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Clinical Trials in France / NCT06012019
Recruiting Observational

Periodontitis and Inflammation: Study on Biological Samples

NCT06012019 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2025-04-30
Last updated
2025-08-24

Condition(s) studied

Periodontitis

Investigational drug(s) / intervention(s)

Biological sampling in Periodontitis CaseBiological sampling in Gingivitis CaseBiological sampling in Control Case

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

Biological sampling in Gingivitis Case: 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

Biological sampling in Control Case: 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

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: 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 Exclusion Criteria: * Patients who have received antibiotic prophylaxis, antibiotic therapy, or anti-inflammatory treatment within 3 months prior to inclusion * 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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Charles-Foix Hospital Ivry-sur-Seine France Recruiting

More Assistance Publique - Hôpitaux de Paris trials in France

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06012019 on ClinicalTrials.gov ↗ ← All trials in France