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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Change in Probing Pocket Depth (PPD)
Study Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
The outcomes assessor evaluating clinical and microbiological parameters will be blinded to the treatment allocation to minimize bias.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: Ultrasonic Scalers with EMS PI tip and Saline Irrigation (Device)
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.
Intervention: Er:YAG (2940nm) and Diode (808nm) Laser (Device)
Outcomes
Primary Outcomes
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
- Analgesic Consumption(Daily for 7 days post-treatment)
- Bleeding on Probing (BOP)(Baseline and 3 months post-treatment)
- Pain Evaluation (VAS Scale)(0, 24, 48, and 72 hours 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)
- Change in P. gingivalis Levels(Baseline and 3 months post-treatment)
- Change in F. alocis Levels(Baseline and 3 months post-treatment)
- Metabolomic Profile Changes(Baseline and 3 months post-treatment)
- Patient Satisfaction(1 week post-treatment)