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

NCT06890117 | Completed

• 1 other identifier: 26/29.01.2025
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Peri-Implantitis

Keywords

Non-surgical therapy; Er:YAG laser; Diode laser; Microbiological analysis; Metabolomics; RCT

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 3 months post-treatment

Secondary Outcomes (11)

• Bleeding on Probing (BOP)

  Baseline and 3 months post-treatment

• Clinical Attachment Level (CAL)

  Baseline and 3 months post-treatment

• Peri-implant Mucosal Recession (REC)

  Baseline and 3 months post-treatment

• Presence of Suppuration (SUP)

  Baseline and 3 months post-treatment

• Treatment Success (Yes/No)

  3 months post-treatment

Study Arms (2)

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.

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.

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

Interventions

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.

Also known as: Ultrasonic Debridement

Ultrasonic Debridement + Saline Irrigation

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.

Also known as: Laser-Assisted Peri-Implantitis Treatment

Er:YAG + Diode Laser

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead

Study Sites (1)

Aristotle University of Thessaloniki

Thessaloniki, 54124, Greece

Location

Related Publications (7)

• 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.

  PMID: 29926491 BACKGROUND

• Camps-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.

  PMID: 36243998 BACKGROUND

• Grzech-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.

  PMID: 29766330 BACKGROUND

• Mills 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.

  PMID: 29693260 BACKGROUND

• Schwarz 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.

  PMID: 18724840 BACKGROUND

• Schwarz 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.

  PMID: 11327064 BACKGROUND

• Schwarz 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.

  PMID: 15642030 BACKGROUND

MeSH Terms

Conditions

Peri-Implantitis

Interventions

Lasers

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Chariklia Neofytou, MSc

  Aristotle University Of Thessaloniki

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor evaluating clinical and microbiological parameters will be blinded to the treatment allocation to minimize bias.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 17, 2025
• First Posted: March 21, 2025
• Study Start: January 30, 2025
• Primary Completion: June 5, 2025
• Study Completion: June 5, 2025
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• 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.
• 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.

Locations

GR (1)