Periodontal Assessment of a Bariatric Care Population
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorQueen Mary University of London
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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.
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 outcomes
1
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.
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.2
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.
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.3
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.
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Queen Mary University of London
Lead sponsor
University College London Hospitals
Collaborator
Source ClinicalTrials.gov