Trends in Dental Implant Use in the U.S., 1999-2016, and Projections to 2026.
H W Elani, J R Starr, J D Da Silva...
https://pubmed.ncbi.nlm.nih.gov/30075090Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID07012915
Immunological-Clinical Evaluation of the Etiopathogenesis of Peri-Implantitis
Led by Wroclaw Medical University · Updated on 2025-07-10
100
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
Sponsors
W
Wroclaw Medical University
Lead Sponsor
U
University of Bern
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Brief Title
Immunological-Clinical Evaluation of the Etiopathogenesis of Peri-Implantitis
Who Can Participate
Age: 18Years +
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Pocket Depth (PD) at the implant site exceeds 6mm
- Positive Bleeding on Probing (BoP) index
- Bone loss exceeding 66% on at least one implant surface
- Adults aged 18 years or older
- Previous implant treatment resulting in active, advanced peri-implantitis
You will not qualify if you...
- General and local contraindications for surgical procedures
- Pregnancy
- Use of bisphosphonates or other antiresorptive medications in medical history
AI-Screening
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Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
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
Follow-up
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
Trial Site Locations
Total: 1 location
1
Oral Surgery Department Wroclaw Medical University
Wroclaw, Lower Silesian Voivodeship, Poland, 50425
Actively Recruiting
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Research Team
P
Pawel Kubasiewicz-Ross, PhD, DDS
J
Jacek Matys, PhD, DDS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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Published Research Related To This Trial
Breaking the wave of peri-implantitis.
Jia-Hui Fu, Hom-Lay Wang
https://pubmed.ncbi.nlm.nih.gov/32844418Correlation between horizontal mucosal thickness and probing depths at healthy and diseased implant sites.
Frank Schwarz, Christian Claus, Kathrin Becker
https://pubmed.ncbi.nlm.nih.gov/27458093Peri-implantitis.
Frank Schwarz, Jan Derks, Alberto Monje...
https://pubmed.ncbi.nlm.nih.gov/29926957"Peri-Implantitis": A Complication of a Foreign Body or a Man-Made "Disease". Facts and Fiction.
Tomas Albrektsson, Luigi Canullo, David Cochran...
https://pubmed.ncbi.nlm.nih.gov/27238274Titanium 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/26987886Role of Vanadium in Cellular and Molecular Immunology: Association with Immune-Related Inflammation and Pharmacotoxicology Mechanisms.
Olga Tsave, Savvas Petanidis, Efrosini Kioseoglou...
https://pubmed.ncbi.nlm.nih.gov/27190573Vanadium: Risks and possible benefits in the light of a comprehensive overview of its pharmacotoxicological mechanisms and multi-applications with a summary of further research trends.
Agnieszka Ścibior, Łukasz Pietrzyk, Zbigniew Plewa...
https://pubmed.ncbi.nlm.nih.gov/32305626Titanium Dioxide Nanoparticles: a Risk for Human Health?
Fedora Grande, Paola Tucci
https://pubmed.ncbi.nlm.nih.gov/26996620Effect of TiO₂ nanoparticles on the structure and activity of catalase.
Hong-Mei Zhang, Jian Cao, Bo-Ping Tang...
https://pubmed.ncbi.nlm.nih.gov/24931876