Periodontal Assessment of a Bariatric Care Population | NCT04851470

Studies
Periodontal Assessment of a Bariatric Care Population

NCT04851470

Sponsor

Queen Mary University of London

Status

Recruiting

Last Update Posted

Jul 2, 2026Actual

Enrollment

394Estimated

Phase

Not provided

Conditions

Bariatric Surgery Candidate
Obesity

Interventions

Not provided

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 31, 2014Actual

Primary Completion Date

Dec 31, 2027Estimated

Completion Date

Dec 31, 2027Estimated

First Submitted Date

Mar 8, 2021

First Submission Date that Met QC Criteria

Apr 15, 2021

First Posted Date

Apr 20, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 1, 2026

Last Update Posted Date

Jul 2, 2026Actual

Name	Class
University College London Hospitals	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

394Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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.

Other Outcomes

Not provided

Eligibility Module

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).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Vandana Luthra, Dr.	Contact	02078826348		BHNT.Clinicaloralresearchcentre@nhs.net

Overall Officials

Name	Affiliation	Role
Nikolaos Donos, Prof.	Professor of Periodontology and Implantology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Barts Health NHS Trust Dental Hospital	Recruiting	London		E1 1BB	United Kingdom

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases