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Clinical Trials in Poland / NCT07012915
Recruiting Not applicable

Immunological-Clinical Evaluation of the Etiopathogenesis of Peri-Implantitis

NCT07012915 · tracked via the Priya Life Science Poland tracker
Sponsor
Wroclaw Medical University
Phase
Not applicable
Started
2025-07-01
Last updated
2025-07-10

Condition(s) studied

Peri-Implantitis

Investigational drug(s) / intervention(s)

Blood testing

Blood testing: Blood sample will be collected twice for each participants procedding and following dental implant removal. Cone Beam Computed Tomography will be applied to evaluate the shape, severity of bone defect in direct viscinity of the implant.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • Blood testing, total blood count, and indices derived from it. — On the day of implant removal (before implant removal) and 4 weeks after.
    Hematological Inflammation Indices: Systemic Immune-Inflammation Index (SII) calculated as follows: SII=NEUxPLT/LYMPH
  • Blood testing, total blood count, and indices derived from it. — On the day of implant removal (before implant removal) and 4 weeks after.
    Hematological Inflammation Indices: Aggregate Index of Systemic Inflammation (AISI) calculated as follows: AISI= NEU×PLTxMON/LYMP
  • Blood testing, lipid profile. — On the day of implant removal (before implant removal) and 4 weeks after.
    CHOL mg/dl , HDL mg/dl, LDL mg/dl, TG mg/dl, APOA1 mg/dl, APOB mg/dl
  • Blood testing, Inflammatory markers. — On the day of implant removal (before implant removal) and 4 weeks after.
    Inflammatory markers: CRP mg/l, albumin (ALB) mg/dl, TP mg/dl,TF mg/dl, FIB mg/dl
  • Blood testing, Inflammatory marker. — On the day of implant removal (before implant removal) and 4 weeks after.
    ESR mm/h
  • Blood testing, Cytokine profile. — On the day of implant removal (before implant removal) and 4 weeks after.
    TNF- α pg/ml , IL- 1β pg/ml, IL-6 pg/ml, IL-8 pg/ml, IL-10 pg/ml
  • Blood testing, HOMA2 Parameters — On the day of implant removal (before implant removal) and 4 weeks after.
    HOMA2 Parameters - Glucose mg/dl, C-Peptide mg/dl,
  • Blood testing, HOMA2 Parameters — On the day of implant removal (before implant removal) and 4 weeks after.
    Insulin mU/ml
  • Blood testing, HOMA2 Parameters — On the day of implant removal (before implant removal) and 4 weeks after.
    HBA1C %
  • Blood testing, Thyroid profile — On the day of implant removal (before implant removal) and 4 weeks after.
    TSH μIU/ml
  • Blood testing, Thyroid profile — On the day of implant removal (before implant removal) and 4 weeks after.
    FT3 ng/l, FT4 ng/l
  • Blood testing, Thyroid profile — On the day of implant removal (before implant removal) and 4 weeks after.
    T3 ng/dl, T4 ng/dl
  • Blood testing, Thyroid profile — On the day of implant removal (before implant removal) and 4 weeks after.
    rT3 ng/ml
  • Blood testing, Vitamin D3 level — On the day of implant removal (before implant removal) and 4 weeks after.
    25(OH)D, 1.25(OH)2 D3 ng/ml
  • Clinical examination - general, oral cavity — On the day of implant removal (before implant removal) and 4 weeks after.
    Oral Hygiene Index (OHI) %, Aproximal Plaque Index (API) %
  • Clinical examination - general, oral cavity, utilizing a UNC15 periodontal probe — On the day of implant removal (before implant removal).
    Community Index of Periodontal Treatment Needs (CPITN)
  • Clinical examination - implant site, utilizing a UNC15 periodontal probe — On the day of implant removal (before implant removal).
    Pocket Depth (PD) - measured on four surfaces around the implant in mm.
  • Clinical examination - implant site, utilizing a UNC15 periodontal probe — On the day of implant removal (before implant removal).
    Bleeding on Probing (BoP) Index - Yes or No. (0 or 1).
  • Clinical examination - implant site, utilizing a UNC15 periodontal probe — On the day of implant removal (before implant removal).
    Width and height of the attached gingiva (HKT, WKT) in mm.
  • Clinical examination - implant site, utilizing a UNC15 periodontal probe — On the day of implant removal (before implant removal).
    Possible implant mobility, assessed using the Mobility Index (MOB) acc to Misch, Grade: 0,1,2 or 3
  • Radiology-based evaluation — On the day of implant removal (before implant removal).
    Cone-Beam Computed Tomography: Bone loss percentage on the implant site (%), calculated as the ratio of bone defect depth from the implant platform to the base of the defect, relative to the total implant length, assessed separately for each of the four implant surfaces (mesial, distal, buccal, and lingual/palatal)
  • Radiology-based evaluation — On the day of implant removal (before implant removal) and 4 weeks after.
    Cone-Beam Computed Tomography: Bone density on the implant site (before and after implant removal), measured in Hounsfield units (HU)
  • Implant surface evaluation, light microscopy — Within 48 hours after implant removal
    Assessment of the implant surface, identifying areas with fatigue-related material degradation, such as microcracks.
  • Implant surface evaluation, Scanning electron microscopy — Within 48 hours after implant removal
    Assessment of the implant surface, identifying areas with fatigue-related material degradation, such as microcracks.
  • Implant surface evaluation - detection of other metals presented in the titanium alloy. — Within 48 hours after implant removal
    Energy-dispersive X-ray spectroscopy (EDS)
  • Titanium ions concentration in tissues attached to implant' surface — Within 48 hours after implant removal
    Inductively coupled plasma mass spectrometry (ICP-MS)

Trial sites (1)

FacilityCityRegionStatus
Oral Surgery Department Wroclaw Medical University Wroclaw Lower Silesian Voivodeship Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07012915 on ClinicalTrials.gov ↗ ← All trials in Poland