Immunological-Clinical Evaluation of the Etiopathogenesis of Peri-Implantitis
NCT ID: NCT07012915
Last Updated: 2025-07-10
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
RECRUITING
Clinical Phase
NA
Total Enrollment
100 participants
Study Classification
INTERVENTIONAL
Study Start Date
2025-07-01
Study Completion Date
2026-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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 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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Surgical Treatment of Peri-implantitis With and Without an Initial Non-surgical Approach
NCT03620331
Peri-Implantitis
COMPLETED
NA
Molecular Biology in the Identification of Pathogens at Reimplantation in the Two-Stage Treatment of Periprosthetic Infections
NCT06804265
Periprosthetic Joint Infection (PJI)
RECRUITING
Longitudinal Evaluation of Regenerative Treatment of Peri-implantitis Assited by Er,Cr:YSGG Laser: up to 10 Years Follow-up
NCT07104760
Peri-Implantitis and Peri-implant Mucositis
Peri-Implantitis and Systemic Inflammation
ACTIVE_NOT_RECRUITING
Patients' Illness Perception of Peri-implant Diseases. A Cross-sectional Study
NCT06383351
Peri-implant Mucositis
Perception
Survey
+2 more
COMPLETED
Incidence of Peri-implant Mucositis in Patients With Treated Periodontitis
NCT05356806
Peri-implant Mucositis
RECRUITING
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The following research experiment project is part of the scientific section of a project funded under the Erasmus+ program (KA220-HED - Cooperation partnerships in higher education) entitled "Integrating Peri-Implantitis Research into Higher Education Curriculum - Developing and Integrating Evidence-Based Teaching Materials and Clinical Tools." According to the current state of knowledge, there are two main theories explaining the development of peri-implantitis. The first theory suggests that the primary etiological factor is the invasion of periopathogens along the gingival crevice surrounding the implant, resembling the pathogenic development seen in natural periodontal diseases such as gingivitis and periodontitis. In this scenario, bacterial invasion is facilitated by the distinct structure of the peri-implant soft tissues, which differ from natural gingival tissue in several ways: a more uniaxial, parallel orientation of collagen fibers relative to the implant's long axis, lower cellular density, and reduced mitotic potential of the surrounding soft tissue.
The second theory proposes that marginal bone loss around the implant is the result of an immuno-osteolytic reaction, with pathogenic bacteria appearing as a secondary phenomenon. According to this theory, the initiation of the pathological process is attributed to an immune response triggered by the presence of titanium ions and other metallic elements, such as vanadium, which is commonly found in titanium alloys. In vitro models have demonstrated that an increase in Ti concentration leads to macrophage activation and increased secretion of pro-inflammatory cytokines, particularly interleukin IL-1B and arachidonic acid derivatives. This macrophage activation is significantly higher in cases where prior bacterial lipopolysaccharide (LPS) exposure has occurred, suggesting an additive effect of bacterial factors in the overall disease process. Furthermore, vanadium appears to disrupt the balance of T/B lymphocytes, suppress the secretion of anti-inflammatory cytokines, and activate the innate immune response via Toll-like receptors and NF-κB signaling pathways.
Despite conceptual differences between these two theories, both agree on the fundamental premise that biological processes occurring on the implant surface and in its immediate vicinity play a critical role in the development of peri-implantitis. These processes are modulated by the physicochemical properties of the implant surface.
The immuno-osteolytic concept of peri-implantitis, also known as the foreign body reaction theory, is largely based on physicochemical changes that occur on the implant surface over time due to its exposure to the oral tissue environment. These changes are associated with gradual degradation, corrosion, and aging of titanium alloys.
In biomedical applications, biphasic titanium alloys are most commonly used, particularly the Ti-6Al-4V alloy, which contains 6% aluminum and 4% vanadium. Aluminum stabilizes the α-phase, improving mechanical strength and reducing weight, while vanadium stabilizes the β-phase, enhancing alloy plasticity.
All known metals and alloys undergo corrosion under specific conditions. Most of them are thermodynamically unstable, tending to transition from their metallic state to ionic form. The degree of thermodynamic stability of a metal is characterized by its standard electrode potential, which describes the free energy change when an ion transitions from the metal to a solution. The more negative the standard electrode potential, the lower the metal's resistance to corrosion. The standard ionization potential of titanium is theoretically established at 1.63V, indicating high electrochemical potential and corrosion susceptibility of pure titanium. However, in practice, titanium exhibits lower corrosion potential due to its tendency to undergo passivation, forming a stable oxide layer that acts as a barrier preventing direct contact between the metal and the external environment.
The stability of the titanium dioxide (TiO₂) passive layer in the oral cavity is compromised by salivary enzymes and bacterial metabolism, particularly acidic byproducts such as lactic, acetic, and propionic acids. These substances create localized pH shifts towards acidity, which are unfavorable for titanium alloys and accelerate corrosion. Another factor increasing titanium corrosion in dental applications is the presence of fluoride compounds, which are commonly used in toothpaste, mouthwashes, gels, and fluoride foams. In aqueous solutions, fluoride exists primarily as the fluoride ion (F-), which has the ability to dissolve the passive oxide layer on titanium, significantly increasing corrosion rates.
A separate concern is the fatigue-related degradation of titanium implants. These fatigue processes are associated with repeated mechanical stress, particularly non-linear loading patterns. The first observable sign of fatigue is the formation of microcracks, detectable via scanning electron microscopy (SEM). In advanced stages, these microcracks lead to wear-corrosion phenomena, further accelerating surface degradation of titanium alloys.
Objectives of the Medical Experiment:
Clinical assessment of oral health, with a particular focus on periodontal indicators and oral hygiene status in participants affected by peri-implantitis.
Radiological evaluation of bone structure affected by peri-implantitis. Hematological assessment of peri-implantitis markers and the immunological profile of participants diagnosed with peri-implantitis.
Measurement of Ti++ ion concentrations and other metallic elements present in titanium alloys in tissues surrounding implants affected by peri-implantitis.
Corrosion analysis and SEM-based fatigue analysis of implant surfaces associated with peri-implantitis.
Study design 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 (Sapienza University of Rome, University of Barcelona, University of Bern, and Egas Moniz University) will submit an application to their respective local bioethics committee for approval to conduct the medical experiment.
Eligibility Criteria To be eligible for the study, participants must have undergone previous implant treatment that has resulted in active, advanced peri-implantitis.
During the initial visit, patients will undergo a medical interview to document their systemic diseases and dental treatment history, with particular emphasis on:
The type and brand of implant The prosthetic loading type of the implant The location and time of implantation The onset and treatment history of peri-implantitis
Each participant will then undergo a dental examination, utilizing a UNC15 periodontal probe (DepplerSA, Roller, Switzerland). This assessment will include:
Oral hygiene indicators: Oral Hygiene Index (OHI), Aproximal Plaque Index (API) Periodontal disease indices: Community Index of Periodontal Treatment Needs (CPITN) Occlusal abnormalities and increased facial muscle tension, particularly in the mentalis muscle and oral floor muscles Implant-Specific Assessments
For the implant site, the following parameters will be evaluated:
Pocket Depth (PD) - measured on four surfaces around the implant Bleeding on Probing (BoP) Index Width and height of the attached gingiva (HKT, WKT) Possible implant mobility, assessed using the Mobility Index (MOB) Following the clinical examination, each participant will be referred for a Cone Beam Computed Tomography (CBCT) scan.
CBCT Examination
The CBCT scan will be routinely evaluated, focusing on the implant region, with measurements including:
Bone loss percentage, 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).
Bone density, measured in Hounsfield units (HU)
A peri-implantitis process will be classified as active if:
PD at the implant site exceeds 6mm, with a positive BoP index Advanced peri-implantitis is diagnosed if bone loss exceeds 66% on at least one implant surface Treatment Eligibility Criteria According to established literature, in cases of active, advanced peri-implantitis, where bone loss exceeds 50% of the implant length, implant removal is considered the appropriate therapeutic approach. Only patients meeting this criterion will be enrolled in the project.
Exclusion Criteria:
General and local contraindications for surgical procedures Pregnancy Use of bisphosphonates or other antiresorptive medications in medical history Patients who do not meet the implant removal criteria and are not eligible for the study will be directed toward non-surgical or conservative-surgical treatment options.
Laboratory Analysis Procedures
During a subsequent procedural visit, a 20ml venous blood sample will be collected from the antecubital vein of each participant. The blood samples will be preserved in EDTA tubes and sent to a laboratory for further analysis, including:
Hematological Inflammation Indices: Systemic Immune-Inflammation Index (SII), Aggregate Index of Systemic Inflammation (AISI), Complete blood count with quantitative and percentage analysis, Indicator of Peri-Implantitis and Periodontal Disease Development: morphology by quantitative and percentage separation, Lipid profile: (CHOL , HDL, LDL, TG, APOA1, APOB);
* Inflammatory markers: CRP, ESR, ALB, TP, TF, FIB;
* Cytokine profile: TNF, IL- 1β, IL-6, IL-8, IL-10;
* HOMA2 Parameters: Glucose, Insulin, C-Peptide, HBA1;
* Thyroid profile:- TSH, FT3, FT4, T3, T4, rT3;
* Vitamin D level - 25(OH)D, 1.25(OH)2 D3 Laboratory and Surgical Procedures Each partner institution will conduct laboratory tests and clinical procedures at their respective clinical locations, in collaboration with a certified analytical laboratory.
Next, each participant will undergo implant explantation surgery, during which tissue samples will be collected for further analysis, followed by immediate bone defect regeneration at the implantation site. The procedure will be preceded by removal of the prosthetic restoration.
Following oral disinfection with a 0.2% alcohol-based chlorhexidine solution, local infiltration anesthesia will be administered using 2% articaine with epinephrine 1:200,000. A flap incision will be performed to access the peri-implant region.
A trephine drill with the smallest possible diameter will then be selected to encompass the implant collar. Using the following drilling parameters-800 rpm, 20 Ncm torque, and 0.9% NaCl irrigation-the drill will be lowered to the apical depth of the implant. The implant will be extracted along with any bone tissue tightly adhered to its surface.
The implant and bone tissue will be preserved in a 5% formalin solution. The surgical site will be sutured using non-resorbable 5-0 monofilament sutures.
Both specimens will be sent to research centers in Poland. The implant and tissue samples will be transferred to the Department of Inorganic Chemistry, Analytical Chemistry, and Electrochemistry at the Silesian University of Technology in Gliwice, Poland.
Laboratory Analysis
In the laboratory, biological material will be separated from the samples. The following analyses will be performed:
Titanium concentration measurement and detection of other metals present in the titanium alloy.
Implant surface will be analysed using: Light microscopy, Scanning electron microscopy (SEM), corrosion testing. The microscopic examination will assess the implant surface, identifying areas with fatigue-related material degradation, such as microcracks.
Post-Explantation Follow-Up
One week after the explantation procedure, a follow-up visit will take place. During this visit:
Surgical sutures will be removed. The healing process of the surgical wound will be assessed. If no complications are detected, the next follow-up visit will be scheduled four weeks later. During the four-week follow-up visit, the following evaluations will be performed:
Clinical assessment of the implantation site, including HKT and WKT parameters A second CBCT scan: to assess bone structure in the post-implantation region, with measurements including: Percentage of bone loss, calculated as the ratio of the smallest vertical dimension of the alveolar ridge in the post-implantation area to the height of the alveolar ridge in the immediate vicinity
Blood Sample Collection:
20ml of venous blood will be collected from the antecubital vein of each participant.
The blood sample will be preserved in EDTA tubes and sent to an analytical laboratory for further testing, including same parameters as mentioned previously.
The second theory proposes that marginal bone loss around the implant is the result of an immuno-osteolytic reaction, with pathogenic bacteria appearing as a secondary phenomenon. According to this theory, the initiation of the pathological process is attributed to an immune response triggered by the presence of titanium ions and other metallic elements, such as vanadium, which is commonly found in titanium alloys. In vitro models have demonstrated that an increase in Ti concentration leads to macrophage activation and increased secretion of pro-inflammatory cytokines, particularly interleukin IL-1B and arachidonic acid derivatives. This macrophage activation is significantly higher in cases where prior bacterial lipopolysaccharide (LPS) exposure has occurred, suggesting an additive effect of bacterial factors in the overall disease process. Furthermore, vanadium appears to disrupt the balance of T/B lymphocytes, suppress the secretion of anti-inflammatory cytokines, and activate the innate immune response via Toll-like receptors and NF-κB signaling pathways.
Despite conceptual differences between these two theories, both agree on the fundamental premise that biological processes occurring on the implant surface and in its immediate vicinity play a critical role in the development of peri-implantitis. These processes are modulated by the physicochemical properties of the implant surface.
The immuno-osteolytic concept of peri-implantitis, also known as the foreign body reaction theory, is largely based on physicochemical changes that occur on the implant surface over time due to its exposure to the oral tissue environment. These changes are associated with gradual degradation, corrosion, and aging of titanium alloys.
In biomedical applications, biphasic titanium alloys are most commonly used, particularly the Ti-6Al-4V alloy, which contains 6% aluminum and 4% vanadium. Aluminum stabilizes the α-phase, improving mechanical strength and reducing weight, while vanadium stabilizes the β-phase, enhancing alloy plasticity.
All known metals and alloys undergo corrosion under specific conditions. Most of them are thermodynamically unstable, tending to transition from their metallic state to ionic form. The degree of thermodynamic stability of a metal is characterized by its standard electrode potential, which describes the free energy change when an ion transitions from the metal to a solution. The more negative the standard electrode potential, the lower the metal's resistance to corrosion. The standard ionization potential of titanium is theoretically established at 1.63V, indicating high electrochemical potential and corrosion susceptibility of pure titanium. However, in practice, titanium exhibits lower corrosion potential due to its tendency to undergo passivation, forming a stable oxide layer that acts as a barrier preventing direct contact between the metal and the external environment.
The stability of the titanium dioxide (TiO₂) passive layer in the oral cavity is compromised by salivary enzymes and bacterial metabolism, particularly acidic byproducts such as lactic, acetic, and propionic acids. These substances create localized pH shifts towards acidity, which are unfavorable for titanium alloys and accelerate corrosion. Another factor increasing titanium corrosion in dental applications is the presence of fluoride compounds, which are commonly used in toothpaste, mouthwashes, gels, and fluoride foams. In aqueous solutions, fluoride exists primarily as the fluoride ion (F-), which has the ability to dissolve the passive oxide layer on titanium, significantly increasing corrosion rates.
A separate concern is the fatigue-related degradation of titanium implants. These fatigue processes are associated with repeated mechanical stress, particularly non-linear loading patterns. The first observable sign of fatigue is the formation of microcracks, detectable via scanning electron microscopy (SEM). In advanced stages, these microcracks lead to wear-corrosion phenomena, further accelerating surface degradation of titanium alloys.
Objectives of the Medical Experiment:
Clinical assessment of oral health, with a particular focus on periodontal indicators and oral hygiene status in participants affected by peri-implantitis.
Radiological evaluation of bone structure affected by peri-implantitis. Hematological assessment of peri-implantitis markers and the immunological profile of participants diagnosed with peri-implantitis.
Measurement of Ti++ ion concentrations and other metallic elements present in titanium alloys in tissues surrounding implants affected by peri-implantitis.
Corrosion analysis and SEM-based fatigue analysis of implant surfaces associated with peri-implantitis.
Study design 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 (Sapienza University of Rome, University of Barcelona, University of Bern, and Egas Moniz University) will submit an application to their respective local bioethics committee for approval to conduct the medical experiment.
Eligibility Criteria To be eligible for the study, participants must have undergone previous implant treatment that has resulted in active, advanced peri-implantitis.
During the initial visit, patients will undergo a medical interview to document their systemic diseases and dental treatment history, with particular emphasis on:
The type and brand of implant The prosthetic loading type of the implant The location and time of implantation The onset and treatment history of peri-implantitis
Each participant will then undergo a dental examination, utilizing a UNC15 periodontal probe (DepplerSA, Roller, Switzerland). This assessment will include:
Oral hygiene indicators: Oral Hygiene Index (OHI), Aproximal Plaque Index (API) Periodontal disease indices: Community Index of Periodontal Treatment Needs (CPITN) Occlusal abnormalities and increased facial muscle tension, particularly in the mentalis muscle and oral floor muscles Implant-Specific Assessments
For the implant site, the following parameters will be evaluated:
Pocket Depth (PD) - measured on four surfaces around the implant Bleeding on Probing (BoP) Index Width and height of the attached gingiva (HKT, WKT) Possible implant mobility, assessed using the Mobility Index (MOB) Following the clinical examination, each participant will be referred for a Cone Beam Computed Tomography (CBCT) scan.
CBCT Examination
The CBCT scan will be routinely evaluated, focusing on the implant region, with measurements including:
Bone loss percentage, 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).
Bone density, measured in Hounsfield units (HU)
A peri-implantitis process will be classified as active if:
PD at the implant site exceeds 6mm, with a positive BoP index Advanced peri-implantitis is diagnosed if bone loss exceeds 66% on at least one implant surface Treatment Eligibility Criteria According to established literature, in cases of active, advanced peri-implantitis, where bone loss exceeds 50% of the implant length, implant removal is considered the appropriate therapeutic approach. Only patients meeting this criterion will be enrolled in the project.
Exclusion Criteria:
General and local contraindications for surgical procedures Pregnancy Use of bisphosphonates or other antiresorptive medications in medical history Patients who do not meet the implant removal criteria and are not eligible for the study will be directed toward non-surgical or conservative-surgical treatment options.
Laboratory Analysis Procedures
During a subsequent procedural visit, a 20ml venous blood sample will be collected from the antecubital vein of each participant. The blood samples will be preserved in EDTA tubes and sent to a laboratory for further analysis, including:
Hematological Inflammation Indices: Systemic Immune-Inflammation Index (SII), Aggregate Index of Systemic Inflammation (AISI), Complete blood count with quantitative and percentage analysis, Indicator of Peri-Implantitis and Periodontal Disease Development: morphology by quantitative and percentage separation, Lipid profile: (CHOL , HDL, LDL, TG, APOA1, APOB);
* Inflammatory markers: CRP, ESR, ALB, TP, TF, FIB;
* Cytokine profile: TNF, IL- 1β, IL-6, IL-8, IL-10;
* HOMA2 Parameters: Glucose, Insulin, C-Peptide, HBA1;
* Thyroid profile:- TSH, FT3, FT4, T3, T4, rT3;
* Vitamin D level - 25(OH)D, 1.25(OH)2 D3 Laboratory and Surgical Procedures Each partner institution will conduct laboratory tests and clinical procedures at their respective clinical locations, in collaboration with a certified analytical laboratory.
Next, each participant will undergo implant explantation surgery, during which tissue samples will be collected for further analysis, followed by immediate bone defect regeneration at the implantation site. The procedure will be preceded by removal of the prosthetic restoration.
Following oral disinfection with a 0.2% alcohol-based chlorhexidine solution, local infiltration anesthesia will be administered using 2% articaine with epinephrine 1:200,000. A flap incision will be performed to access the peri-implant region.
A trephine drill with the smallest possible diameter will then be selected to encompass the implant collar. Using the following drilling parameters-800 rpm, 20 Ncm torque, and 0.9% NaCl irrigation-the drill will be lowered to the apical depth of the implant. The implant will be extracted along with any bone tissue tightly adhered to its surface.
The implant and bone tissue will be preserved in a 5% formalin solution. The surgical site will be sutured using non-resorbable 5-0 monofilament sutures.
Both specimens will be sent to research centers in Poland. The implant and tissue samples will be transferred to the Department of Inorganic Chemistry, Analytical Chemistry, and Electrochemistry at the Silesian University of Technology in Gliwice, Poland.
Laboratory Analysis
In the laboratory, biological material will be separated from the samples. The following analyses will be performed:
Titanium concentration measurement and detection of other metals present in the titanium alloy.
Implant surface will be analysed using: Light microscopy, Scanning electron microscopy (SEM), corrosion testing. The microscopic examination will assess the implant surface, identifying areas with fatigue-related material degradation, such as microcracks.
Post-Explantation Follow-Up
One week after the explantation procedure, a follow-up visit will take place. During this visit:
Surgical sutures will be removed. The healing process of the surgical wound will be assessed. If no complications are detected, the next follow-up visit will be scheduled four weeks later. During the four-week follow-up visit, the following evaluations will be performed:
Clinical assessment of the implantation site, including HKT and WKT parameters A second CBCT scan: to assess bone structure in the post-implantation region, with measurements including: Percentage of bone loss, calculated as the ratio of the smallest vertical dimension of the alveolar ridge in the post-implantation area to the height of the alveolar ridge in the immediate vicinity
Blood Sample Collection:
20ml of venous blood will be collected from the antecubital vein of each participant.
The blood sample will be preserved in EDTA tubes and sent to an analytical laboratory for further testing, including same parameters as mentioned previously.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Peri-Implantitis
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
NA
Intervention Model
SINGLE_GROUP
Healthy adult participants, suffering from Peri-Implantitis. Every participant from a total number of 100 will have blood sample collected twice before and 4 weeks following implant removal for detailed evaluation. Furthermore, the Cone Beam Computed Tomography will be applied to evaluate the severity and shape of bone defect. Removed implants will be send for detailed chemical evaluation.
Primary Study Purpose
PREVENTION
Blinding Strategy
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Study group
Every participant will achieve same intervention when it comes to surgical treatment, clinical examination, radiology evaluation and defined parameters of blood serum.
Group Type
EXPERIMENTAL
Blood testing
Intervention Type
DIAGNOSTIC_TEST
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Intervention Type
DIAGNOSTIC_TEST
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Radiation
Surgery
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are 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
* 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
* Pregnancy
* Use of bisphosphonates or other antiresorptive medications in medical history
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Bern
OTHER
Sponsor Role
collaborator
University of Barcelona
OTHER
Sponsor Role
collaborator
University of Roma La Sapienza
OTHER
Sponsor Role
collaborator
Egas Moniz - Cooperativa de Ensino Superior, CRL
OTHER
Sponsor Role
collaborator
Wroclaw Medical University
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Responsibility Role
SPONSOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Marzena Dominiak, Prof
Role: STUDY_CHAIR
Wroclaw Medical Univeristy
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Oral Surgery Department Wroclaw Medical University
Wroclaw, Lower Silesian Voivodeship, Poland
Site Status
RECRUITING
Countries
Review the countries where the study has at least one active or historical site.
Poland
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Elani HW, Starr JR, Da Silva JD, Gallucci GO. Trends in Dental Implant Use in the U.S., 1999-2016, and Projections to 2026. J Dent Res. 2018 Dec;97(13):1424-1430. doi: 10.1177/0022034518792567. Epub 2018 Aug 3.
Reference Type
BACKGROUND
Fu JH, Wang HL. Breaking the wave of peri-implantitis. Periodontol 2000. 2020 Oct;84(1):145-160. doi: 10.1111/prd.12335.
Reference Type
BACKGROUND
Schwarz F, Claus C, Becker K. Correlation between horizontal mucosal thickness and probing depths at healthy and diseased implant sites. Clin Oral Implants Res. 2017 Sep;28(9):1158-1163. doi: 10.1111/clr.12932. Epub 2016 Jul 26.
Reference Type
BACKGROUND
Schwarz F, Derks J, Monje A, Wang HL. Peri-implantitis. J Periodontol. 2018 Jun;89 Suppl 1:S267-S290. doi: 10.1002/JPER.16-0350.
Reference Type
BACKGROUND
Albrektsson T, Canullo L, Cochran D, De Bruyn H. "Peri-Implantitis": A Complication of a Foreign Body or a Man-Made "Disease". Facts and Fiction. Clin Implant Dent Relat Res. 2016 Aug;18(4):840-9. doi: 10.1111/cid.12427. Epub 2016 May 30.
Reference Type
BACKGROUND
Pettersson M, Kelk P, Belibasakis GN, Bylund D, Molin Thoren M, Johansson A. Titanium ions form particles that activate and execute interleukin-1beta release from lipopolysaccharide-primed macrophages. J Periodontal Res. 2017 Feb;52(1):21-32. doi: 10.1111/jre.12364. Epub 2016 Mar 14.
Reference Type
BACKGROUND
Tsave O, Petanidis S, Kioseoglou E, Yavropoulou MP, Yovos JG, Anestakis D, Tsepa A, Salifoglou A. Role of Vanadium in Cellular and Molecular Immunology: Association with Immune-Related Inflammation and Pharmacotoxicology Mechanisms. Oxid Med Cell Longev. 2016;2016:4013639. doi: 10.1155/2016/4013639. Epub 2016 Apr 11.
Reference Type
BACKGROUND
Scibior A, Pietrzyk L, Plewa Z, Skiba A. Vanadium: 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. J Trace Elem Med Biol. 2020 Sep;61:126508. doi: 10.1016/j.jtemb.2020.126508. Epub 2020 Apr 12.
Reference Type
BACKGROUND
Grande F, Tucci P. Titanium Dioxide Nanoparticles: a Risk for Human Health? Mini Rev Med Chem. 2016;16(9):762-9. doi: 10.2174/1389557516666160321114341.
Reference Type
BACKGROUND
Zhang HM, Cao J, Tang BP, Wang YQ. Effect of TiO(2) nanoparticles on the structure and activity of catalase. Chem Biol Interact. 2014 Aug 5;219:168-74. doi: 10.1016/j.cbi.2014.06.005. Epub 2014 Jun 12.
Reference Type
BACKGROUND
Chen WQ, Zhang SM, Qiu J. Surface analysis and corrosion behavior of pure titanium under fluoride exposure. J Prosthet Dent. 2020 Aug;124(2):239.e1-239.e8. doi: 10.1016/j.prosdent.2020.02.022. Epub 2020 May 10.
Reference Type
BACKGROUND
Trepanier C, Tabrizian M, Yahia LH, Bilodeau L, Piron DL. Effect of modification of oxide layer on NiTi stent corrosion resistance. J Biomed Mater Res. 1998 Winter;43(4):433-40. doi: 10.1002/(sici)1097-4636(199824)43:43.0.co;2-#.
Reference Type
BACKGROUND
Chouirfa H, Bouloussa H, Migonney V, Falentin-Daudre C. Review of titanium surface modification techniques and coatings for antibacterial applications. Acta Biomater. 2019 Jan 1;83:37-54. doi: 10.1016/j.actbio.2018.10.036. Epub 2018 Oct 26.
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
KA220-HED
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Monitoring of Implant Diseases: Diagnosis and Monitoring with AMMP-8 Test Technology
NCT06761521
ENROLLING_BY_INVITATION
NA
Patient Perception and Clinical Efficacy of a Collagen Matrix for the Treatment of Peri-implantitis
NCT03551145
UNKNOWN
PHASE4
Study of Systemic Impact of Trace Elements Release by Implantable Medical Devices. Identification of Biomarkers of Systemic Inflammation
NCT03812627
COMPLETED
NA
Microbiota Around Periodontal Teeth and Implants Affected by Peri-implant Disease.
NCT03407911
COMPLETED
Surgical Treatment of Periimplantitis in Patients With Risk Factors
NCT03814434
UNKNOWN
NA
Compliance and Cumulative Interceptive Rate After Therapy of Peri-implantitis
NCT05772078
COMPLETED
Resective Surgical Treatment of Peri-implantitis.
NCT04337645
UNKNOWN
NA
Health of Peri-implant Tissues Adjacent to Zirconia
NCT05081076
COMPLETED
NA
Early and Late Implant Failure
NCT04270396
COMPLETED
Lnfluence of the Prosthetic Emergence Profile on the Prevalence of Peri-implant Diseases
NCT05592314
RECRUITING
Implant Survival and Peri-abutment Tissue Reactions of Extra-oral Implants.
NCT03182361
COMPLETED
NA
Non-surgical Treatment of Periimplantitis - Conventional Hand Instrumentation Versus Air-polishing
NCT05811390
COMPLETED
NA
Cross-sectional Examination of the Reliability of Oral Implants
NCT04690621
COMPLETED
Distance Between Dental Implants as a Risk Indicator for Peri-implant Disease.
NCT06364982
RECRUITING
Evaluation of the Success Rate of Immediately Loaded Implants
NCT00314015
COMPLETED
NA
Lasers in Peri-implantitis Treatment
NCT05733234
COMPLETED
NA
Epstein-Barr Virus Implication in Peri-implantitis: Towards an Innovative Etiopathogenic Model.
NCT03631849
COMPLETED
NA
Peri-implant Disease and Prosthetic Cement: Cross-sectional Study
NCT05945836
COMPLETED
Histological, Genetic and Epigenetic Analysis of Procedures Related with Dental Implants
NCT04421066
COMPLETED
Combined Er:YAG And Nd:YAG Laser Protocol For Treatment Of Peri-Implantitis
NCT03819075
UNKNOWN
NA
The Study on the Accuracy of Peri-implant Probing and Related Influencing Factors
NCT07004517
RECRUITING
"Surgical Vs. Non-surgical Peri-implant Therapy"
NCT05168891
COMPLETED
NA
Alveolar Ridge Sequelae Due to Peri-implantitis: a Retrospective Observational Study
NCT04534361
COMPLETED
Treatment of Peri-implant Mucositis by Means of Implant Decontamination and Modification of the Implant Supported-prosthesis
NCT03540290
UNKNOWN
NA
Long-term Surgical Treatment Outcome of Peri-implantitis Lesions
NCT05339789
RECRUITING