Periodontal Assessment of a Bariatric Care Population

Obesity Clinical Trial

— Bariatric  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04851470
• Other study ID #: IRAS ID 108243
• Status: Active, not recruiting
• Start date: January 31, 2014
• Est. completion date: February 1, 2025

Study information

• Verified date: May 2023
• Source: Queen Mary University of London
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 394
• Est. completion date: February 1, 2025
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Obesity

Locations

Country	Name	City	State
United Kingdom	Barts Health NHS Trust Dental Hospital	London
United Kingdom	Centre for Oral Clinical Research (COCR)	London

Sponsors (2)

Lead Sponsor	Collaborator
Queen Mary University of London	University College London Hospitals

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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	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.	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.
Secondary	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.	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.
Secondary	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.	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.