About this trial
This observational cross-sectional study aims to investigate the presence and characteristics of metallic micro- and nanoparticles in peri-implant tissues and their potential association with peri-implantitis progression, the local microbiota, and the host inflammatory response.
The study will include 50 participants divided into two groups: individuals requiring dental implant placement, from whom healthy gingival tissue will be collected as an active control, and patients diagnosed with peri-implantitis, from whom granulation tissue and submucosal biofilm samples will be obtained. Tissue samples will be analysed to determine the concentration, size, morphology, and intracellular localisation of metallic particles, as well as macrophage polarisation. Microbiological analyses will characterise the peri-implant microbiota. Associations between metallic particle burden, microbiological composition, inflammatory response, and clinical and radiographic indicators of peri-implant disease severity and progression will also be explored.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Written informed consent duly completed and signed for participation in the study and the use of biological samples.
Male or female patients aged 18 years or older.
Patients treated at the Master's Degree in Oral Surgery and Implantology or the Master's Degree in Periodontology and Peri-Implantology at the University of Barcelona.
Patients in full possession of their mental faculties and capable of understanding and providing written informed consent prior to enrolment in the study.
Disqualifiers
Presence of uncontrolled periodontal disease, defined as probing depths
Immunocompromised patients.
History of radiotherapy or chemotherapy.
Presence of uncontrolled systemic diseases.
Trial population
Participants will be recruited from patients treated at the Hospital Odontològic Universitat de Barcelona (HOUB), within the Master's Degree in Oral Surgery and Implantology and the Master's Degree in Periodontology and Peri-Implantology. The Peri-implantitis Group will include patients diagnosed with peri-implantitis referred for treatment, while the Control Group will include partially or fully edentulous patients requiring first-stage surgical placement of at least one dental implant.
Trial design
Other
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Concentration of metallic elements (Ti, Al, V, Mo and Cr) in tissue samples (ppb).
The concentrations of titanium (Ti), aluminium (Al), vanadium (V), molybdenum (Mo), and chromium (Cr) will be quantified separately in healthy gingival tissue and peri-implant granulation tissue using inductively coupled plasma triple quadrupole mass spectrometry (ICP-TQ-MS). The concentration of each metallic element will be reported in parts per billion (ppb) and compared between the active control and peri-implantitis groups. Unit of Measure: Parts per billion (ppb).
Secondary outcomes
Microbial species richness and evenness within each sample (alpha diversity).
Alpha diversity of the submucosal microbiome will be assessed in biofilm samples collected from the peri-implant site with the greatest probing depth in participants with peri-implantitis. Bacterial DNA will be extracted and the microbiome characterised by 16S ribosomal RNA gene sequencing. Alpha diversity will describe microbial richness, defined as the number of microbial taxa detected within each sample, and evenness, defined as how uniformly their relative abundances are distributed. Results will be reported as alpha-diversity index values.
Microbial composition between samples from different clinical conditions (beta diversity).
Beta diversity of the submucosal microbiome will be assessed in biofilm samples collected from participants with peri-implantitis. Bacterial DNA will be extracted and the microbiome characterised by 16S ribosomal RNA gene sequencing. Beta diversity will quantify the degree of similarity or dissimilarity in the identity and relative abundance of microbial taxa between samples. These comparisons will be used to evaluate whether microbial community composition varies according to metallic particle concentration and the clinical characteristics of the sampled peri-implant sites. Results will be reported as beta-diversity distance values.
Percentage of TiO₂ Nanoparticles in Each Morphological Category
Titanium dioxide (TiO₂) nanoparticles will be evaluated in healthy gingival tissue from the active control group and peri-implant granulation tissue from the peri-implantitis group. High-resolution transmission electron microscopy (TEM) will be used to visualise the particles, and energy-dispersive X-ray spectroscopy (EDS/EDX) will confirm their elemental composition. Nanoparticles will be classified according to their observed shape and structural features. The percentage of identified TiO₂ nanoparticles in each morphological category will be reported for each sample. Unit of measure: %.
Mean Diameter of TiO₂ Nanoparticles
Titanium dioxide (TiO₂) nanoparticles will be evaluated in healthy gingival tissue from the active control group and peri-implant granulation tissue from the peri-implantitis group. High-resolution transmission electron microscopy (TEM) will be used to visualise the particles, and energy-dispersive X-ray spectroscopy (EDS/EDX) will confirm their elemental composition. Particle diameters will be measured using ImageJ image-analysis software, and the mean diameter of the identified TiO₂ nanoparticles in each sample will be reported in nanometres (Unit of Measure: nm).
Other outcomes
Presence of Plaque at the Selected Implant
Plaque will be clinically assessed at six sites around the selected implant in participants with peri-implantitis. At each peri-implant site, plaque will be recorded dichotomously as present or absent. Results will be reported as the presence or absence of plaque at each of the six assessed sites.
Probing Depth (PPD, mm)
Depth of peri-implant sulcus measured at six sites per implant using standardized probing force (20-25 g). Unit of Measure: millimeters (mm)
Bleeding and/or Suppuration on Probing (BoP/SoP)
Presence of bleeding and/or suppuration elicited within 30 seconds after gentle probing at six sites per implant using a standardized periodontal probe. Unit of Measure: Categorical (Present/Absent)
Radiographic Marginal Bone Loss (mm)
Radiographic marginal bone level measured in millimeters as the distance from the implant reference point designed to be in intimate contact with the bone to the most coronal bone-to-implant contact on standardized periapical radiographs. Unit of Measure: Millimeters (mm)
Locations
Sponsors and contacts
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University of Barcelona
Lead sponsor
Universidad de Oviedo
Collaborator
Universidad de Zaragoza
Collaborator
Universitat Autonoma de Barcelona
Collaborator
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Collaborator
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