[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655497":3},{"organization":4,"outcomesModule":7,"designInfo":35,"detailedDescription":45,"studyPopulation":34,"armGroups":46,"interventions":73,"overallOfficials":34,"centralContacts":103,"locations":34,"responsibleParty":113,"collaborators":117,"id":121,"slug":122,"hasResults":123,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":34,"eligibilityCriteria":127,"healthyVolunteers":128,"sex":129,"minAge":130,"maxAge":34,"enrollmentInfo":131,"targetDuration":34,"studyType":134,"phases":135,"briefSummary":137,"conditions":138,"keywords":140,"overallStatus":146,"whyStopped":34,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":34},{"fullName":5,"class":6},"Saglik Bilimleri Universitesi","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":34},[9],{"measure":10,"description":11,"timeFrame":12},"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.","Baseline (T0), 24 hours post-treatment (T1), and 6 weeks post-treatment (T2)",[14,18,21,24,27,30],{"measure":15,"description":16,"timeFrame":17},"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.","Baseline (T0) and 6 weeks post-treatment (T2)",{"measure":19,"description":20,"timeFrame":17},"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.",{"measure":22,"description":23,"timeFrame":17},"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.",{"measure":25,"description":26,"timeFrame":17},"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.",{"measure":28,"description":29,"timeFrame":17},"Change in Clinical Attachment Level (CAL)","Quantification of the distance from a fixed anatomical or prosthetic reference point (such as the implant shoulder or crown margin) to the base of the pocket, serving as an indicator of supporting tissue status.",{"measure":31,"description":32,"timeFrame":33},"Change in Multi-Element Trace Metal Concentrations in Inflammatory Granulation Tissue","Quantitative elemental analysis of multi-element trace metal levels (Ti, Al, V, Co, Cr, Cu, Zr, Fe, Ni, As, Pb) in inflammatory granulation tissue samples collected during debridement (or via gentle sulcular sampling for non-contact groups) using Inductively Coupled Plasma Mass Spectrometry (ICP-MS) following microwave-assisted acid digestion.","Only at baseline (T0) during debridement",null,{"allocation":36,"interventionModel":37,"interventionModelDescription":38,"primaryPurpose":39,"observationalModel":34,"timePerspective":34,"maskingInfo":40},"RANDOMIZED","PARALLEL","This study utilizes a parallel assignment design comprising five distinct study groups, consisting of four active treatment arms for peri-implantitis and one healthy control arm. Participants diagnosed with peri-implantitis will be randomly allocated to one of four parallel non-surgical decontamination groups using computer-generated block randomization via the sequentially numbered opaque sealed envelope (SNOSE) method. An additional cohort of individuals with healthy implants will serve as a non-intervention control group to establish baseline comparative parameters for metal ion release and clinical evaluations.","TREATMENT",{"masking":41,"maskingDescription":42,"whoMasked":43},"SINGLE","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.\n\nTo 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.",[44],"OUTCOMES_ASSESSOR","Background and Rationale:\n\nPeri-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.\n\nObjectives and Hypotheses:\n\nThe 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.\n\nStudy Design and Patient Population:\n\nThis study is designed as a prospective, randomized, controlled, single-blind, in vivo clinical and laboratory trial. A total of 70 implants will be evaluated: 56 peri-implantitis implants and 14 healthy control implants. Peri-implantitis cases will be randomly allocated using computer-generated block randomization via the sequentially numbered opaque sealed envelope (SNOSE) method into four parallel treatment groups (14 implants per group):\n\nGroup 1 (Titanium Curette): Mechanical debridement using titanium curettes (10-15 strokes per surface horizontally and apico-coronally).\n\nGroup 2 (Plastic Curette): Mechanical debridement using implant-compatible plastic curettes adhering to the same stroke and directional principles.\n\nGroup 3 (Diode Laser): Diode laser application (940 nm, 1 W average power, non-contact mode, 300 µm fiber tip for 60 seconds).\n\nGroup 4 (EMS Air-Flow + PEEK): Guided Biofilm Therapy (GBT) protocol utilizing submarginal erythritol powder via PerioFlow nozzle, followed by a PEEK instrument (Piezon PI) to remove remaining calcified deposits.\n\nGroup 5 (Healthy Control): Individuals with peri-implant health receiving no treatment intervention, undergoing clinical monitoring and PISF collection only.\n\nProcedures and Assessments:\n\nClinical Parameters: Probing Depth (PD), Bleeding on Probing (BoP), Plaque Index (PI), Gingival Index (GI), and Clinical Attachment Level (CAL) will be recorded at baseline (T0) and at 6 weeks (T2) by a blinded and calibrated investigator. PISF Sampling: Peri-implant sulcular fluid samples will be collected using sterile paper strips (Periopaper) at baseline (T0), 24 hours post-treatment (T1), and 6 weeks post-treatment (T2). Fluid volume will be measured via Periotron and stored at -80°C.\n\nGranulation Tissue Sampling: Inflammatory granulation tissue samples will be collected during debridement (or via gentle sulcular sampling for laser and air-flow groups, strictly avoiding contact with the titanium surface) and placed in sterile eppendorf tubes.\n\nICP-MS Analysis: Biological samples will undergo microwave-assisted acid digestion and quantitative elemental analysis (Ti, Al, V, Co, Cr, Cu, Zr, Fe, Ni, As, Pb) using Inductively Coupled Plasma Mass Spectrometry (ICP-MS) at an accredited laboratory. Baseline metal loads of materials (such as erythritol powder and blank Periopaper strips) will be accounted for and subtracted.",[47,53,58,63,68],{"label":48,"type":49,"description":50,"interventionNames":51},"Arm 1: Titanium Curette Group","EXPERIMENTAL","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.",[52],"Device: Mechanical Debridement with Titanium Curettes",{"label":54,"type":49,"description":55,"interventionNames":56},"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.",[57],"Device: Mechanical Debridement with Plastic Curettes",{"label":59,"type":49,"description":60,"interventionNames":61},"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.",[62],"Device: 940 nm Diode Laser Decontamination",{"label":64,"type":49,"description":65,"interventionNames":66},"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.",[67],"Device: Submarginal Erythritol Air-Polishing and PEEK Instrumentation",{"label":69,"type":6,"description":70,"interventionNames":71},"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.",[72],"Other: Clinical Observation and Sampling Only from Healthy implants",[74,81,87,93,99],{"type":75,"name":76,"description":77,"armGroupLabels":78,"otherNames":79},"DEVICE","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.",[48],[80],"Non-surgical Peri-implantitis treatment with Titanium Curettes",{"type":75,"name":82,"description":83,"armGroupLabels":84,"otherNames":85},"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.",[54],[86],"Non-surgical Peri-implantitis treatment with Plastic Curettes",{"type":75,"name":88,"description":89,"armGroupLabels":90,"otherNames":91},"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.",[59],[92],"Laser-Assisted Decontamination Protocol",{"type":75,"name":94,"description":95,"armGroupLabels":96,"otherNames":97},"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.",[64],[98],"Peri-implantitis Guided Biofilm Therapy (GBT) Protocol",{"type":6,"name":100,"description":101,"armGroupLabels":102,"otherNames":34},"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.",[69],[104,109],{"name":105,"role":106,"phone":107,"phoneExt":34,"email":108},"Özlem SARAÇ ATAGÜN, DDS, Assoc. Prof.","CONTACT","+905055096482","ozlemsarac2806@hotmail.com",{"name":110,"role":106,"phone":111,"phoneExt":34,"email":112},"İrem Sezen, DDS, PhD Candidate","+905426982624","iremszn@gmail.com",{"type":114,"investigatorFullName":115,"investigatorTitle":116,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"PRINCIPAL_INVESTIGATOR","Özlem SARAÇ ATAGÜN","Assoc. Prof. Dr.",[118],{"name":119,"class":120},"Health Sciences University-Scientific Research Projects Unit","UNKNOWN","100655497","titanium-particle-release-across-non-surgical-peri-implantitis-therapies-100655497",false,"NCT07811921","Titanium Particle Release Across Non-Surgical Peri-implantitis Therapies","Evaluation of the Effects of Peri-implantitis Treatment Approaches on Titanium Particle Release","Inclusion Criteria:\n\n* Being systemically healthy and older than 18 years of age.\n* 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).\n* Dental implants being in function in the oral cavity for at least 1 year.\n\nExclusion Criteria:\n\n* Having received systemic antibiotic therapy within the past 3 months.\n* Having previously received peri-implantitis treatment at the relevant implant site.\n* Being pregnant or lactating.",true,"ALL","18 Years",{"count":132,"type":133},70,"ESTIMATED","INTERVENTIONAL",[136],"NA","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.",[139],"Peri-implantitis",[139,141,142,143,144,145],"Titanium particle release","Non-surgical peri-implantitis treatment","Decontamination methods","Inductively Coupled Plasma Mass Spectrometry (ICP-MS)","Peri-implant sulcular fluid","NOT_YET_RECRUITING","2026-09-04",{"date":149,"type":150},"2026-09-10","ACTUAL",{"date":152,"type":133},"2026-10-15",{"date":154,"type":133},"2027-06-15",{"name":5,"class":6}]