Periodontal Microbiota of Patients Candidates for Bariatric Surgery with Body Mass Index Greater Than 30
NCT ID: NCT06781229
Last Updated: 2025-01-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
170 participants
OBSERVATIONAL
2025-03-01
2029-03-01
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Group 1 : obesity : 30 ≤ BMI < 35
Obese patients with 30 ≤ BMI \< 35
No interventions assigned to this group
Group 2 : morbid obesity : 35 ≤ BMI
Morbid obese patients with 35 ≤ BMI
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Be on the list of patients scheduled for bariatric surgery,
* Be able to receive information about the study and understand the information form in order to take part in the study. This implies mastering the French language,
Exclusion Criteria
* Having taken antibiotics, prebiotics or probiotics in the month prior to inclusion (this has an influence on the composition of the patient's microbiota),
* During pregnancy or breastfeeding,
* For whom oral surgery is planned (surgery for benign or malignant tumours of the maxillary and mandibular bone bases), or with a history of oral surgery in the month prior to inclusion,
* At risk of infection (existence of one or more of the following known chronic infectious diseases: HIV, HBV, HCV and mononucleosis) and/or chronic renal insufficiency (creatinine clearance \< 60ml/min),
* Patients with a general pathology that contraindicates the performance of diagnostic procedures such as periodontal probing (patients at high risk of infective endocarditis according to the ANSM).
* Totally edentulous patients
18 Years
ALL
No
Sponsors
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University Hospital, Toulouse
OTHER
Responsible Party
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Central Contacts
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Stephanie BRAYER, Clinical Trial Assistant, master's degree
Role: CONTACT
Other Identifiers
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RC31/24/0432
Identifier Type: -
Identifier Source: org_study_id
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