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Titanium Particle Release Across Non-Surgical Peri-implantitis Therapies
Sponsor: Saglik Bilimleri Universitesi
Summary
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.
Official title: Evaluation of the Effects of Peri-implantitis Treatment Approaches on Titanium Particle Release
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
70
Start Date
2026-10-15
Completion Date
2027-06-15
Last Updated
2026-09-10
Healthy Volunteers
Yes
Conditions
Interventions
Mechanical Debridement with Titanium Curettes
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
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
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
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
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.