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
- Are there results?
- Not yet: the study is under way
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.
- More trials run by Queen Mary University of LondonThe sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Periodontal Assessment of a Bariatric Care Population, Clinical, Genetic and Microbiological Characteristics. A Cross-sectional Study.
- ClinicalTrials.gov ID
- NCT04851470
- Acronym / sponsor ID
- Bariatric / IRAS ID 108243
- Conditions
- Bariatric Surgery Candidate, Obesity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 394 participants (estimated)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Collaborators
- University College London Hospitals
- Study start
- 31 Jan 2014 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 20 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nikolaos Donos, Prof. principal investigator
Professor of Periodontology and Implantology
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bariatric Surgery Candidate and Obesity, run by Queen Mary University of London at 4 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vandana Luthra, Dr. (02078826348, BHNT.Clinicaloralresearchcentre@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026; AzTrials last refreshed its copy on 8 Nov 2026.