NCT06781229

Periodontal Microbiota of Patients Candidates for Bariatric Surgery with Body Mass Index Greater Than 30

Non-interventional Study Exploring the Composition of the Periodontal Microbiota of Patients with Body Mass Index Greater Than 30 That Are Candidates for Bariatric Surgery

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 170 (estimated)
• Sponsor: University Hospital, Toulouse · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this observational study is to compare the microbiological composition of the periodontal plaque of obese people undergoing bariatric surgery according to their Body Mass Index. The main question it aims to answer is: Does obese patients have different microbiote according to their obesity? Obesity being classified in two groups : * group "obesity" for a BMI between 30 and 35 * versus "morbid obesity" group with a BMIabove 35. Participants who are scheduled to undergo bariatric surgery as part of their regular medical care will answer questions about their quality of life, hygiene habits, and saliva and periodontal samples will be taken.

Detailed description

The study is a non-interventional, single-centre, cross-sectional, comparative study with prospective and consecutive recruitment of participants. Participants who are scheduled to undergo bariatric surgery as part of their regular medical care will 1. during the odontological visit of approximately one hour: * complete standard odontology medical questionnaire * complete the dietary hygiene questionnaire: "Etude Nationale Nutrition Santé" questionnaire * complete 2 quality of life questionnaires: EQ-5D-5L questionnaire and GOHAI self-questionnaire * undergo clinical examination (visual examination and partial periodontal probing), * Radiological check-up (panoramic X-ray) and biological check-up (salivary and periodontal samples (non-invasive). 2. During bariatric surgery, surgical techniques create surgical waste. From this operative waste, fragments of visceral adipose tissue may be recovered and, if the surgery so requires, subcutaneous adipose tissue (quantity recovered: 5g of visceral adipose tissue and 5g of subcutaneous adipose tissue). The samples taken will be stored in a hospital tissue bank with a view to possible future re-use. Each patient will be informed of this during the inclusion visit.

Conditions

• Bariatric Surgery
• Obesity, Morbid

Timeline

• Start date: 2025-03-01
• Primary completion: 2029-03-01
• Completion: 2029-03-01
• First posted: 2025-01-17
• Last updated: 2025-01-17