Peri-ImplantitisNCT06890117
Non-Surgical Laser Treatment for Peri-Implantitis: Er:YAG & Diode Laser
A study testing Ultrasonic Scalers with EMS PI tip and Saline Irrigation and Er:YAG (2940nm) and Diode (808nm) Laser in people with Peri-Implantitis, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial summary
A prospective, randomized clinical trial with a 3-month duration was designed to evaluate the efficacy of non-surgical treatment for peri-implantitis. Patients presenting at the Postgraduate Periodontology Clinic of the School of Dentistry, Aristotle University of Thessaloniki, with a diagnosis of peri-implantitis in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peri-Implantitis
- What is being tested?
- Ultrasonic Scalers with EMS PI tip and Saline Irrigation and Er:YAG (2940nm) and Diode (808nm) Laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGreece
- Study dates
- 30 Jan 2025to 5 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients presenting at the Postgraduate Periodontology Clinic with a diagnosis of peri-implantitis in at least one implant, based on the 2018 Classification of Periodontal and Peri-Implant Diseases (EFP 2018).
- Probing pocket depth (PPD) of up to 10 mm.
- Periodontally healthy individuals (no active periodontal disease).
- Implants must have been in function (loaded) for at least one year.
- Age ≥ 18 years.
- Medically healthy individuals or those with well-controlled systemic conditions.
Show all 9Show fewer
- Implant-supported restorations must be accessible for proper oral hygiene.
- Patients must provide signed informed consent for participation.
- Non-smokers only
Who cannot join
- Presence of systemic diseases or medications that could influence treatment outcomes (e.g., uncontrolled diabetes, chemotherapy, immunosuppression).
- Underwent peri-implantitis treatment in the past 3 months.
- Use of antibiotics or antimicrobial therapy in the past 3 months.
- Pregnancy or breastfeeding.
- Smokers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-surgical Treatment of Peri-implantitis Using Combined Er: YAG (2940nm) and Diode Laser (808nm): a Randomized Controlled Clinical Trial. Clinical, Microbiological Parameters and Metabolomics
A prospective, randomized clinical trial with a 3-month duration was designed to evaluate the efficacy of non-surgical treatment for peri-implantitis. Patients presenting at the Postgraduate Periodontology Clinic of the School of Dentistry, Aristotle University of Thessaloniki, with a diagnosis of peri-implantitis in at least one implant (based on the new classification of periodontal and peri-implant diseases, EFP 2018) will be included.
After clinical and radiographic evaluation, patients will be randomly assigned to two groups, with each patient participating in the study with one implant. The control group will receive non-surgical treatment using ultrasonic scalers designed for implants, combined with saline irrigation. The experimental group will undergo non-surgical treatment with Er:YAG (2940nm) and Diode (808nm) laser. All patients will receive oral hygiene instructions at baseline and during each subsequent visit.
Read more
Microbial plaque samples will be collected using two sterile paper cones from the deepest peri-implant pocket before treatment and three months after treatment. The presence and absolute counts of Porphyromonas gingivalis and Filifactor alocis will be assessed using quantitative polymerase chain reaction (qPCR). Additionally, peri-implant crevicular fluid will be collected from the second deepest peri-implant pocket using three sterile paper cones before treatment and three months post-treatment for metabolomic analysis.
Clinical parameters, including probing pocket depth (PPD), bleeding on probing (BOP), clinical attachment level (CAL), peri-implant mucosal recession (REC), and suppuration (SUP), will be recorded at baseline and at the end of the experimental period (3 months). Treatment success will be evaluated at the 3-month mark, defined as a pocket depth ≤5 mm with no bleeding on probing at more than one of six implant sites and no suppuration, according to the EFP S3 level clinical practice guideline.
Additionally, patients will complete a home questionnaire to assess pain at different time points (immediately after treatment, 24, 48, and 72 hours post-treatment). Pain levels will be evaluated using a 100-mm visual analog scale (VAS), where 0 mm indicates "no pain" and 100 mm represents "worst pain." The total number of analgesics consumed daily for one week post-treatment will also be recorded. At the end of the week, patients will answer four Yes/No/Don't Know questions to assess their satisfaction with the treatment.
Read the detailed description
This study aims to compare the effectiveness of non-surgical peri-implantitis treatment using conventional ultrasonic debridement versus a laser-assisted approach. The primary objective is to assess clinical, microbiological, and metabolomic outcomes associated with each treatment modality.
The study will be conducted at the Postgraduate Periodontology Clinic of the School of Dentistry, Aristotle University of Thessaloniki. Participants will be screened based on inclusion and exclusion criteria, and those diagnosed with peri-implantitis in at least one implant will be randomly assigned to either the control or experimental group.
Study Procedures:
Control Group: Treatment with ultrasonic scalers designed for implants and saline irrigation.
Experimental Group: Treatment with Er:YAG (2940nm) and Diode (808nm) laser.
Oral Hygiene Instructions: Provided at baseline and each follow-up visit.
Microbiological Sampling: Collection of subgingival plaque using sterile paper cones before and after treatment (3 months), with analysis of P. gingivalis and F. alocis using qPCR.
Metabolomic Analysis: Collection of peri-implant crevicular fluid before and after treatment for metabolomic profiling.
Clinical Parameters: PPD, BOP, CAL, REC, and SUP will be recorded at baseline and after 3 months.
Pain and Patient Satisfaction: VAS pain assessment at multiple time points and tracking of analgesic consumption. A patient satisfaction questionnaire will be completed at the end of the study.
Study Outcomes:
Primary Outcome: Reduction in peri-implant pocket depth and inflammation.
Secondary Outcomes: Changes in microbiological and metabolomic markers, pain perception, and patient-reported satisfaction.
This randomized controlled clinical trial aims to provide valuable insights into the efficacy of laser-assisted non-surgical therapy for peri-implantitis compared to conventional ultrasonic debridement. The findings could contribute to the optimization of non-surgical treatment protocols for peri-implant disease management.
- Conditions
- Peri-Implantitis
- Being tested
- Ultrasonic Scalers with EMS PI tip and Saline Irrigation, Er:YAG (2940nm) and Diode (808nm) Laser
- Keywords
- Non-surgical therapy, Er:YAG laser, Diode laser, Microbiological analysis, Metabolomics, RCT
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonic Scalers with EMS PI tip and Saline IrrigationDevice
Also called Ultrasonic Debridement
Control Group: Non-surgical peri-implantitis treatment using ultrasonic scalers and EMS PI tips designed for implants, combined with saline irrigation to remove plaque and biofilm from implant surfaces.
Er:YAG (2940nm) and Diode (808nm) LaserDevice
Also called Laser-Assisted Peri-Implantitis Treatment
Experimental Group: Non-surgical peri-implantitis treatment using Er:YAG laser (2940nm) and Diode laser (808nm) for decontamination of the implant surface and surrounding tissues. The Er:YAG laser is used for mechanical debridement and biofilm removal, while the Diode laser has biostimulatory effects.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasonic Debridement + Saline Irrigation | Active comparator | Participants in this group will receive non-surgical mechanical debridement using ultrasonic scalers specifically designed for implant surfaces, followed by irrigation with saline solution. No additional laser therapy will be applied. Receives: Device: Ultrasonic Scalers with EMS PI tip and Saline Irrigation |
| Er:YAG + Diode Laser | Experimental | Participants in this group will receive non-surgical peri-implantitis treatment using Er:YAG (2940 nm) and Diode (808 nm) lasers. The Er:YAG laser will be used for implant surface decontamination, while the Diode laser will be applied for biostimulation. Receives: Device: Er:YAG (2940nm) and Diode (808nm) Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Probing Pocket Depth (PPD)
Change in peri-implant probing pocket depth (PPD) from baseline to 3 months post-treatment. PPD is measured using a periodontal probe at six sites per implant.
Measured: Baseline and 3 months post-treatment
Secondary outcomes (11)
Bleeding on Probing (BOP)
Assessment of bleeding upon gentle probing at six sites per implant to evaluate inflammation.
Measured: Baseline and 3 months post-treatment
Clinical Attachment Level (CAL)
Measurement of the distance from the implant shoulder to the base of the peri-implant pocket.
Measured: Baseline and 3 months post-treatment
Peri-implant Mucosal Recession (REC)
Measurement of the vertical soft tissue recession at six implant sites.
Measured: Baseline and 3 months post-treatment
Presence of Suppuration (SUP)
Assessment of purulent exudate upon probing, indicating ongoing infection.
Measured: Baseline and 3 months post-treatment
Treatment Success (Yes/No)
Defined as pocket depth ≤5 mm with no bleeding on probing at more than one of six implant sites and no suppuration, per EFP S3 guidelines.
Measured: 3 months post-treatment
Change in P. gingivalis Levels
Quantification of Porphyromonas gingivalis using qPCR from subgingival plaque samples.
Measured: Baseline and 3 months post-treatment
Change in F. alocis Levels
Quantification of Filifactor alocis using qPCR from subgingival plaque samples.
Measured: Baseline and 3 months post-treatment
Metabolomic Profile Changes
Analysis of peri-implant crevicular fluid metabolites to assess biochemical changes post-treatment.
Measured: Baseline and 3 months post-treatment
Pain Evaluation (VAS Scale)
Pain assessment using a 100-mm Visual Analog Scale (VAS) at different time points (immediately post-treatment, 24, 48, and 72 hours). The VAS for Pain ranges from 0 to 100, where 0 represents no pain and 100 represents the worst possible pain. Higher scores indicate greater pain severity.
Measured: 0, 24, 48, and 72 hours post-treatment
Analgesic Consumption
Total number of analgesics taken by patients in the first week post-treatment.
Measured: Daily for 7 days post-treatment
Patient Satisfaction
Yes/No/Don't Know questionnaire assessing patient satisfaction with treatment outcomes.
Measured: 1 week post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start30 Jan 2025
- Primary completion5 Jun 2025
- Study completion5 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Peri-ImplantitisStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe 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
- Participants will be randomly assigned to one of two parallel groups: a control group receiving non-surgical ultrasonic debridement and an experimental group receiving Er:YAG and Diode laser treatment.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chariklia Neofytou, MSc, Principal investigator, Aristotle University Of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06890117
- Sponsor's protocol ID
- 26/29.01.2025
- Status last verified
- Jan 2026
- First submitted
- 17 Mar 2025
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The individual participant data (IPD) collected during this study, including clinical data (e.g., probing pocket depth, bleeding on probing), microbiological data (e.g., counts of P. gingivalis and F. alocis), and metabolomics data, will be made available to other researchers after the study's completion. This data will be shared for the purpose of further analysis, with a focus on advancing research in peri-implantitis and dental treatments.
Publications
Berglundh T, Armitage G, Araujo MG, Avila-Ortiz G, Blanco J, Camargo PM, Chen S, Cochran D, Derks J, Figuero E, Hammerle CHF, Heitz-Mayfield LJA, Huynh-Ba G, Iacono V, Koo KT, Lambert F, McCauley L, Quirynen M, Renvert S, Salvi GE, Schwarz F, Tarnow D, Tomasi C, Wang HL, Zitzmann N. Peri-implant diseases and conditions: Consensus report of workgroup 4 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Clin Periodontol. 2018 Jun;45 Suppl 20:S286-S291. doi: 10.1111/jcpe.12957.
PubMed 29926491Camps-Font O, Perez-Beltran I, Fornes-Nieto V, Gonzalez-Barnadas A, Costa-Berenguer X, Garcia-Garcia M, Figueiredo R, Valmaseda-Castellon E. Patient-centered outcomes after surgical treatment of peri-implantitis: a prospective clinical study. Med Oral Patol Oral Cir Bucal. 2023 Jan 1;28(1):e72-e80. doi: 10.4317/medoral.25587.
PubMed 36243998Grzech-Lesniak K, Sculean A, Gaspirc B. Laser reduction of specific microorganisms in the periodontal pocket using Er:YAG and Nd:YAG lasers: a randomized controlled clinical study. Lasers Med Sci. 2018 Sep;33(7):1461-1470. doi: 10.1007/s10103-018-2491-z. Epub 2018 May 15.
PubMed 29766330Mills MP, Rosen PS, Chambrone L, Greenwell H, Kao RT, Klokkevold PR, McAllister BS, Reynolds MA, Romanos GE, Wang HL. American Academy of Periodontology best evidence consensus statement on the efficacy of laser therapy used alone or as an adjunct to non-surgical and surgical treatment of periodontitis and peri-implant diseases. J Periodontol. 2018 Jul;89(7):737-742. doi: 10.1002/JPER.17-0356. No abstract available.
PubMed 29693260Schwarz F, Aoki A, Becker J, Sculean A. Laser application in non-surgical periodontal therapy: a systematic review. J Clin Periodontol. 2008 Sep;35(8 Suppl):29-44. doi: 10.1111/j.1600-051X.2008.01259.x.
PubMed 18724840Schwarz F, Sculean A, Georg T, Reich E. Periodontal treatment with an Er: YAG laser compared to scaling and root planing. A controlled clinical study. J Periodontol. 2001 Mar;72(3):361-7. doi: 10.1902/jop.2001.72.3.361.
PubMed 11327064Schwarz F, Sculean A, Rothamel D, Schwenzer K, Georg T, Becker J. Clinical evaluation of an Er:YAG laser for nonsurgical treatment of peri-implantitis: a pilot study. Clin Oral Implants Res. 2005 Feb;16(1):44-52. doi: 10.1111/j.1600-0501.2004.01051.x.
PubMed 15642030
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-surgical Treatment of Peri-implantitis Using Combined Er: YAG (2940nm) and Diode Laser (808nm): a Randomized Controlled Clinical Trial. Clinical, Microbiological Parameters and Metabolomics
- ClinicalTrials.gov ID
- NCT06890117
- Acronym / sponsor ID
- 26/29.01.2025
- Conditions
- Peri-Implantitis
- Keywords
- Non-surgical therapy, Er:YAG laser, Diode laser, Microbiological analysis, Metabolomics, RCT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- 30 Jan 2025 (actual)
- Primary completion
- 5 Jun 2025 (actual)
- Study completion
- 5 Jun 2025 (actual)
- First posted
- 21 Mar 2025 (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.
A prospective, randomized clinical trial with a 3-month duration was designed to evaluate the efficacy of non-surgical treatment for peri-implantitis. Patients presenting at the Postgraduate Periodontology Clinic of the School of Dentistry, Aristotle University of Thessaloniki, with a diagnosis of peri-implantitis in at least one implant (based on the new classification of periodontal and peri-implant diseases, EFP 2018) will be included.
After clinical and radiographic evaluation, patients will be randomly assigned to two groups, with each patient participating in the study with one implant. The control group will receive non-surgical treatment using ultrasonic scalers designed for implants, combined with saline irrigation. The experimental group will undergo non-surgical treatment with Er:YAG (2940nm) and Diode (808nm) laser. All patients will receive oral hygiene instructions at baseline and during each subsequent visit.
Microbial plaque samples will be collected using two sterile paper cones from the deepest peri-implant pocket before treatment and three months after treatment. The presence and absolute counts of Porphyromonas gingivalis and Filifactor alocis will be assessed using quantitative polymerase chain reaction (qPCR). Additionally, peri-implant crevicular fluid will be collected from the second deepest peri-implant pocket using three sterile paper cones before treatment and three months post-treatment for metabolomic analysis.
Clinical parameters, including probing pocket depth (PPD), bleeding on probing (BOP), clinical attachment level (CAL), peri-implant mucosal recession (REC), and suppuration (SUP), will be recorded at baseline and at the end of the experimental period (3 months). Treatment success will be evaluated at the 3-month mark, defined as a pocket depth ≤5 mm with no bleeding on probing at more than one of six implant sites and no suppuration, according to the EFP S3 level clinical practice guideline.
Additionally, patients will complete a home questionnaire to assess pain at different time points (immediately after treatment, 24, 48, and 72 hours post-treatment). Pain levels will be evaluated using a 100-mm visual analog scale (VAS), where 0 mm indicates "no pain" and 100 mm represents "worst pain." The total number of analgesics consumed daily for one week post-treatment will also be recorded. At the end of the week, patients will answer four Yes/No/Don't Know questions to assess their satisfaction with the treatment.
Detailed description
This study aims to compare the effectiveness of non-surgical peri-implantitis treatment using conventional ultrasonic debridement versus a laser-assisted approach. The primary objective is to assess clinical, microbiological, and metabolomic outcomes associated with each treatment modality.
The study will be conducted at the Postgraduate Periodontology Clinic of the School of Dentistry, Aristotle University of Thessaloniki. Participants will be screened based on inclusion and exclusion criteria, and those diagnosed with peri-implantitis in at least one implant will be randomly assigned to either the control or experimental group.
Study Procedures:
Control Group: Treatment with ultrasonic scalers designed for implants and saline irrigation.
Experimental Group: Treatment with Er:YAG (2940nm) and Diode (808nm) laser.
Oral Hygiene Instructions: Provided at baseline and each follow-up visit.
Microbiological Sampling: Collection of subgingival plaque using sterile paper cones before and after treatment (3 months), with analysis of P. gingivalis and F. alocis using qPCR.
Metabolomic Analysis: Collection of peri-implant crevicular fluid before and after treatment for metabolomic profiling.
Clinical Parameters: PPD, BOP, CAL, REC, and SUP will be recorded at baseline and after 3 months.
Pain and Patient Satisfaction: VAS pain assessment at multiple time points and tracking of analgesic consumption. A patient satisfaction questionnaire will be completed at the end of the study.
Study Outcomes:
Primary Outcome: Reduction in peri-implant pocket depth and inflammation.
Secondary Outcomes: Changes in microbiological and metabolomic markers, pain perception, and patient-reported satisfaction.
This randomized controlled clinical trial aims to provide valuable insights into the efficacy of laser-assisted non-surgical therapy for peri-implantitis compared to conventional ultrasonic debridement. The findings could contribute to the optimization of non-surgical treatment protocols for peri-implant disease management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two parallel groups: a control group receiving non-surgical ultrasonic debridement and an experimental group receiving Er:YAG and Diode laser treatment.
| Arm | Type | Receives |
|---|---|---|
| Ultrasonic Debridement + Saline Irrigation | Active comparator | Device: Ultrasonic Scalers with EMS PI tip and Saline IrrigationParticipants in this group will receive non-surgical mechanical debridement using ultrasonic scalers specifically designed for implant surfaces, followed by irrigation with saline solution. No additional laser therapy will be applied. |
| Er:YAG + Diode Laser | Experimental | Device: Er:YAG (2940nm) and Diode (808nm) LaserParticipants in this group will receive non-surgical peri-implantitis treatment using Er:YAG (2940 nm) and Diode (808 nm) lasers. The Er:YAG laser will be used for implant surface decontamination, while the Diode laser will be applied for biostimulation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients presenting at the Postgraduate Periodontology Clinic with a diagnosis of peri-implantitis in at least one implant, based on the 2018 Classification of Periodontal and Peri-Implant Diseases (EFP 2018).
- Probing pocket depth (PPD) of up to 10 mm.
- Periodontally healthy individuals (no active periodontal disease).
- Implants must have been in function (loaded) for at least one year.
- Age ≥ 18 years.
Key exclusion criteria (5 listed)
- Presence of systemic diseases or medications that could influence treatment outcomes (e.g., uncontrolled diabetes, chemotherapy, immunosuppression).
- Underwent peri-implantitis treatment in the past 3 months.
- Use of antibiotics or antimicrobial therapy in the past 3 months.
- Pregnancy or breastfeeding.
- Smokers
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 |
|---|---|---|
| Ultrasonic Scalers with EMS PI tip and Saline IrrigationAlso: Ultrasonic DebridementControl Group: Non-surgical peri-implantitis treatment using ultrasonic scalers and EMS PI tips designed for implants, combined with saline irrigation to remove plaque and biofilm from implant surfaces. | Device | Ultrasonic Debridement + Saline Irrigation |
| Er:YAG (2940nm) and Diode (808nm) LaserAlso: Laser-Assisted Peri-Implantitis TreatmentExperimental Group: Non-surgical peri-implantitis treatment using Er:YAG laser (2940nm) and Diode laser (808nm) for decontamination of the implant surface and surrounding tissues. The Er:YAG laser is used for mechanical debridement and biofilm removal, while the Diode laser has biostimulatory effects. | Device | Er:YAG + Diode Laser |
Primary outcome
Change in Probing Pocket Depth (PPD)
Time frame: Baseline and 3 months post-treatment
Change in peri-implant probing pocket depth (PPD) from baseline to 3 months post-treatment. PPD is measured using a periodontal probe at six sites per implant.
11 secondary outcomes
Bleeding on Probing (BOP)
Time frame: Baseline and 3 months post-treatment
Clinical Attachment Level (CAL)
Time frame: Baseline and 3 months post-treatment
Peri-implant Mucosal Recession (REC)
Time frame: Baseline and 3 months post-treatment
Presence of Suppuration (SUP)
Time frame: Baseline and 3 months post-treatment
Treatment Success (Yes/No)
Time frame: 3 months post-treatment
Change in P. gingivalis Levels
Time frame: Baseline and 3 months post-treatment
Change in F. alocis Levels
Time frame: Baseline and 3 months post-treatment
Metabolomic Profile Changes
Time frame: Baseline and 3 months post-treatment
Pain Evaluation (VAS Scale)
Time frame: 0, 24, 48, and 72 hours post-treatment
Analgesic Consumption
Time frame: Daily for 7 days post-treatment
Patient Satisfaction
Time frame: 1 week post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Background: PubMed 29926491Berglundh T, Armitage G, Araujo MG, Avila-Ortiz G, Blanco J, Camargo PM, Chen S, Cochran D, Derks J, Figuero E, Hammerle CHF, Heitz-Mayfield LJA, Huynh-Ba G, Iacono V, Koo KT, Lambert F, McCauley L, Quirynen M, Renvert S, Salvi GE, Schwarz F, Tarnow D, Tomasi C, Wang HL, Zitzmann N. Peri-implant diseases and conditions: Consensus report of workgroup 4 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Clin Periodontol. 2018 Jun;45 Suppl 20:S286-S291. doi: 10.1111/jcpe.12957.
- Background: PubMed 36243998Camps-Font O, Perez-Beltran I, Fornes-Nieto V, Gonzalez-Barnadas A, Costa-Berenguer X, Garcia-Garcia M, Figueiredo R, Valmaseda-Castellon E. Patient-centered outcomes after surgical treatment of peri-implantitis: a prospective clinical study. Med Oral Patol Oral Cir Bucal. 2023 Jan 1;28(1):e72-e80. doi: 10.4317/medoral.25587.
- Background: PubMed 29766330Grzech-Lesniak K, Sculean A, Gaspirc B. Laser reduction of specific microorganisms in the periodontal pocket using Er:YAG and Nd:YAG lasers: a randomized controlled clinical study. Lasers Med Sci. 2018 Sep;33(7):1461-1470. doi: 10.1007/s10103-018-2491-z. Epub 2018 May 15.
- Background: PubMed 29693260Mills MP, Rosen PS, Chambrone L, Greenwell H, Kao RT, Klokkevold PR, McAllister BS, Reynolds MA, Romanos GE, Wang HL. American Academy of Periodontology best evidence consensus statement on the efficacy of laser therapy used alone or as an adjunct to non-surgical and surgical treatment of periodontitis and peri-implant diseases. J Periodontol. 2018 Jul;89(7):737-742. doi: 10.1002/JPER.17-0356. No abstract available.
- Background: PubMed 18724840Schwarz F, Aoki A, Becker J, Sculean A. Laser application in non-surgical periodontal therapy: a systematic review. J Clin Periodontol. 2008 Sep;35(8 Suppl):29-44. doi: 10.1111/j.1600-051X.2008.01259.x.
- Background: PubMed 11327064Schwarz F, Sculean A, Georg T, Reich E. Periodontal treatment with an Er: YAG laser compared to scaling and root planing. A controlled clinical study. J Periodontol. 2001 Mar;72(3):361-7. doi: 10.1902/jop.2001.72.3.361.
- Background: PubMed 15642030Schwarz F, Sculean A, Rothamel D, Schwenzer K, Georg T, Becker J. Clinical evaluation of an Er:YAG laser for nonsurgical treatment of peri-implantitis: a pilot study. Clin Oral Implants Res. 2005 Feb;16(1):44-52. doi: 10.1111/j.1600-0501.2004.01051.x.
- Individual participant dataSharing planned: Yes. The individual participant data (IPD) collected during this study, including clinical data (e.g., probing pocket depth, bleeding on probing), microbiological data (e.g., counts of P. gingivalis and F. alocis), and metabolomics data, will be made available to other researchers after the study's completion. This data will be shared for the purpose of further analysis, with a focus on advancing research in peri-implantitis and dental treatments.
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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. This study is not recruiting at the moment.
Chariklia Neofytou, MSc principal investigator
Aristotle University Of Thessaloniki
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasonic Scalers with EMS PI tip and Saline Irrigation and Er:YAG (2940nm) and Diode (808nm) Laser in people with Peri-Implantitis, run by Aristotle University Of Thessaloniki at 1 site in Greece.
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 9 inclusion and 5 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: finished, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Probing Pocket Depth (PPD) (time frame: Baseline and 3 months post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06890117, which also lists 7 linked publications.
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 27 Jan 2026.