Periodontitis and Inflammation

Phase

N/A

Condition

Periodontitis

Treatment

Periodontal or peri-implantitis treatment

Control treatment

Clinical Study ID

NCT04831060

APHP200784

Ages > 18
All Genders
Accepts Healthy Volunteers

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 Criteria

Inclusion

Inclusion Criteria:

Common criteria for all patient groups

Patient > 18 years old
Patient affiliated to a social security system, beneficiary or beneficiary of aright other than AME
Patient who speaks and understands French well enough to be able to read andunderstand 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

The diagnosis of periodontitis is based on the elements found during theinterview and clinical examination

Case peri-implantitis: Patients with at least 1 implant affected byperi-implantitis. Diagnosis is based on the findings of the interview, clinicalexamination 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

Exclusion Criteria:

Patients who have received antibiotic prophylaxis, antibiotic therapy, oranti-inflammatory treatment within 3 months prior to inclusion
Pregnant or breastfeeding women
Patient included in another interventional research protocol or in a period ofexclusion.
Patients under guardianship, curatorship or legal protection.
Patient having expressed his opposition to participate in the research

Study Design

Periodontal or peri-implantitis treatment

February 15, 2023

November 15, 2028

Study Description

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

The research focuses on the characterization of the immuno-inflammatory response involved in periodontitis and peri-implantitis. A characterization of the mediators or cells involved will be performed from biological samples (gingival fluid, unstimulated saliva, gingival explants). The gingival fluid is composed of serum inflammatory exudate and inflammatory mediators produced locally in the periodontal pocket. Unstimulated saliva is a biological fluid composed in part of the gingival fluid that drains into it. It has the advantage of being easier to collect (larger quantity, collection by any health professional).

This is a non-interventional, cross-sectional, multicenter, prospective, open-label, non-randomized study to collect tissue, crevicular, salivary, and serum samples as part of the patient's routine care in oral medicine departments to form a biological collection. The samples and the clinical data of the patients (excel file with anonymized data and locked by a password) will be transferred to UMR1333 for their analysis.

Patients will be recruited in the oral medicine departments of AP-HP hospitals (Charles Foix (Ivry/seine) and Rothschild (Paris) by periodontists in three groups (cases = periodontitis or peri-implantitis and controls = healthy periodontium but patients requiring surgical care).

The time-line of the research is consistent with the usual patient management in oral medicine departments. Inclusion period is 60 months. There is no specific follow-up due to the research.

Gingival tissue sampling during surgery of patients will be performed after their inclusion.

Connect with a study center

Service d'odontologie, hôpital Charles Foix
Ivry-sur-Seine, 94200
France
Active - Recruiting
Dentistry department- Rothschild hospital
Paris, 75012
France
Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.