Bariatric Surgery CandidateBariatricNCT04851470
Periodontal Assessment of a Bariatric Care Population
An observational study of Bariatric Surgery Candidate and Obesity, run by Queen Mary University of London at 4 sites in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bariatric Surgery Candidate, Obesity
- How many people
- 394 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- 31 Jan 2014to 31 Dec 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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 informed consent.
Who cannot join
- 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 status (phenytoin or cyclosporine) within one month of baseline visit.
- Subject knowingly has HIV or Viral Hepatitis.
- Patients are completely edentulous.
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- Subject with uncontrolled systemic illnesses.
- Subject is not capable to give informed consent.
- Subjects on chronic antibiotic therapy (ie two weeks or more in the previous month).
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom4 sites, 4 recruiting
- Recruiting
Barts Health NHS Trust Dental Hospital
London, E1 1BB
Nikolaos Donos, DDS, MS, FHEA, PhD, +44(0)2078823063, BHNT.Clinicaloralresearchcentre@nhs.net
Rinat Ezra Rinat, PhD, +44(0)207 882 6348, BHNT.Clinicaloralresearchcentre@nhs.net
- Recruiting
Centre for Oral Clinical Research (COCR)
London, E1 2AD
Rinat Erza, PhD, 0207 882 6348, r.ezra@qmul.ac.uk
Nikolaos Gkranias, DDS, PhD, n.gkranias@qmul.ac.uk
- Recruiting
St Bartholomew's Hospital, Barts Health NHS Trust
London
Anjali Zalin, Dr
- Recruiting
Luton and Dunstable University Hospital
Luton
Anjali Zalin, Dr
About this study
Official title: 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.
Read the 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.
- Conditions
- Bariatric Surgery Candidate, Obesity
- Medical subject headings
- Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Periodontal Disease in an Obese Population
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.
Measured: 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 outcomes (3)
Investigation of inflammatory biomarkers that have been previously been associated with Periodontal Disease in the saliva of obese patients.
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.
Measured: 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
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.
Measured: 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.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2021
- Study start31 Jan 2014
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric Surgery CandidateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 394 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Collaborators
- University College London Hospitals
- Responsible party
- Sponsor
- Investigators
- Nikolaos Donos, Prof., Principal investigator, Professor of Periodontology and Implantology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04851470
- Sponsor's protocol ID
- IRAS ID 108243
- Acronym
- Bariatric
- Status last verified
- Jul 2026
- First submitted
- 8 Mar 2021
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No