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

Not Applicable

Recruiting

• Conditions: Peri-Implantitis

• Registration Number: NCT06890117
• Lead Sponsor: Aristotle University Of Thessaloniki

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.

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 Timeline

• Study Start: 2024-04-02
• Status Verified: 2025-03
• Study First Submitted: 2025-03-17
• Study First Submitted QC: 2025-03-20
• Last Update Submitted: 2025-03-20
• Study First Posted: 2025-03-21
• Last Update Posted: 2025-03-21
• Primary Completion: 2025-05
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 36

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). Only implants with a probing pocket depth (PPD) of up to 10 mm will be included.

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 in the study. 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 last 3 months. Pregnancy or breastfeeding. Smokers

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Probing Pocket Depth (PPD)	Baseline and 3 months post-treatment	Reduction 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 Outcome Measures

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

Trial Locations

Locations (1)

Aristotle University of Thessaloniki; 🇬🇷 Thessaloniki, Greece