Periodontitis and Inflammation

NCT04831060 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 219

Last updated 2026-01-21

No results posted yet for this 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).

Conditions

  • Periodontitis
  • Peri-Implantitis

Interventions

PROCEDURE

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

PROCEDURE

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

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-02-15
Primary Completion
2028-11-15
Completion
2028-11-15

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04831060 on ClinicalTrials.gov