Periodontitis and Inflammation: Study on Biological Samples

NCT06012019 | Recruiting DMC

• 1 other identifier: APHP230385
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Periodontitis is a major public health problem because it is widespread in the adult population. It leads to the irreversible destruction of the anchoring tissues of the teeth, and represents a modifiable risk factor for systemic inflammatory pathologies. This chronic inflammatory disease, which is associated with oral dysbiosis involving Porphyromonas gingivalis, is triggered by a permissive immune response. It is preceded by a reversible clinical phase, during which there is no bone resorption process: gingivitis. The understanding of the key mechanisms involved in the evolution from gingivitis to periodontitis, which will allow to early identify patient at risk of periodontitis, remain unclear at this time. Neutrophils are the main cells of inflammation present within the periodontal pockets. The excess of certain neutrophils or the alteration of their functions is associated with the triggering of periodontitis, whereas their activity, finely orchestrated, would be a key to periodontal homeostasis. It is likely that some periodontal bacteria, including P. gingivalis, but also products of matrix catabolism could deregulate the physiological functions of neutrophils towards pro-inflammatory and catabolic profiles. Moreover, to date, the differentiation and role of neutrophil subsets in periodontal homeostasis as well as in gingivitis and its evolution into periodontitis remain poorly studied. The investigators hypothesize that various subsets of neutrophils may play different roles during the development of periodontitis (evolution of gingivitis to periodontitis). The primary objective is to characterize neutrophil subtypes associated with periodontal destruction during periodontitis. Secondary objectives are :

1. 1.Identify specific interactions of tissue-activated neutrophils with the matrix microenvironment during periodontitis
2. 2.Identify specific interactions of tissue or oral (salivary) activated neutrophils with the oral microbiota during periodontitis
3. 3.Identify specific oral (salivary) neutrophil subtypes in periodontal health, gingivitis and periodontitis
4. 4.Evaluate the function, including pro-osteoclastogenic function, of oral neutrophils compared to blood neutrophils stimulated by infection

Conditions

Periodontitis

Keywords

Periodontitis; Gingivitis; Neutrophils; Subsets; Biological collection

Outcome Measures

Primary Outcomes (1)

• Description of neutrophil subtypes associated with periodontal destruction in periodontitis based on coexpression of markers of neutrophil function .

  Distinction of neutrophil subtypes based on coexpression of markers of neutrophil function from a panel of 24 markers by imaging on tissue sections

  36 months

Secondary Outcomes (7)

• Identify specific interactions of activated tissue neutrophils with the matrix microenvironment during periodontitis using Immunohistofluorescence identification of the expression of some matrix proteins.

  36 months

• Identify interactions of activated tissue or oral neutrophils with the oral microbiota using Immunohistofluorescence identification of key bacteria and investigation of co-localization between bacteria and certain subtypes of neutrophils

  36 months

• Describe oral (salivary) neutrophil subtypes during periodontal health, gingivitis and periodontitis based on coexpression of markers of neutrophil function.

  36 months

• Evaluate the differenciation, particularly proosteoclastogenic, of oral neutrophils, in comparison with blood neutrophils, stimulated by infection using morphological criteria like the number of nuclei and cell size

  36 months

• Evaluate the differenciation, particularly proosteoclastogenic, of oral neutrophils, in comparison with blood neutrophils, stimulated by infection using morphological criteria like the cell size

  36 months

Study Arms (3)

Periodontitis Cases

Patients with stage 3 or 4 periodontitis (Chicago 2017) ; BOP ≥ 10%, PD≥ 4mm Patients requiring surgical care such as dental avulsion or pre-prosthetic periodontal surgeries

Other: Biological sampling in Periodontitis Case

Gingivitis Cases

BOP ≥ 10%, PD≤ 3mm according to Chicago 2017 Patients requiring surgical care such as dental avulsion or pre-prosthetic periodontal surgeries

Other: Biological sampling in Gingivitis Case

Control

BOP \< 10%, PD≤ 3mm Patients with gingival health on intact or reduced periodontium without a history of periodontitis and requiring surgical care such as dental avulsion or aesthetic surgeries

Other: Biological sampling in Control Case

Interventions

Biological sampling in Periodontitis Case OTHER

Periodontal bacteria, gingival fluid, unstimulated saliva and blood collection; J+7 : tooth extraction : gingival explant sampling J+15 : Healing control

Periodontitis Cases

Biological sampling in Gingivitis Case OTHER

Periodontal bacteria, gingival fluid, unstimulated saliva and blood collection; J+7 : tooth extraction or pre-prosthetic periodontal surgeries : gingival explant sampling J+15 : Healing control

Gingivitis Cases

Biological sampling in Control Case OTHER

Periodontal bacteria, gingival fluid, unstimulated saliva and blood collection; J+7 : tooth extraction or pre-prosthetic periodontal surgeries : gingival explant sampling J+15 : Healing control

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study concerns adult patients consulting the oral medicine department at Hôpital Charles Foix (AP-HP, Ivry sur Seine) Cases : * Group 1 = Patients should have bacterial gingivitis * Group 2 = Patients should have stage 3 or 4 localized or generalized bacterial periodontitis. The diagnosis of gingivitis or periodontitis is based on the elements noted during the clinical interview and examination, in accordance with the Chicago 2017 classification. Control: Patient with healthy gingiva on intact or reduced periodontium with no history of periodontitis, in accordance with the Chicago 2017 classification.

You may qualify if:

• Common criteria for all patient groups
• Patient \> 18 years old
• Patient affiliated to a national health insurance
• Patient who speaks and understands French well enough to be able to read and understand the study information note.
• Patient who does not object to his participation in the study
• Specific Criteria :
• Control Group = BOP \< 10%, PI\<20%, PD≤ 3mm
• Gingivitis cases = BOP ≥ 10%, PD≤ 3mm
• Periodontitis cases = BOP ≥ 10%, PD\> 3mm

You may not qualify if:

• Pregnant or breastfeeding women
• Patients suffering from a disease with defective neutrophil number, activity, activation or function
• Patient deprived of liberty by judicial or administrative decision.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Charles-Foix Hospital

Ivry-sur-Seine, 94200, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

gingival tissue and fluid, saliva and serum samples

MeSH Terms

Conditions

Periodontitis; Gingivitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases

Study Officials

• Marjolaine Gosset, PU-PH

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marjolaine Gosset, PU-PH

CONTACT

01 49 59 48 11; marjolaine.gosset@u-paris.fr

François Ferré, MCU-PH

CONTACT

01 49 59 48 11; françois.ferre@aphp.fr

Study Design

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

Study Record Dates

• First Submitted: June 30, 2023
• First Posted: August 25, 2023
• Study Start: April 30, 2025
• Primary Completion (Estimated): May 15, 2028
• Study Completion (Estimated): May 15, 2028
• Last Updated: August 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
• Access Criteria: Researchers who provide a methodologically sound proposal

Locations

FR (1)