Effect of Metallic Particles on the Progression of Peri-Implantitis

Sponsor
University of Barcelona
Study ID
NCT07792499
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Study Details

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.

Key Dates

First listed
Aug 28, 2026
Start date
Oct 1, 2026
Status verified
Aug 2026
Primary completion
Sep 3, 2027
Completion
Mar 30, 2028

Study Design

Enrollment
50 participants (estimated)

Arms

  • Arm: Peri-implantitis
    Inclusion Criteria Adult patients (≥18 years old) diagnosed with peri-implantitis according to the definition established by the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions (Berglundh et al., 2018). Implants presenting bleeding on probing and/or suppuration, increased probing depth, and progressive bone loss compared with previous records. When previous records are unavailable, implants will be included if they present bleeding and/or suppuration on gentle probing, probing depth ≥ 6 mm, and a bone level ≥ 3 mm apical to the most coronal portion of the implant's rough surface.
  • Arm: Control: prior to implant placement
    To be considered eligible for participation in this study, patients must fulfil all the following criteria: 1. Written informed consent duly completed and signed for participation in the study and the use of biological samples. 2. Male or female adult patients. 3. 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. 4. Patients in full possession of their mental faculties and capable of understanding and providing written informed consent. 5. Willingness to comply with all study procedures. In addition, participants must meet the criteria for being part of the control group: 1. Candidate for implant therapy, with the placement of at least one dental implant included in the treatment plan. 2. Candidate for implant placement using a static computer-guided surgical approach. 3. Availability of soft tissue from the implant recipient site for sample collection (≥ 3 mm).

Primary Outcome Measure

Concentration of metallic elements (Ti, Al, V, Mo and Cr) in tissue samples (ppb). [ Time Frame: Day 1 ]

Central Contacts

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