruiting
        • Luton and Dunstable University Hospital
        • Contact:
          • Anjali Zalin, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of Periodontal Disease in an Obese Population
Time Frame: Cross-sectional study, single visit study so only one time point. Up to two hours from consent to obtain the BPE examination and full mouth periodontal examination.
Basic Periodontal Examination (BPE) scores and full mouth periodontal examination. BPE scores are given per sextant of the mouth and they can take values of 0 to 4 and or asterisk.
Cross-sectional study, single visit study so only one time point. Up to two hours from consent to obtain the BPE examination and full mouth periodontal examination.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Investigation of inflammatory biomarkers that have been previously been associated with Periodontal Disease in the saliva of obese patients.
Time Frame: Cross-sectional study, single visit study so only one time point at the collection of the salivary sample. Up to two hours from consent to obtain the sample.
Salivary samples aliquots will be analysed with Elisa or Multiplex assay for a series of human inflammatory markers of interest. The results of the quantitative analysis will be combined with the clinical findings to investigate for correlation with the periodontal disease status of the patients.
Cross-sectional study, single visit study so only one time point at the collection of the salivary sample. Up to two hours from consent to obtain the sample.
Correlation of FTO gene (Obesity) polymorphisms with the prevalence of PD in obese population
Time Frame: Cross-sectional study, single visit study so only one time point at the collection of the blood sample.Up to two hours from consent to obtain the sample.
DNA will be extracted from venepunctured blood and will be genotyped for the FTO polymorphism at position rs9939609. The presence of the rare allele will be analysed with the clinical findings to investigate for correlation with the periodontal disease status of the patients.
Cross-sectional study, single visit study so only one time point at the collection of the blood sample.Up to two hours from consent to obtain the sample.
Correlation of subgingival microbial flora in obese patients with and without periodontitis.
Time Frame: Cross-sectional study, single visit study so only one time point at the collection of the sample. Up to two hours from consent to obtain the sample.
Salivary samples aliquots and subgingival bacterial samples will be used for extraction and genotyping of bacterial DNA using high throughput sequencing. Bioinformatics will be used to correlate between periodontal disease status and bacterial microbiome.
Cross-sectional study, single visit study so only one time point at the collection of the sample. Up to two hours from consent to obtain the sample.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen Mary University of London

Collaborators

University College London Hospitals

Investigators

  • Principal Investigator: Nikolaos Donos, Prof., Professor of Periodontology and Implantology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 31, 2014

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

March 8, 2021

First Submitted That Met QC Criteria

April 15, 2021

First Posted (Actual)

April 20, 2021

Study Record Updates

Last Update Posted (Actual)

June 8, 2025

Last Update Submitted That Met QC Criteria

June 6, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • IRAS ID 108243

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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