Periodontal Assessment of a Bariatric Care Population

NCT04851470 | Recruiting DMC

• 1 other identifier: IRAS ID 108243
• Study Type: observational
• Target: 394
• Locations: 1 country
• Sites: 4

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.

Conditions

Bariatric Surgery Candidate; Obesity

Outcome Measures

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.

  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 (3)

• 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.

• Correlation of FTO gene (Obesity) polymorphisms with the prevalence of PD in obese population

  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.

  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

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Queen Mary University of London: lead
• University College London Hospitals: collaborator

Study Sites (4)

Barts Health NHS Trust Dental Hospital

London, E1 1BB, United Kingdom

RECRUITING

Centre for Oral Clinical Research (COCR)

London, E1 2AD, United Kingdom

RECRUITING

St Bartholomew's Hospital, Barts Health NHS Trust

London, United Kingdom

RECRUITING

Luton and Dunstable University Hospital

Luton, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Samples of Saliva, Dental bacterial Plaque and Venous Blood

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nikolaos Donos, Prof.

  Professor of Periodontology and Implantology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vandana Luthra, Dr.

CONTACT

02078826348; BHNT.Clinicaloralresearchcentre@nhs.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2021
• First Posted: April 20, 2021
• Study Start: January 31, 2014
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 8, 2025

Record last verified: 2025-06

Locations

GB (4)