Skip to main content
OpenTrials
Completed

NCT Number: NCT06890117

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Peri-implantitis Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aristotle University of Thessaloniki

Thessaloniki, 54124, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasonic Scalers with EMS PI tip and Saline Irrigation

Device

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

Er:YAG (2940nm) and Diode (808nm) Laser

Device

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. Peri-implant Mucosal Recession (REC)

    Time frame: Baseline and 3 months post-treatment

    Measurement of the vertical soft tissue recession at six implant sites.

  4. Presence of Suppuration (SUP)

    Time frame: Baseline and 3 months post-treatment

    Assessment of purulent exudate upon probing, indicating ongoing infection.

  5. 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.

  6. Change in P. gingivalis Levels

    Time frame: Baseline and 3 months post-treatment

    Quantification of Porphyromonas gingivalis using qPCR from subgingival plaque samples.

  7. Change in F. alocis Levels

    Time frame: Baseline and 3 months post-treatment

    Quantification of Filifactor alocis using qPCR from subgingival plaque samples.

  8. Metabolomic Profile Changes

    Time frame: Baseline and 3 months post-treatment

    Analysis of peri-implant crevicular fluid metabolites to assess biochemical changes post-treatment.

  9. 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.

  10. Analgesic Consumption

    Time frame: Daily for 7 days post-treatment

    Total number of analgesics taken by patients in the first week post-treatment.

  11. Patient Satisfaction

    Time frame: 1 week post-treatment

    Yes/No/Don't Know questionnaire assessing patient satisfaction with treatment outcomes.

Sponsors and collaborators

Lead sponsor

Aristotle University Of Thessaloniki

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 21, 2025
Registry last updated
Jan 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.