Periodontal Assessment of a Bariatric Care Population
Recruiting · NCT04851470 · Observational (researchers observe without assigning treatment)
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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).
Where it is running
4 locations listed.
- Barts Health NHS Trust Dental Hospital - London, United Kingdom
- Centre for Oral Clinical Research (COCR) - London, United Kingdom
- St Bartholomew's Hospital, Barts Health NHS Trust - London, United Kingdom
- Luton and Dunstable University Hospital - Luton, United Kingdom