Non-Surgical Laser Treatment for Peri-Implantitis: Er:YAG & Diode Laser

January 24, 2026 updated by: Aristotle University Of Thessaloniki

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / 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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Thessaloniki, Greece, 54124
        • Aristotle University of Thessaloniki

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.
  • Implant-supported restorations must be accessible for proper oral hygiene.
  • Patients must provide signed informed consent for participation.
  • Non-smokers only

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ultrasonic Debridement + Saline Irrigation
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.
Device: Ultrasonic Scalers with EMS PI tip and Saline Irrigation
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.
Other Names:
  • Ultrasonic Debridement
Experimental: Er:YAG + Diode Laser
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.
Device: Er:YAG (2940nm) and Diode (808nm) Laser
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.
Other Names:
  • Laser-Assisted Peri-Implantitis Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 3 months post-treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Attachment Level (CAL)
Time Frame: Baseline and 3 months post-treatment
Measurement of the distance from the implant shoulder to the base of the peri-implant pocket.
Baseline and 3 months post-treatment
Peri-implant Mucosal Recession (REC)
Time Frame: Baseline and 3 months post-treatment
Measurement of the vertical soft tissue recession at six implant sites.
Baseline and 3 months post-treatment
Presence of Suppuration (SUP)
Time Frame: Baseline and 3 months post-treatment
Assessment of purulent exudate upon probing, indicating ongoing infection.
Baseline and 3 months post-treatment
Treatment Success (Yes/No)
Time Frame: 3 months post-treatment
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.
3 months post-treatment
Change in P. gingivalis Levels
Time Frame: Baseline and 3 months post-treatment
Quantification of Porphyromonas gingivalis using qPCR from subgingival plaque samples.
Baseline and 3 months post-treatment
Change in F. alocis Levels
Time Frame: Baseline and 3 months post-treatment
Quantification of Filifactor alocis using qPCR from subgingival plaque samples.
Baseline and 3 months post-treatment
Metabolomic Profile Changes
Time Frame: Baseline and 3 months post-treatment
Analysis of peri-implant crevicular fluid metabolites to assess biochemical changes post-treatment.
Baseline and 3 months post-treatment
Analgesic Consumption
Time Frame: Daily for 7 days post-treatment
Total number of analgesics taken by patients in the first week post-treatment.
Daily for 7 days post-treatment
Patient Satisfaction
Time Frame: 1 week post-treatment
Yes/No/Don't Know questionnaire assessing patient satisfaction with treatment outcomes.
1 week post-treatment
Bleeding on Probing (BOP)
Time Frame: Baseline and 3 months post-treatment
Assessment of bleeding upon gentle probing at six sites per implant to evaluate inflammation.
Baseline and 3 months post-treatment
Pain Evaluation (VAS Scale)
Time Frame: 0, 24, 48, and 72 hours post-treatment
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.
0, 24, 48, and 72 hours post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aristotle University Of Thessaloniki

Investigators

  • Principal Investigator: Chariklia Neofytou, MSc, Aristotle University of Thessaloniki

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 30, 2025

Primary Completion (Actual)

June 5, 2025

Study Completion (Actual)

June 5, 2025

Study Registration Dates

First Submitted

March 17, 2025

First Submitted That Met QC Criteria

March 20, 2025

First Posted (Actual)

March 21, 2025

Study Record Updates

Last Update Posted (Actual)

January 27, 2026

Last Update Submitted That Met QC Criteria

January 24, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 26/29.01.2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

The individual participant data, along with the supporting information, will become available after the publication of the final results of this study. The exact timeline for availability and duration of access has not yet been decided.

IPD Sharing Access Criteria

The access criteria for the individual participant data (IPD) and supporting information have not yet been decided. Further details regarding the review process, who will have access, and the types of analyses permitted will be determined after the publication of the final study results.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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