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Clinical Trials in France / NCT04831060
Recruiting Observational

Periodontitis and Inflammation

NCT04831060 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2023-02-15
Last updated
2026-01-21

Condition(s) studied

PeriodontitisPeri-Implantitis

Investigational drug(s) / intervention(s)

Periodontal or peri-implantitis treatmentControl treatment

Periodontal or peri-implantitis treatment: For Cases : * Inclusion; Bacterial sampling, gingival fluid and unstimulated saliva collection; Teaching of oral hygiene techniques. * Non-surgical periodontal or peri-implantal treatment * At 3 months = periodontal or peri-implantal reevaluation; Bacterial sampling, gingival fluid and unstimulated saliva collection * If periodontal or peri-implantal pockets greater than 5mm and bleeding persist: surgery and gingival explant sampling * At 3 months post-surgery = periodontal or peri-implantal re-evaluation; Bacterial sampling, gingival fluid and unstimulated saliva collection * Maintenance

Control treatment: For Controls: * Inclusion; Bacterial sampling, gingival fluid and unstimulated saliva collection, teaching of oral hygiene techniques. * Plastic or pre-prosthetic surgery = gingival explant sampling * Healing control at 15 days

Study 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

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 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

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Service d'odontologie, hôpital Charles Foix Ivry-sur-Seine France Recruiting
Dentistry department- Rothschild hospital Paris 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 NCT04831060 on ClinicalTrials.gov ↗ ← All trials in France