Periodontal Assessment of a Bariatric Care Population
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Bariatric Surgery Candidate, Obesity. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Periodontal Assessment of a Bariatric Care Population, Clinical, Genetic and Microbiological Characteristics. A Cross-sectional Study.
Overview
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.
Primary outcome measures
- 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.]
Secondary outcome measures (3)
- 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.]
Eligibility criteria
Inclusion criteria
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.
Exclusion criteria
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.
- 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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United Kingdom · 4 centers
- Barts Health NHS Trust Dental Hospital — London
- Centre for Oral Clinical Research (COCR) — London
- St Bartholomew's Hospital, Barts Health NHS Trust — London
- Luton and Dunstable University Hospital — Luton
Identifiers
NCT: NCT04851470 · IRAS ID 108243