Effect of Metallic Particles on the Progression of Peri-Implantitis

NCT07792499 | Not Yet Recruiting

• 1 other identifier: 14/2025
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Peri-implantitis

Keywords

Peri-implantitis; Dental implants; Metallic micro- and nanoparticles; Titanium particles; Peri-implant microbiota; Submucosal biofilm; Granulation tissue; Macrophage polarization

Outcome Measures

Primary Outcomes (1)

• 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).

  Day 1

Secondary Outcomes (8)

• Microbial species richness and evenness within each sample (alpha diversity).

  Day 1

• Microbial composition between samples from different clinical conditions (beta diversity).

  Day 1

• Percentage of TiO₂ Nanoparticles in Each Morphological Category

  Day 1

• Mean Diameter of TiO₂ Nanoparticles

  Day 1

• Intracellular distribution of TiO₂ nanoparticles.

  Day 1

Other Outcomes (15)

• Presence of Plaque at the Selected Implant

  Day 1

• Probing Depth (PPD, mm)

  Day 1

• Bleeding and/or Suppuration on Probing (BoP/SoP)

  Day 1

Study Arms (2)

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.

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.
• Willingness to comply with all study procedures required by the protocol. In addition, participants must meet the criteria for one of the following study groups:
• Peri-implantitis Group:
• Diagnosis of peri-implantitis according to the diagnostic criteria established at the 2017 World Workshop on the Classification of Periodontal and Peri- Implant Diseases and Conditions.
• Candidate for surgical or non-surgical peri-implantitis treatment involving the collection of peri-implant granulation tissue and/or biofilm samples.
• Control Group:
• Candidate for implant therapy, with the placement of at least one dental implant included in the treatment plan.
• Candidate for implant placement using a static computer-guided surgical approach.
• Availability of soft tissue from the implant recipient site for sample collection (≥ 3 mm).

You may not qualify if:

• Patients who, in the investigator's judgement, are not suitable candidates for participation in the study based on their medical history, physical examination findings, concomitant medications, or concurrent systemic conditions:
• Presence of uncontrolled periodontal disease, defined as probing depths
• ≥5 mm with concomitant bleeding on probing or probing depths ≥6 mm.
• Immunocompromised patients.
• History of radiotherapy or chemotherapy.
• Presence of uncontrolled systemic diseases.
• Presence of systemic conditions known to affect bone metabolism.
• Current treatment with medications known to alter bone metabolism.
• History of oral cancer.
• Use of systemic antibiotics within the previous 6 months.
• Current smokers consuming ≥20 cigarettes per day.
• History of drug or alcohol abuse. For the purposes of this study, alcohol abuse is defined as the habitual consumption of more than four units of alcohol per day (one unit being approximately equivalent to 125 mL of wine, 200 mL of beer, or 25 mL of spirits).
• Participation in any other clinical study within the 4 weeks preceding enrolment.
• Surgical or non-surgical peri-implantitis treatment at the selected implant site within the 12 months preceding enrolment.
• Pregnant or breastfeeding women.

Sponsors & Collaborators

• University of Barcelona: lead
• Universidad de Oviedo: collaborator
• Universidad de Zaragoza: collaborator
• Universitat Autonoma de Barcelona: collaborator
• Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz: collaborator

Related Links

• Hospital Odontològic Universitat de Barcelona

Biospecimen

Retention: SAMPLES WITH DNA

The retained biospecimens will include: 1. Granulation tissue collected from the most affected implant of patients in the peri-implantitis group. 2. Submucosal biofilm collected from the deepest peri-implant site of the selected implant of patients in the peri-implantitis group. 3. Healthy gingival tissue collected from the planned implant site in the active control group before implant placement.

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Central Study Contacts

Octavi Camps Font, DDS MS PhD

CONTACT

+34 934 024 269; ocamps@ub.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: August 20, 2026
• First Posted: August 28, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): September 3, 2027
• Study Completion (Estimated): March 30, 2028
• Last Updated: August 28, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share