NCT06012019 Periodontitis and Inflammation: Study on Biological Samples
| NCT ID | NCT06012019 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Periodontitis |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-04-30 |
| Primary Completion | 2028-05-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2025-04-30 with a primary completion date of 2028-05-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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. 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 Criteria
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.
Contact & Investigator
Marjolaine Gosset, PU-PH
PRINCIPAL INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Frequently Asked Questions
Who can join the NCT06012019 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Periodontitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06012019 currently recruiting?
Yes, NCT06012019 is actively recruiting participants. Contact the research team at marjolaine.gosset@u-paris.fr for enrollment information.
Where is the NCT06012019 trial being conducted?
This trial is being conducted at Ivry-sur-Seine, France.
Who is sponsoring the NCT06012019 clinical trial?
NCT06012019 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Marjolaine Gosset, PU-PH at Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 60 participants.