Periodontal Assessment of a Bariatric Care Population

NCT ID: NCT04851470

Last Updated: 2025-06-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

394 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-31

Study Completion Date

2027-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bariatric Surgery Candidate Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University College London Hospitals

OTHER

Sponsor Role collaborator

Queen Mary University of London

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Nikolaos Donos, Prof.

Role: PRINCIPAL_INVESTIGATOR

Professor of Periodontology and Implantology

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Barts Health NHS Trust Dental Hospital

London, , United Kingdom

Site Status RECRUITING

Centre for Oral Clinical Research (COCR)

London, , United Kingdom

Site Status RECRUITING

St Bartholomew's Hospital, Barts Health NHS Trust

London, , United Kingdom

Site Status RECRUITING

Luton and Dunstable University Hospital

Luton, , United Kingdom

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Vandana Luthra, Dr.

Role: CONTACT

02078826348

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Nikolaos Donos, DDS, MS, FHEA, PhD

Role: primary

+44(0)2078823063

Rinat Ezra Rinat, PhD

Role: backup

+44(0)207 882 6348

Rinat Erza, PhD

Role: primary

0207 882 6348

Nikolaos Gkranias, DDS, PhD

Role: backup

Anjali Zalin, Dr

Role: primary

Anjali Zalin, Dr

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IRAS ID 108243

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Outcomes of Periodontal Regenerative Treatment
NCT04971174 ENROLLING_BY_INVITATION
Imaging Analysis Following Periodontal Surgery
NCT03631693 ACTIVE_NOT_RECRUITING NA