Immunological and clinical evaluation of the causes of peri-implantitis
Immunological-Clinical Evaluation of the Etiopathogenesis of Peri-Implantitis
This project will see if blood tests can reveal immune reactions or metal-related signals in adults with advanced peri-implantitis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Wroclaw Medical University Academic / other |
| Locations | 1 site (Wroclaw, Lower Silesian Voivodeship) |
| Trial ID | NCT07012915 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Wroclaw, Lower Silesian Voivodeship
- 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
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.