PAROBIOTA: Relationship Between Porphyromonas Gingivalis and Obesity in Patients With Periodontitis

Sponsor
University Hospital, Toulouse (Other)
Overall Status
Recruiting
CT.gov ID
NCT05942703
Collaborator
(none)
311
1
24.8
12.5

Study Details

Study Description

Brief Summary

Obesity is recognized as a major public health problem. Recent research suggests the involvement of the gut microbiota in the development of obesity. Indeed, obese people are characterized by a dysbiotic intestinal microbiota. Periodontitis are chronic inflammatory oral pathologies linked to an imbalance between the bacterial etiological factor, oral dysbiosis, and the host's immune defenses.They lead to the destruction of the supporting tissues of the tooth and an apical migration of the periodontal attachment system, thus leading to the formation of the pathognomonic entity of the disease, the periodontal pocket.the presence of bacteria of oral origin such as Porphyromonas gingivalis (Pg) has been demonstrated in the adipose tissue of obese patients inducing a chronic low-grade inflammatory response by macrophages which leads to the proliferation of adipocyte precursors predisposing to obesity. The main objective is to assess the average amount of Porphyromonas gingivalis (Pg) in the saliva of obese people (BMI ≥ 30) with periodontitis.

Condition or Disease Intervention/Treatment Phase
  • Other: saliva samples

Detailed Description

Obesity is recognized as a major public health problem. Recent research suggests the involvement of the gut microbiota in the development of obesity. Indeed, obese people are characterized by a dysbiotic intestinal microbiota. Periodontitis are chronic inflammatory oral pathologies linked to an imbalance between the bacterial etiological factor, oral dysbiosis, and the host's immune defenses.They lead to the destruction of the supporting tissues of the tooth and an apical migration of the periodontal attachment system, thus leading to the formation of the pathognomonic entity of the disease, the periodontal pocket.the presence of bacteria of oral origin such as Porphyromonas gingivalis (Pg) has been demonstrated in the adipose tissue of obese patients inducing a chronic low-grade inflammatory response by macrophages which leads to the proliferation of adipocyte precursors predisposing to obesity. The main objective is to assess the average amount of Porphyromonas gingivalis (Pg) in the saliva of obese people (BMI ≥ 30) with periodontitis.This study is a comparative cross-sectional non-interventional study with retrospective and prospective and consecutive recruitment of participants.

Prospective patient recruitment:

During the patient's visit to the periodontology department, if the patient has periodontitis and has given his non-objection, he will be included in the study. A routine check-up in odontology will then be carried out: complete medical questionnaire (general, hygiene and dietetics), clinical examination (visual examination and statement of periodontal indices), radiological examination. Samples of saliva and periodontal plaque, conventionally taken in current dental surgery practice in the periodontal management of patients, will be used to carry out bacterial assays. CThe saliva samples, which are part of the usual treatment, will be carried out before and after the non-surgical periodontal treatment.

Study Design

Study Type:
Observational
Anticipated Enrollment :
311 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Non-interventional Study Exploring the Relationship Between Porphyromonas Gingivalis and Obesity in Patients With Periodontitis
Actual Study Start Date :
Dec 5, 2022
Anticipated Primary Completion Date :
Mar 27, 2024
Anticipated Study Completion Date :
Dec 30, 2024

Arms and Interventions

Arm Intervention/Treatment
obese patients

Patients with a body mass index superior or equal at 30 and with a periodontitis

Other: saliva samples
Saliva samples, which are part of the usual treatment, will be carried out before and after the non-surgical periodontal treatment
Other Names:
  • periodontal plaque samples
  • non-obese (BMI<30) patients

    Patients with a body mass index inferior at 30 with a periodontitis

    Other: saliva samples
    Saliva samples, which are part of the usual treatment, will be carried out before and after the non-surgical periodontal treatment
    Other Names:
  • periodontal plaque samples
  • Outcome Measures

    Primary Outcome Measures

    1. Analysis by bacterial culture and taxonomic analysis (MiSEQ) of the microbiological composition of saliva [8 weeks]

      Assess the microbiological composition of saliva and periodontal plaque in obese (BMI≥30) and non-obese (BMI<30) patients with periodontitis.

    2. Analysis by bacterial culture and taxonomic analysis (MiSEQ) of the microbiological composition periodontal plaque [8 weeks]

      Assess the microbiological composition of periodontal plaque in obese (BMI≥30) and non-obese (BMI<30) patients with periodontitis.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • over 18 years old

    • having periodontitis

    • able to receive information on the course of the study and to understand the information form to participate in the study.

    • having given their non-objection to participate in the study

    Exclusion Criteria:
    • Having taken antibiotics, prebiotics or probiotics in the month prior to inclusion

    • During pregnancy or breastfeeding

    • With a history of oral surgery in the month prior to inclusion

    • At risk of infection (existence of one or more known chronic infectious diseases)

    • Suffering from a general pathology contraindicating the performance of diagnostic procedures such as periodontal probing (patients at high risk of infective endocarditis according to the French National Agency for the Safety of Medicines and Products of Health ANSM)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UHToulouse Toulouse France 31059

    Sponsors and Collaborators

    • University Hospital, Toulouse

    Investigators

    • Principal Investigator: Sara LAURENCIN, MD, University Hospital, Toulouse

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Toulouse
    ClinicalTrials.gov Identifier:
    NCT05942703
    Other Study ID Numbers:
    • RC31/20/0478
    First Posted:
    Jul 12, 2023
    Last Update Posted:
    Jul 12, 2023
    Last Verified:
    Jul 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 12, 2023