Macrophage behavior around dental implants in health and peri-implantitis
Investigation of Macrophage Polarization in Peri-implant Health and Peri-implantitis
Biruni University · NCT07569432
This study will test whether macrophage-related markers in tissue and fluids around dental implants differ between people with peri-implantitis and those with healthy implants, and whether smoking changes those markers.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Biruni University (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Istanbul) |
| Trial ID | NCT07569432 on ClinicalTrials.gov |
What this trial studies
This is an observational study that will collect peri-implant tissue and fluid samples from adults with and without peri-implantitis who are scheduled for implant exposure surgery. Laboratory measurements will include markers related to macrophage polarization (for example, soluble CD163, BAFF and related cytokines) and characterization of pro-inflammatory (M1) versus anti-inflammatory (M2) profiles. The study will compare marker levels between peri-implantitis cases and controls and perform subgroup analyses by smoking status. Results aim to clarify immune patterns at failing implants that might inform future diagnostics or targeted therapies.
Who should consider this trial
Good fit: Adults with at least one bone-level dental implant who meet the 2017 peri-implant disease criteria and are scheduled for exposure surgery are ideal candidates.
Not a fit: Patients with prior peri-implant surgery, uncontrolled systemic disease, recent antibiotic or anti-inflammatory use, pregnancy or contraindications to dental surgery are unlikely to be eligible or to benefit from participation.
Why it matters
Potential benefit: If successful, this could identify immune markers that help guide earlier or more targeted treatments to preserve dental implants.
How similar studies have performed: Prior studies suggest smoking alters macrophage polarization and that markers like sCD163 and BAFF relate to periodontal inflammation, but data specifically linking these markers to peri-implantitis are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Individuals who is suitable for the peri-implantitis diagnosis according to the classifications of periodontal and peri-implant diseases and conditions established in 2017. * Individuals with at least one bone-level dental implant and scheduled to undergo exposure surgery. Exclusion Criteria: * prior peri-implantitis surgery * being diagnosed with autoimmune disease, genetic disorders, bone metabolism disorders, poorly controlled systemic diseases (such as diabetes or hypertension) * pregnancy or lactation * having a history of oral malignancy, chemotherapy or radiotherapy * use of anti-inflammatory drugs within 2 weeks, antibiotics within 3 months, * need for prophylactic antibiotics * contraindications for dental/surgical procedures.
Where this trial is running
Istanbul
- Biruni University — Istanbul, Turkey (Türkiye) (RECRUITING)
Study contacts
- Principal investigator: Ayse Kaban — Biruni University
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.
Conditions: Peri-implantitis, peri-implantitis, smoking, macrophage