Evaluation of the Effects of Peri-implantitis Treatment Approaches on Titanium Particle Release
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 主要终点
- Change in Multi-Element Trace Metal Concentrations (Titanium Ion Release) in Peri-Implant Sulcular Fluid (PISF)
研究概览
简要总结
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.
详细描述
Background and Rationale:
Peri-implantitis is a multifactorial inflammatory disease characterized by inflammation in the peri-implant soft tissues and progressive loss of supporting crestal bone. Non-surgical treatment protocols primarily aim to eliminate pathogenic bacterial biofilm and reduce local inflammation. However, mechanical forces and physical methods applied during these procedures can cause micro- and macro-level surface alterations on dental implants, leading to the release of metallic micro- and nanoparticles into the surrounding tissues. These released metal ions and particles can trigger foreign body reactions, macrophage polarization, and elevated cytokine expression, thereby exacerbating bone resorption independently of the biofilm. Although various non-surgical decontamination methods are clinically utilized, data evaluating their short- and medium-term metal release kinetics alongside clinical outcomes through prospective in vivo designs remain limited.
Objectives and Hypotheses:
The primary objective of this study is to prospectively compare the clinical efficacy of four different non-surgical decontamination methods and to quantitatively assess their impact on multi-element trace metal release (Ti, Al, V, Co, Cr, Cu, Zr, Fe, Ni, As, Pb) in peri-implant sulcular fluid (PISF) and granulation tissue. The study will test hypotheses regarding whether different treatment modalities create significant differences in clinical parameters (Probing Depth, Plaque Index, Bleeding on Probing, Gingival Index, Clinical Attachment Level) and metal ion load, while determining the most biocompatible and minimally invasive protocol.
Study Design and Patient Population:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
This single-blind study maintains blinding specifically for the clinical outcomes assessor to minimize detection bias. Due to the distinct physical and operational nature of the interventional devices utilized-including titanium curettes, plastic curettes, diode lasers, and air-flow systems-complete blinding of the treating clinician and the study participants is not feasible.
To safeguard study integrity, all clinical parameter evaluations-including Probing Depth (PD), Bleeding on Probing (BoP), Plaque Index (PI), Gingival Index (GI), and Clinical Attachment Level (CAL) recorded at baseline (T0) and 6 weeks (T2)-will be performed exclusively by an independent, calibrated examiner (specialist physician) who remains strictly blinded to the group allocations and treatment protocols. Additionally, laboratory technicians performing the Inductively Coupled Plasma Mass Spectrometry (ICP-MS) elemental analyses will be blinded to the group identities of the biological samples.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Mechanical Debridement with Titanium Curettes (Device)
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.
干预措施: Mechanical Debridement with Plastic Curettes (Device)
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.
干预措施: 940 nm Diode Laser Decontamination (Device)
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.
干预措施: Submarginal Erythritol Air-Polishing and PEEK Instrumentation (Device)
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.
干预措施: Clinical Observation and Sampling Only from Healthy implants (Other)
结局指标
主要结局
Change in Multi-Element Trace Metal Concentrations (Titanium Ion Release) in Peri-Implant Sulcular Fluid (PISF)
时间窗: Baseline (T0), 24 hours post-treatment (T1), and 6 weeks post-treatment (T2)
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.
次要结局
- Change in Probing Depth (PD)(Baseline (T0) and 6 weeks post-treatment (T2))
- Change in Bleeding on Probing (BoP)(Baseline (T0) and 6 weeks post-treatment (T2))
- Change in Plaque Index (PI)(Baseline (T0) and 6 weeks post-treatment (T2))
- Change in Gingival Index (GI)(Baseline (T0) and 6 weeks post-treatment (T2))
- Change in Clinical Attachment Level (CAL)(Baseline (T0) and 6 weeks post-treatment (T2))
- Change in Multi-Element Trace Metal Concentrations in Inflammatory Granulation Tissue(Only at baseline (T0) during debridement)
研究者
Özlem SARAÇ ATAGÜN
Assoc. Prof. Dr.
Saglik Bilimleri Universitesi