NCT04851470 Periodontal Assessment of a Bariatric Care Population
| NCT ID | NCT04851470 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Queen Mary University of London |
| Condition | Bariatric Surgery Candidate |
| Study Type | OBSERVATIONAL |
| Enrollment | 394 participants |
| Start Date | 2014-01-31 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 394 participants in total. It began in 2014-01-31 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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).
Contact & Investigator
Nikolaos Donos, Prof.
PRINCIPAL INVESTIGATOR
Professor of Periodontology and Implantology
Frequently Asked Questions
Who can join the NCT04851470 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Bariatric Surgery Candidate. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04851470 currently recruiting?
Yes, NCT04851470 is actively recruiting participants. Contact the research team at BHNT.Clinicaloralresearchcentre@nhs.net for enrollment information.
Where is the NCT04851470 trial being conducted?
This trial is being conducted at London, United Kingdom, London, United Kingdom, London, United Kingdom, Luton, United Kingdom.
Who is sponsoring the NCT04851470 clinical trial?
NCT04851470 is sponsored by Queen Mary University of London. The principal investigator is Nikolaos Donos, Prof. at Professor of Periodontology and Implantology. The trial plans to enroll 394 participants.