Immunological and clinical evaluation of the causes of peri-implantitis
Official title: Immunological-Clinical Evaluation of the Etiopathogenesis of Peri-Implantitis
Run by Wroclaw Medical University · NCT07012915 · Data updated 2026-11-12
This project will see if blood tests can reveal immune reactions or metal-related signals in adults with advanced peri-implantitis.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Wroclaw Medical University Academic / other |
| Locations | 1 site (Wroclaw, Lower Silesian Voivodeship) |
| Status | Recruiting |
| Started | July 1, 2025 |
| Main results expected | April 1, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | July 10, 2025 |
| Trial ID | NCT07012915 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with active, advanced peri-implantitis (pocket depth >6 mm, positive BoP, and >66% bone loss at an implant) who can attend one of the participating European centers and are not pregnant or taking antiresorptive medications are ideal candidates.
✕Probably not a fit
People with mild or stable peri-implant conditions, pregnant individuals, or those with a history of bisphosphonate or other antiresorptive use or surgical contraindications are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
An international consortium will recruit 100 adults with advanced peri-implantitis (20 per partner site) to collect clinical data and blood samples at five European university centers. Eligible participants must have pocket depths >6 mm, positive bleeding on probing, and bone loss exceeding 66% on at least one implant surface. Collected blood will be analyzed for immunological markers and levels of titanium or other metal ions to compare two leading theories of peri-implantitis origin: bacterial invasion versus an immune reaction to metallic particles. Each partner site will obtain local ethics approval and perform procedures at its clinical facility.
Why it matters
Potential benefit: If successful, the project could identify blood markers or metal signals that help guide diagnosis, prevention, or personalized treatment for peri-implantitis.
How similar studies have gone: Prior research has reported local immune responses and titanium particle associations with peri-implantitis, but clinical evidence from blood-based multicenter studies is limited, making this consortium approach relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * PD (Pocket Depth) at the implant site exceeds 6mm, * Positive BoP (Bleeding on Probing) index * Bone loss exceeding 66% on at least one implant surface Exclusion Criteria: * General and local contraindications for surgical procedures * Pregnancy * Use of bisphosphonates or other antiresorptive medications in medical history
Where it's running
-
Oral Surgery Department Wroclaw Medical University
Wroclaw, Lower Silesian Voivodeship, Poland Recruiting
Study contacts
- Study coordinator: Pawel Kubasiewicz-Ross, PhD, DDS
- Email: pawel.kubasiewicz-ross@umw.edu.pl
- Phone: 504075920
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.