Assessing gum disease in obese patients preparing for weight loss surgery
Periodontal Assessment of a Bariatric Care Population, Clinical, Genetic and Microbiological Characteristics. A Cross-sectional Study.
This study looks at how common and serious gum disease is in obese people getting ready for weight loss surgery and checks if there's a link between gum health and certain genes or inflammation in their saliva.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 394 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Queen Mary University of London Academic / other |
| Locations | 4 sites (London and 3 other locations) |
| Trial ID | NCT04851470 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the prevalence and severity of periodontal disease in obese individuals who are candidates for bariatric surgery. It will also explore the relationship between inflammatory biomarkers in saliva and periodontal disease, as well as the association of FTO gene polymorphisms with periodontal health. Participants will undergo a medical examination and periodontal assessments as part of their routine care at the UCLH bariatric clinic. Data collected will include demographic information, body composition, and genetic samples when applicable.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with a BMI of 30 kg/m2 or higher who are preparing for bariatric surgery.
Not a fit: Patients who are completely edentulous or have uncontrolled systemic illnesses may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of the oral health challenges faced by obese patients and improve pre-surgical assessments.
How similar studies have performed: While the specific focus on periodontal disease in bariatric candidates may be novel, studies have shown associations between obesity and oral health issues, indicating potential relevance.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
London and 3 other locations
- Barts Health NHS Trust Dental Hospital — London, United Kingdom (Recruiting)
- Centre for Oral Clinical Research (COCR) — London, United Kingdom (Recruiting)
- St Bartholomew's Hospital, Barts Health NHS Trust — London, United Kingdom (Recruiting)
- Luton and Dunstable University Hospital — Luton, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Nikolaos Donos, Prof. — Professor of Periodontology and Implantology
- Study coordinator: Vandana Luthra, Dr.
- Email: BHNT.Clinicaloralresearchcentre@nhs.net
- Phone: 02078826348
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.