Clinical trial NCT04851470: Periodontal Assessment of a Bariatric Care Population
Official title: Periodontal Assessment of a Bariatric Care Population, Clinical, Genetic and Microbiological Characteristics. A Cross-sectional Study.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bariatric Surgery Candidate
Obesity
Lead sponsor: Queen Mary University of London
Sponsor class: OTHER
Collaborators: name: University College London Hospitals
First posted: 2021-04-20
Enrollment: 394
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Prevalence of Periodontal Disease in an Obese Population
timeFrame: 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:
measure: Investigation of inflammatory biomarkers that have been previously been associated with Periodontal Disease in the saliva of obese patients.
timeFrame: 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.
measure: Correlation of FTO gene (Obesity) polymorphisms with the prevalence of PD in obese population
timeFrame: 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.
measure: Correlation of subgingival microbial flora in obese patients with and without periodontitis.
timeFrame: 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.
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Barts Health NHS Trust Dental Hospital
city: London
country: United Kingdom
facility: Centre for Oral Clinical Research (COCR)
city: London
country: United Kingdom
facility: St Bartholomew's Hospital, Barts Health NHS Trust
city: Luton
country: United Kingdom
facility: Luton and Dunstable University Hospital
Study officials:
affiliation: Professor of Periodontology and Implantology
name: Nikolaos Donos, Prof.
role: PRINCIPAL_INVESTIGATOR
References: