Titanium ions form particles that activate and execute interleukin-1β release from lipopolysaccharide-primed macrophages.
M Pettersson, P Kelk, G N Belibasakis...
https://pubmed.ncbi.nlm.nih.gov/26987886/Actively Recruiting
Led by Wroclaw Medical University · Updated on 2025-07-10
100
Participants Needed
1
Research Sites
39 weeks
Total Duration
Researchers are evaluating the causes and immune responses involved in advanced peri-implantitis, a condition affecting dental implants. This international study involves 100 adult volunteers from five European universities and explores two main theories about peri-implantitis development bacterial invasion around implants and an immune reaction triggered by titanium and other metals in the implant. The project also examines how the implant surface changes over time and its effects on surrounding tissues. Each participant will undergo clinical and radiological evaluations, including dental exams, Cone Beam Computed Tomography CBCT scans to measure bone loss and density, and blood tests to analyze inflammation and immune markers. Participants will have their affected implant surgically removed, with tissue samples collected for detailed laboratory analysis of titanium concentration, corrosion, and microscopic surface changes. Follow-up visits are scheduled one week and four weeks after surgery to assess healing, repeat blood tests, and perform additional CBCT scans. During the study, participants will receive medical interviews, oral hygiene and periodontal assessments, and blood sample collections before implant removal and four weeks later. Researchers will measure various blood markers, including inflammatory cytokines, lipid profiles, and vitamin D levels. Implant surfaces will be examined using microscopy and corrosion testing. The study monitors clinical outcomes and biological responses related to peri-implantitis to better understand its development and progression over time.
CONDITIONS
Immunological-Clinical Evaluation of the Etiopathogenesis of Peri-Implantitis
P
Pawel Kubasiewicz-Ross, PhD, DDS
J
Jacek Matys, PhD, DDS
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Wroclaw Medical University
Lead Sponsor
University of Bern
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day for surgery and evaluations
Participants undergo implant removal surgery, including clinical and radiological evaluations, blood sample collection, and implant surface analysis.
1 surgical visit with blood collection and clinical assessments
Duration - 4 weeks
Participants attend follow-up visits to monitor healing, remove sutures, and perform clinical and radiological assessments including blood sample collection.
1 visit 1 week after surgery and 1 visit 4 weeks after surgery
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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https://pubmed.ncbi.nlm.nih.gov/30075090/Wroclaw Medical University
Lead Sponsor
University of Bern
Collaborating Sponsor