Periodontitis and Inflammation

NCT ID: NCT04831060

Last Updated: 2026-01-21

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 219 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-02-15
• Study Completion Date: 2028-11-15

Brief 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).

Detailed Description

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

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.

Conditions

Periodontitis; Peri-Implantitis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Case Periodontitis

Patients with stage 3 or 4 periodontitis

Periodontal or peri-implantitis treatment

Intervention Type: PROCEDURE

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

Case peri-implantitis

Patients should present at least 1 implant with peri-implantitis

Periodontal or peri-implantitis treatment

Intervention Type: PROCEDURE

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 (healthy periodontium)

Patients with gingival health on intact or reduced periodontium without a history of periodontitis or peri-implantitis and requiring surgical care such as dental avulsion or pre-prosthetic periodontal surgeries or aesthetic surgeries

Control treatment

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: 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

Intervention Type: PROCEDURE

Other Intervention Names

Scaling and root planning; periodontal debridement; periodontal or peri-implantal surgery; open flap debridement; gingivectomy; crown lengthening; periodontal plastic surgery; pre-prosthetic periodontal surgery

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Service d'odontologie, hôpital Charles Foix

Ivry-sur-Seine, , France

Site Status: RECRUITING

Dentistry department- Rothschild hospital

Paris, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Marjolaine GOSSET, Professor

Role: CONTACT

marjolaine.gosset@aphp.fr

+33 6 19 39 39 01

Facility Contacts

Marjolaine GOSSET, MD,PhD

Role: primary

marjolaine.gosset@aphp.fr

01 49 59 48 11 ext. +33

Marjolaine GOSSET, MD,PhD

Role: primary

marjoilaine.gosset@aphp.fr

Other Identifiers

APHP200784

Identifier Type: -

Identifier Source: org_study_id