Periodontitis and Inflammation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris
About this trial
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
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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.
Trial population
This study concerns adult patients consulting the oral medicine departments of Hôpital Charles Foix (AP-HP, Ivry sur Seine) and Hôpital Rothschild (AP-HP, Paris) - Patients: Patients should have: \- localized or generalized periodontitis of stage 3 or 4. The diagnosis of periodontitis is based on the elements noted during the interview and the clinical examination. Or * at least 1 implant with peri-implantitis. The diagnosis is based on the findings of the interview, clinical examination and radiographic examination. * Controls: Patients with gingival health on intact or reduced periodontium with no history of periodontitis and requiring surgical care such as dental avulsion and pre-prosthetic periodontal corrective/aesthetic surgeries (coronal elongation, neck alignment
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Periodontal or peri-implantitis treatment
Procedure/SurgeryFor 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
Procedure/SurgeryFor 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
Treatment groups
219 Participants
are divided into 3 treatment groupsGroup A: Case Periodontitis1 intervention
Group B: Case peri-implantitis1 intervention
Group C: Control (healthy periodontium)1 intervention
Trial outcomes
Primary outcomes
1
Characterization of a panel of cytokines in gingival fluid of patients with periodontitis versus without periodontitis
Analysis of gingival fluids and unstimulated saliva by the Luminex allows detection and quantification of 15 cytokines (IL- 1α, IL- 1β, IL-2, IL-4, IL-5, IL-6, IL-8, IL-10, IL-12, IL-13, IL-15, IL-17, IL-18, IFN γ, TNF) simultaneously
Time frame
1 month once the collection is completedSecondary outcomes
1
Cytokines expression in periodontal cells
Analysis of cytokines, inflammation pathways and inflammation cells by histological analysis (immunofluorescence) of surgical specimens.
Time frame
6 months once the collection is completed2
Cytokines expression in periodontal cells
Immunofluorescence evaluation of protein distribution (inflammatory mediators, inflammatory pathway signaling proteins) in gingival explants (confocal microscopy analysis).
Time frame
6 months once the collection is completed3
Microbiological analysis of the subgingival biofilm determination of the percentage of periodontopathogens.
assessment through RT-PCR
Time frame
3 months once the collection is completed4
Characterization of proteases (MMP) present in gingival fluid and unstimulated saliva
assessment through Luminex®
Time frame
1 month once the collection is completedSponsors and contacts
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Source ClinicalTrials.gov