Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT07012915

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

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

You will not qualify if you...

  • General and local contraindications for surgical procedures
  • Pregnancy
  • History of bisphosphonate or other antiresorptive medication use

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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

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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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