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NCT Number: NCT06781229

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of Toulouse

Toulouse, France

Location status: Recruiting

About this study

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

  • 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).
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • BMI greater than or equal to 30
  • 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

  • Alcohol consumption >30g/d (men) or 20g/d (women),
  • 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

Treatment and study plan

Primary outcomes

  1. Taxonomic analysis

    Time frame: before bariatric surgery

    Taxonomic analysis of the microbiological composition of the periodontal plaque between group 1 (obesity) and 2 (morbid obesity) : relative quantities of periodontal bacteria between group 1 (obesity) and 2 (morbid obesity)

Study contacts

Contact information is provided by the study sponsor or research team.

Stephanie BRAYER, Clinical Trial Assistant, master's degree

CONTACT

[email protected]

0561322509

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

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

Acronym: OROBESITE

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jan 17, 2025
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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