Understanding the links between periodontitis, inflammation, and diabetes
Characterization of the Immuno-inflammatory Response Involved in Bone Destruction During Periodontitis: Study With Biological Collection
This study is trying to understand how periodontitis and inflammation are connected to diabetes by looking at biological samples from patients with severe gum disease and healthy people.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 219 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 2 sites (Ivry-sur-Seine and 1 other locations) |
| Trial ID | NCT04831060 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the pathogenic mechanisms involved in periodontitis and peri-implantitis by characterizing specific molecular markers that reflect the activity of these conditions. Biological samples such as plaque, saliva, and crevicular fluid will be collected from patients with advanced stages of periodontitis or peri-implantitis, as well as from healthy individuals. The study seeks to improve knowledge of the disease's pathogenesis, identify target molecules involved in tissue destruction, and determine molecular profiles of patients at risk. This research is non-interventional and will be conducted across multiple centers as part of routine care.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with stage 3 or 4 periodontitis or peri-implantitis, as well as healthy individuals requiring dental care.
Not a fit: Patients with no history of periodontitis or peri-implantitis and who do not require dental treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved prevention and treatment strategies for periodontitis and peri-implantitis.
How similar studies have performed: Other studies have shown success in identifying biomarkers for periodontal diseases, making this approach promising yet still requiring further exploration.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Ivry-sur-Seine and 1 other locations
- Service d'odontologie, hôpital Charles Foix — Ivry-sur-Seine, France (Recruiting)
- Dentistry department- Rothschild hospital — Paris, France (Recruiting)
Study contacts
- Study coordinator: Marjolaine GOSSET, Professor
- Email: marjolaine.gosset@aphp.fr
- Phone: +33 6 19 39 39 01
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.