Peri-implantitisNCT07811921
Titanium Particle Release Across Non-Surgical Peri-implantitis Therapies
A study testing Mechanical Debridement with Titanium Curettes, Mechanical Debridement with Plastic Curettes and 940 nm Diode Laser Decontamination in people with Peri-implantitis, run by Saglik Bilimleri Universitesi.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peri-implantitis
- What is being tested?
- Mechanical Debridement with Titanium Curettes, Mechanical Debridement with Plastic Curettes and 940 nm Diode Laser Decontamination
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2026to 15 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of the Effects of Peri-implantitis Treatment Approaches on Titanium Particle Release
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.
Read the detailed description
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:
This 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):
Group 1 (Titanium Curette): Mechanical debridement using titanium curettes (10-15 strokes per surface horizontally and apico-coronally).
Group 2 (Plastic Curette): Mechanical debridement using implant-compatible plastic curettes adhering to the same stroke and directional principles.
Group 3 (Diode Laser): Diode laser application (940 nm, 1 W average power, non-contact mode, 300 µm fiber tip for 60 seconds).
Group 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.
Group 5 (Healthy Control): Individuals with peri-implant health receiving no treatment intervention, undergoing clinical monitoring and PISF collection only.
Procedures and Assessments:
Clinical 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.
Granulation 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.
ICP-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.
- Conditions
- Peri-implantitis
- Being tested
- Mechanical Debridement with Titanium Curettes, Mechanical Debridement with Plastic Curettes, 940 nm Diode Laser Decontamination, Submarginal Erythritol Air-Polishing and PEEK Instrumentation, Clinical Observation and Sampling Only from Healthy implants
- Keywords
- Peri-implantitis, Titanium particle release, Non-surgical peri-implantitis treatment, Decontamination methods, Inductively Coupled Plasma Mass Spectrometry (ICP-MS), Peri-implant sulcular fluid
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical Debridement with Titanium CurettesDevice
Also called Non-surgical Peri-implantitis treatment 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 CurettesDevice
Also called Non-surgical Peri-implantitis treatment 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 DecontaminationDevice
Also called Laser-Assisted Decontamination Protocol
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 InstrumentationDevice
Also called Peri-implantitis Guided Biofilm Therapy (GBT) Protocol
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 implantsOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Mechanical Debridement with Titanium Curettes |
| Arm 2: Plastic Curette Group | Experimental | 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. Receives: Device: Mechanical Debridement with Plastic Curettes |
| Arm 3: Diode Laser Group | Experimental | 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. Receives: Device: 940 nm Diode Laser Decontamination |
| Arm 4: EMS Air-Flow + PEEK Group | Experimental | 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. Receives: Device: Submarginal Erythritol Air-Polishing and PEEK Instrumentation |
| Arm 5: Healthy Control Group | Other | 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. Receives: Other: Clinical Observation and Sampling Only from Healthy implants |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (T0), 24 hours post-treatment (T1), and 6 weeks post-treatment (T2)
Secondary outcomes (6)
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.
Measured: Baseline (T0) and 6 weeks post-treatment (T2)
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.
Measured: Baseline (T0) and 6 weeks post-treatment (T2)
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.
Measured: Baseline (T0) and 6 weeks post-treatment (T2)
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.
Measured: Baseline (T0) and 6 weeks post-treatment (T2)
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.
Measured: Baseline (T0) and 6 weeks post-treatment (T2)
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.
Measured: Only at baseline (T0) during debridement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start15 Oct 2026 (estimated)
- Primary completion15 Apr 2027 (estimated)
- Study completion15 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri-implantitisStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Collaborators
- Health Sciences University-Scientific Research Projects Unit
- Responsible party
- Principal investigator, Özlem SARAÇ ATAGÜN, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07811921
- Sponsor's protocol ID
- OSATAGUN6
- Other IDs
- Secondary ID 2026/290
- Status last verified
- Sep 2026
- First submitted
- 3 Sep 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Peri-implantitis Treatment Approaches on Titanium Particle Release
- ClinicalTrials.gov ID
- NCT07811921
- Acronym / sponsor ID
- OSATAGUN6
- Conditions
- Peri-implantitis
- Keywords
- Peri-implantitis, Titanium particle release, Non-surgical peri-implantitis treatment, Decontamination methods, Inductively Coupled Plasma Mass Spectrometry (ICP-MS), Peri-implant sulcular fluid
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Collaborators
- Health Sciences University-Scientific Research Projects Unit
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 15 Apr 2027 (estimated)
- Study completion
- 15 Jun 2027 (estimated)
- First posted
- 10 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
This 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):
Group 1 (Titanium Curette): Mechanical debridement using titanium curettes (10-15 strokes per surface horizontally and apico-coronally).
Group 2 (Plastic Curette): Mechanical debridement using implant-compatible plastic curettes adhering to the same stroke and directional principles.
Group 3 (Diode Laser): Diode laser application (940 nm, 1 W average power, non-contact mode, 300 µm fiber tip for 60 seconds).
Group 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.
Group 5 (Healthy Control): Individuals with peri-implant health receiving no treatment intervention, undergoing clinical monitoring and PISF collection only.
Procedures and Assessments:
Clinical 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.
Granulation 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.
ICP-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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Titanium Curette Group | Experimental | Device: Mechanical Debridement with Titanium CurettesMechanical 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. |
| Arm 2: Plastic Curette Group | Experimental | Device: Mechanical Debridement with Plastic CurettesMechanical 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. |
| Arm 3: Diode Laser Group | Experimental | Device: 940 nm Diode Laser DecontaminationLaser-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. |
| Arm 4: EMS Air-Flow + PEEK Group | Experimental | Device: Submarginal Erythritol Air-Polishing and PEEK InstrumentationA 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. |
| Arm 5: Healthy Control Group | Other | Other: Clinical Observation and Sampling Only from Healthy implantsIndividuals 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mechanical Debridement with Titanium CurettesAlso: Non-surgical Peri-implantitis treatment with Titanium CurettesThis 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. | Device | Arm 1: Titanium Curette Group |
| Mechanical Debridement with Plastic CurettesAlso: Non-surgical Peri-implantitis treatment with Plastic CurettesThis 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. | Device | Arm 2: Plastic Curette Group |
| 940 nm Diode Laser DecontaminationAlso: Laser-Assisted Decontamination ProtocolThis 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. | Device | Arm 3: Diode Laser Group |
| Submarginal Erythritol Air-Polishing and PEEK InstrumentationAlso: Peri-implantitis Guided Biofilm Therapy (GBT) ProtocolThis 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. | Device | Arm 4: EMS Air-Flow + PEEK Group |
| Clinical Observation and Sampling Only from Healthy implantsThis 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. | Other | Arm 5: Healthy Control Group |
Primary outcome
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)
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.
6 secondary outcomes
Change in Probing Depth (PD)
Time frame: Baseline (T0) and 6 weeks post-treatment (T2)
Change in Bleeding on Probing (BoP)
Time frame: Baseline (T0) and 6 weeks post-treatment (T2)
Change in Plaque Index (PI)
Time frame: Baseline (T0) and 6 weeks post-treatment (T2)
Change in Gingival Index (GI)
Time frame: Baseline (T0) and 6 weeks post-treatment (T2)
Change in Clinical Attachment Level (CAL)
Time frame: Baseline (T0) and 6 weeks post-treatment (T2)
Change in Multi-Element Trace Metal Concentrations in Inflammatory Granulation Tissue
Time frame: Only at baseline (T0) during debridement
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Mechanical Debridement with Titanium Curettes, Mechanical Debridement with Plastic Curettes and 940 nm Diode Laser Decontamination in people with Peri-implantitis, run by Saglik Bilimleri Universitesi.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Özlem SARAÇ ATAGÜN, DDS, Assoc. Prof. (+905055096482, ozlemsarac2806@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.