Periodontitis and Inflammation

Periodontitis Clinical Trial

— CB-PARO  

Official title:

Characterization of the Immuno-inflammatory Response Involved in Bone Destruction During Periodontitis: Study With Biological Collection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04831060
• Other study ID #: APHP200784
• Status: Recruiting
• Start date: February 15, 2023
• Est. completion date: November 15, 2025

Study information

• Verified date: October 2022
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Marjolaine GOSSET, Professor
• Phone: +33 6 19 39 39 01
• Email: marjolaine.gosset[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Today, to understand pathogenic mechanisms involved in periodontitis remains a challenge to identify biomarkers or therapeutic targets to improve prevention and screening, as well as the effectiveness of periodontitis 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;

• 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 stage 3 or 4 versus patients with a healthy periodontium. Biological samples will be collected before and all along the periodontal 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 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 versus without periodontitis 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).

Description:

Today, to understand pathogenic mechanisms involved in periodontitis remains a challenge to identify biomarkers or therapeutic targets to improve prevention and screening, as well as the effectiveness of periodontitis 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;

• 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. 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 UR2496 for their analysis.

Patients will be recruited in the oral medicine departments of AP-HP hospitals (Charles Foix (Ivry/seine) and Henri Mondor (Créteil)) by periodontists in two groups (cases = periodontitis 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 12 months. There is no specific follow-up due to the research.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: November 15, 2025
• Est. primary completion date: November 15, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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: 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

-Control group: Patient 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.)

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

Related Conditions & MeSH terms

• Periodontitis

Intervention

Procedure:
• Periodontal treatment
For Cases : Inclusion; Periodontal bacteria, gingival fluid and unstimulated saliva collection; Teaching of oral hygiene techniques. Non-surgical periodontal treatment At 3 months = periodontal reevaluation; Periodontal bacteria, gingival fluid and unstimulated saliva collection If periodontal pockets greater than 5mm and bleeding persist: periodontal surgery and gingival explant sampling At 3 months post-surgery = periodontal re-evaluation; Periodontal bacteria, gingival fluid and unstimulated saliva collection Maintenance For Controls: Inclusion; Periodontal bacteria, gingival fluid and unstimulated saliva collection, teaching of oral hygiene techniques. Plastic or pre-prosthetic surgery = gingival explant sampling Healing control at 15 days

Locations

Country	Name	City	State
France	Service d'odontologie, hôpital Charles Foix	Ivry-sur-Seine

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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- 1a, IL- 1ß, IL-2, IL-4, IL-5, IL-6, IL-8, IL-10, IL-12, IL-13, IL-15, IL-17, IL-18, IFN ?, TNF) simultaneously	1 month once the collection is completed
Secondary	Cytokines expression in periodontal cells	Analysis of cytokines, inflammation pathways and inflammation cells by histological analysis (immunofluorescence) of surgical specimens.	6 months once the collection is completed
Secondary	Cytokines expression in periodontal cells	Immunofluorescence evaluation of protein distribution (inflammatory mediators, inflammatory pathway signaling proteins) in gingival explants (confocal microscopy analysis).	6 months once the collection is completed
Secondary	Microbiological analysis of the subgingival biofilm determination of the percentage of periodontopathogens.	assessment through RT-PCR	3 months once the collection is completed
Secondary	Characterization of proteases (MMP) present in gingival fluid and unstimulated saliva	assessment through Luminex®	1 month once the collection is completed