Titanium Particle Release Across Non-Surgical Peri-implantitis Therapies

Sponsor
Saglik Bilimleri Universitesi
Study ID
NCT07811921
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

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

Interventions

  • Mechanical Debridement with Titanium Curettes — DEVICE
    This arm evaluates standard mechanical debridement using medical-grade titanium curettes, applied as 10-15 systematic strokes per implant surface horizontally and apico-coronally. Unlike conventional studies that focus solely on clinical indices, this protocol uniquely combines mechanical cleaning with quantitative Inductively Coupled Plasma Mass Spectrometry (ICP-MS) analysis to measure multi-element trace metal release (Ti, Al, V, Co, Cr, Cu, Zr, Fe, Ni, As, Pb) in both peri-implant sulcular fluid (PISF) and inflammatory granulation tissue, determining the specific particulate load generated by metallic curettage.
  • Mechanical Debridement with Plastic Curettes — DEVICE
    This arm utilizes implant-compatible, flexible plastic curettes adhering to identical stroke parameters (10-15 strokes per surface horizontally and apico-coronally). Its unique methodological value lies in comparing polymer-based mechanical instrumentation against metallic counterparts, specifically quantifying whether non-metallic mechanical debridement mitigates multi-element trace metal release (analyzed via ICP-MS across 11 elemental parameters in PISF and granulation tissue) while maintaining therapeutic clinical efficacy in peri-implantitis management.
  • 940 nm Diode Laser Decontamination — DEVICE
    This arm implements a laser-assisted decontamination protocol using a 940 nm diode laser operated in non-contact mode at an average power of 1 W with a 300 µm fiber tip applied for 60 seconds per surface. This intervention investigates the thermal and bactericidal efficacy of optical decontamination, uniquely pairing it with high-precision ICP-MS trace metal quantification (Ti, Al, V, Co, Cr, Cu, Zr, Fe, Ni, As, Pb) from PISF and granulation tissue samples to evaluate whether photon-based decontamination induces surface alterations or ion shedding compared to mechanical modalities.
  • Submarginal Erythritol Air-Polishing and PEEK Instrumentation — DEVICE
    This arm employs a two-step Guided Biofilm Therapy (GBT) protocol combining submarginal air-polishing with erythritol powder via a PerioFlow nozzle followed by a medical-grade PEEK (Piezon PI) instrument for hard deposit removal. This advanced combination protocol is uniquely designed to eliminate biofilm without scarring the titanium surface, its safety and efficacy rigorously validated through quantitative multi-element ICP-MS analysis of 11 trace metals in PISF and granulation tissue samples collected at baseline, 24 hours, and 6 weeks.
  • Clinical Observation and Sampling Only from Healthy implants — OTHER
    This non-intervention control cohort comprises individuals with clinically healthy dental implants who receive no surgical or therapeutic decontamination. It serves as a vital comparative baseline for the study, allowing researchers to evaluate physiological baseline levels of multi-element trace metal concentrations (Ti, Al, V, Co, Cr, Cu, Zr, Fe, Ni, As, Pb) in PISF and tissue samples relative to diseased, treated implant sites without confounding therapeutic variables.

Study Details

This prospective, randomized, controlled, single-blind, in vivo clinical and laboratory study aims to quantitatively compare the clinical success and metal ion release associated with four different non-surgical decontamination methods in the management of peri-implantitis. A total of 70 implants (56 peri-implantitis implants divided into four treatment groups, and 14 healthy control implants) will be included. Clinical parameters will be evaluated at baseline and 6 weeks, and multi-element trace metal levels (Ti, Al, V, Co, Cr, Cu, Zr, Fe, Ni, As, Pb) in peri-implant sulcular fluid (PISF) and granulation tissue will be analyzed using Inductively Coupled Plasma Mass Spectrometry (ICP-MS) at baseline, 24 hours, and 6 weeks.

Key Dates

First listed
Sep 10, 2026
Start date
Oct 15, 2026
Status verified
Sep 2026
Primary completion
Apr 15, 2027
Completion
Jun 15, 2027

Study Design

Enrollment
70 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1: Titanium Curette Group
    Mechanical debridement performed using specialized medical-grade titanium curettes. The treatment protocol involves applying 10-15 systematic strokes per implant surface in both horizontal and apico-coronal directions to thoroughly decontaminate the infected implant threads and remove subgingival biofilm and calculus.
  • Experimental: Arm 2: Plastic Curette Group
    Mechanical debridement performed using implant-compatible, flexible plastic curettes. The procedure strictly adheres to the same standardized stroke count and directional mechanics (10-15 strokes per surface horizontally and apico-coronally) to minimize aggressive surface scratching while eliminating bacterial plaque.
  • Experimental: Arm 3: Diode Laser Group
    Laser-assisted surface decontamination utilizing a diode laser system operating at a wavelength of 940 nm. The protocol is administered in a non-contact mode with an average power of 1 W, utilizing a 300 µm fiber tip applied for 60 seconds per implant surface to achieve bactericidal and decontamination effects.
  • Experimental: Arm 4: EMS Air-Flow + PEEK Group
    A two-step Guided Biofilm Therapy (GBT) approach. First, submarginal air-polishing is performed using erythritol powder delivered via a specialized PerioFlow nozzle to remove soft biofilm. Second, residual hard deposits are carefully cleared using a medical-grade PEEK (Polyetheretherketone) instrument (Piezon PI) designed to prevent titanium surface scarring.
  • Other: Arm 5: Healthy Control Group
    Individuals presenting with healthy peri-implant tissues who receive no therapeutic or surgical decontamination intervention. This cohort serves as a non-intervention control group to establish baseline comparative values for clinical metrics, peri-implant sulcular fluid (PISF) volume, and multi-element trace metal concentrations.

Primary Outcome Measure

Change in Multi-Element Trace Metal Concentrations (Titanium Ion Release) in Peri-Implant Sulcular Fluid (PISF) [ Time Frame: Baseline (T0), 24 hours post-treatment (T1), and 6 weeks post-treatment (T2) ]

Central Contacts

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