Actively Recruiting
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
78 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
A total of 100 adult volunteers of both sexes will be enrolled in the project. The study will be conducted within an international consortium formed for the project, comprising the following institutions: Wroclaw Medical University (Poland), Sapienza University of Rome (Italy), University of Barcelona (Spain), University of Bern (Switzerland), and Egas Moniz University (Portugal). Each international partner institution will recruit 20 volunteers as participants in the experiment. Each of the participating institutions will submit an application to their respective local bioethics committee for approval to conduct the medical experiment. Each partner institution will conduct procedures at their respective clinical locations. Eligibility Criteria participants must have undergone previous implant treatment that has resulted in active, advanced peri-implantitis. Exclusion Criteria: General and local contraindications for surgical procedures Pregnancy; Use of bisphosphonates or other antiresorptive medications in medical history Laboratory Analysis Procedures. During the initial visit, patients will undergo a medical interview and a dental examination with regard to: Oral Hygiene Indices; Periodontal disease indices. For the implant site, the following parameters will be evaluated: Pocket Depth Bleeding on Probing Width and height of the attached gingiva Possible implant mobility, assessed using the Mobility Index Following the clinical examination, each participant will be referred for a Cone Beam Computed Tomography (CBCT) scan with measurements including: Bone loss percentage for each of the four implant surfaces, Bone density. Next, a 20ml venous blood sample will be collected from the antecubital vein of each participant and sent to a laboratory for further analysis, including: Hematological Inflammation Indices: Systemic Immune-Inflammation Index, Aggregate Index of Systemic Inflammation, Complete blood count, Lipid profile, APOA., APOBg, Inflammatory markers, albumin, total protein, total ferritin, fibrinogen, Cytokine profile, HOMA2 Parameters, Thyroid profile, Vitamin D level Next, each participant will undergo implant explantation surgery, during which tissue samples will be collected for further analysis. Implant surface will be analyzed using: light microscopy, scanning electron microscopy, corrosion testing. Follow-Up will be scheduled four weeks later with following evaluation: Clinical assessment of the implantation site. A CBCT scan to assess bone structure in the post-implantation region, with measurements including percentage of bone loss. Moreover, 20ml of venous blood will be collected from the antecubital vein of each participant. The blood sample will be preserved and sent to an analytical laboratory for further testing, including for same as previously mentioned tests.
CONDITIONS
Official Title
Immunological-Clinical Evaluation of the Etiopathogenesis of Peri-Implantitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pocket depth at the implant site exceeds 6mm
- Positive bleeding on probing index
- Bone loss over 66% on at least one implant surface
You will not qualify if you...
- General and local contraindications for surgical procedures
- Pregnancy
- History of bisphosphonate or other antiresorptive medication use
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Oral Surgery Department Wroclaw Medical University
Wroclaw, Lower Silesian Voivodeship, Poland, 50425
Actively Recruiting
Research Team
P
Pawel Kubasiewicz-Ross, PhD, DDS
CONTACT
J
Jacek Matys, PhD, DDS
CONTACT
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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