Relationship Between Porphyromonas Gingivalis and Obesity in Patients With Periodontitis

NCT05942703 | Unknown

• 1 other identifier: RC31/20/0478
• Study Type: observational
• Target: 311
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

obese patients

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

Other: saliva samples

non-obese (BMI<30) patients

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

Other: saliva samples

Interventions

saliva samples OTHER

Saliva samples, which are part of the usual treatment, will be carried out before and after the non-surgical periodontal treatment

Also known as: periodontal plaque samples

non-obese (BMI<30) patients; obese patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

any patient coming for consultation in the periodontology department

You may qualify if:

• 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

You may not qualify if:

• During pregnancy or breastfeeding
• 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)

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

UHToulouse

Toulouse, 31059, France

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sara LAURENCIN, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara LAURENCIN, MD

CONTACT

0561344473; laurencin.s@chu-toulouse.fr

Cathy NABET, Pr

CONTACT

catherine.nabet@univ-tlse3.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2022
• First Posted: July 12, 2023
• Study Start: December 5, 2022
• Primary Completion: March 27, 2024
• Study Completion: December 30, 2024
• Last Updated: July 12, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)