Ignite Creation Date:
2024-05-06 @ 4:03 PM
Last Modification Date:
2024-10-26 @ 2:02 PM
Study NCT ID:
NCT04851470
Status:
RECRUITING
Last Update Posted:
2023-05-30
First Post:
2021-03-08
Brief Title:
Periodontal Assessment of a Bariatric Care Population
Sponsor:
Queen Mary University of London
Organization:
Queen Mary University of London
Study Overview
Official Title:
Periodontal Assessment of a Bariatric Care Population Clinical Genetic and Microbiological Characteristics A Cross-sectional Study
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Bariatric
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None