| NCT ID | NCT04831060 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Periodontitis |
| Study Type | OBSERVATIONAL |
| Enrollment | 219 participants |
| Start Date | 2023-02-15 |
| Primary Completion | 2028-11-15 |
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 219 participants in total. It began in 2023-02-15 with a primary completion date of 2028-11-15.
⚠ 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
Today, to understand pathogenic mechanisms involved in periodontitis and peri-implantitis remains a challenge to identify biomarkers or therapeutic targets to improve prevention and screening, as well as the effectiveness of periodontitis and peri-implantitis treatments. The aim is to characterize, in vivo, specific molecular markers reflecting the activity of the pathology, which could lead to * improve the knowledge of the pathogenesis of periodontitis and peri-implantitis; * determine target molecules involved in tissue destruction; * determine molecular profiles of patients at local and systemic risk; * determine therapeutic targets For this purpose, biological samples will be collected (plaque, saliva, crevicular fluid) from patients with periodontitis or peri-implantitis stage 3 or 4 versus patients with a healthy periodontium. Biological samples will be collected before and all along the periodontal or peri-implantal treatment. Gingiva explants collection will be sampling within the surgical procedures (if they are needed). The primary objective is to investigate tissue and cellular expression of molecular markers associated with periodontal destruction during periodontitis or peri-implantitis in relation to periodontal infection and systemic changes in host response. A characterization of the cytokines in gingival fluid and unstimulated saliva (Luminex® technique) of patients with periodontitis or peri-implantitis versus without periodontitis or peri-implantitis will be done. The secondary objective is to study the influence of periodontitis on systemic pathologies via serum analysis of molecules and bacteria involved in periodontal destruction. Immunofluorescence evaluation of protein expression and distribution (inflammatory mediators, inflammatory pathway signaling proteins) in gingival explants, characterization of proteases (MMP) present in gingival fluid and unstimulated saliva (Luminex® technique) and microbiological analysis of the subgingival biofilm (by quantitative PCR).
Eligibility Criteria
Inclusion Criteria: Common criteria for all patient groups * Patient \> 18 years old * Patient affiliated to a social security system, beneficiary or beneficiary of a right other than AME * 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: \- Case Periodontitis: Patient with localized or generalized periodontitis, stage 3 or 4. The diagnosis of periodontitis is based on the elements found during the interview and clinical examination \- Case peri-implantitis: Patients with at least 1 implant affected by peri-implantitis. Diagnosis is based on the findings of the interview, clinical examination and radiographic examination. Control group: Patient with gingival health on intact or reduced periodontium with no history of periodontitis or peri-implantitis and requiring surgical care such as dental avulsion and pre-prosthetic periodontal corrective/aesthetic surgeries (coronal elongation, neck alignment.) Exclusion Criteria: * Patients who have received antibiotic prophylaxis, antibiotic therapy, or anti-inflammatory treatment within 3 months prior to inclusion * Pregnant or breastfeeding women * Patient included in another interventional research protocol or in a period of exclusion. * Patients under guardianship, curatorship or legal protection. * Patient having expressed his opposition to participate in the research
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04831060 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 NCT04831060 currently recruiting?
Yes, NCT04831060 is actively recruiting participants. Contact the research team at marjolaine.gosset@aphp.fr for enrollment information.
Where is the NCT04831060 trial being conducted?
This trial is being conducted at Ivry-sur-Seine, France, Paris, France.
Who is sponsoring the NCT04831060 clinical trial?
NCT04831060 is sponsored by Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 219 participants.