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Titanium Particle Release Across Non-Surgical Peri-implantitis Therapies

ConditionPeri-implantitis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSaglik Bilimleri Universitesi

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Being systemically healthy and older than 18 years of age.

Having implants diagnosed with peri-implantitis according to the 2017 World Workshop criteria (probing depth ≥ 5 mm, bleeding on probing positive, radiographic bone loss > 2 mm).

Dental implants being in function in the oral cavity for at least 1 year.

Disqualifiers

Having received systemic antibiotic therapy within the past 3 months.

Having previously received peri-implantitis treatment at the relevant implant site.

Being pregnant or lactating.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

    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.

Treatment groups

70 Participants
are divided into 5 treatment groups
Group A: Arm 1: Titanium Curette GroupExperimental treatment 1 intervention
Group B: Arm 2: Plastic Curette GroupExperimental treatment 1 intervention
Group C: Arm 3: Diode Laser GroupExperimental treatment 1 intervention
Group D: Arm 4: EMS Air-Flow + PEEK GroupExperimental treatment 1 intervention
Group E: Arm 5: Healthy Control GroupOther 1 intervention

Trial outcomes

Primary outcomes

1

Change in Multi-Element Trace Metal Concentrations (Titanium Ion Release) in Peri-Implant Sulcular Fluid (PISF)

Quantitative analysis of multi-element trace metal concentrations-specifically Titanium (Ti) along with Al, V, Co, Cr, Cu, Zr, Fe, Ni, As, and Pb-released into the peri-implant sulcular fluid (PISF). PISF samples will be collected using sterile Periopaper strips, quantified via Periotron, stored at -80°C, and analyzed using Inductively Coupled Plasma Mass Spectrometry (ICP-MS) following microwave-assisted acid digestion, subtracting baseline material blanks.

Time frame
Baseline (T0), 24 hours post-treatment (T1), and 6 weeks post-treatment (T2)

Secondary outcomes

1

Change in Probing Depth (PD)

Assessment of peri-implant pocket depth reduction measured in millimeters using a standardized periodontal probe from the mucosal margin to the base of the peri-implant pocket. All measurements will be recorded by a blinded and calibrated investigator.

Time frame
Baseline (T0) and 6 weeks post-treatment (T2)
2

Change in Bleeding on Probing (BoP)

Evaluation of mucosal inflammation around the dental implants, recorded dichotomously as the presence or absence of bleeding within 30 seconds following gentle probing of the peri-implant sulcus.

Time frame
Baseline (T0) and 6 weeks post-treatment (T2)
3

Change in Plaque Index (PI)

Quantification of microbial plaque accumulation and oral hygiene status surrounding the dental implant sites, evaluated using standardized clinical scoring criteria.

Time frame
Baseline (T0) and 6 weeks post-treatment (T2)
4

Change in Gingival Index (GI)

Assessment of the severity of peri-implant mucosal inflammation based on visual characteristics and tissue response to mild probing around the implant perimeter.

Time frame
Baseline (T0) and 6 weeks post-treatment (T2)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Saglik Bilimleri Universitesi

Lead sponsor

Health Sciences University-Scientific Research Projects Unit

Collaborator

Source ClinicalTrials.gov

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