Relationship Between Porphyromonas Gingivalis and Obesity in Patients With Periodontitis (PAROBIOTA)

Non-interventional Study Exploring the Relationship Between Porphyromonas Gingivalis and Obesity in Patients With Periodontitis

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Estimated): 311

Contacts and Locations

• Study Contact: Name: Sara LAURENCIN, MD; Phone Number: +33 0561344473; Email: laurencin.s@chu-toulouse.fr
• Study Contact Backup: Name: Cathy NABET, Pr; Email: catherine.nabet@univ-tlse3.fr

Study Locations

• France
  • Toulouse, France, 31059
    • Recruiting
    • UHToulouse
    • Contact: Sara LAURENCIN; Phone Number: +33561777051; Email: olivier.i@chu-toulouse.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

any patient coming for consultation in the periodontology department

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analysis by bacterial culture and taxonomic analysis (MiSEQ) of the microbiological composition of saliva	Assess the microbiological composition of saliva and periodontal plaque in obese (BMI≥30) and non-obese (BMI<30) patients with periodontitis.	8 weeks
Analysis by bacterial culture and taxonomic analysis (MiSEQ) of the microbiological composition periodontal plaque	Assess the microbiological composition of periodontal plaque in obese (BMI≥30) and non-obese (BMI<30) patients with periodontitis.	8 weeks

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2022
• Primary Completion (Estimated): March 27, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: December 5, 2022
• First Submitted That Met QC Criteria: July 5, 2023
• First Posted (Actual): July 12, 2023

Study Record Updates

• Last Update Posted (Actual): July 12, 2023
• Last Update Submitted That Met QC Criteria: July 5, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Obesity; Periodontitis
• Other Study ID Numbers: RC31/20/0478

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No