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Periodontal Assessment of a Bariatric Care Population

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04851470
Acronym
Bariatric
Enrollment
394
Registered
2021-04-20
Start date
2014-01-31
Completion date
2027-12-31
Last updated
2026-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bariatric Surgery Candidate, Obesity

Brief 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. 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.

Interventions

None listed

Sponsors

Queen Mary University of London
Lead SponsorOTHER
University College London Hospitals
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of Periodontal Disease in an Obese PopulationCross-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.

Secondary

MeasureTime frameDescription
Investigation of inflammatory biomarkers that have been previously been associated with Periodontal Disease in the saliva of obese 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.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.
Correlation of FTO gene (Obesity) polymorphisms with the prevalence of PD in obese populationCross-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.
Correlation of subgingival microbial flora in obese patients with and without periodontitis.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.

Countries

United Kingdom

Contacts

CONTACTVandana Luthra, Dr.
BHNT.Clinicaloralresearchcentre@nhs.net02078826348
PRINCIPAL_INVESTIGATORNikolaos Donos, Prof.

Professor of Periodontology and Implantology

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 3, 2026