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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in Probing Pocket Depth (PPD)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The outcomes assessor evaluating clinical and microbiological parameters will be blinded to the treatment allocation to minimize bias.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: 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.
干预措施: Er:YAG (2940nm) and Diode (808nm) Laser (Device)
结局指标
主要结局
Change in Probing Pocket Depth (PPD)
时间窗: 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.
次要结局
- 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)