Effect of 940 nm Diode Laser as an Adjunct to Mechanical Debridement on S100A8 Levels and Clinical Parameters in Peri-Implantitis Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Change in S100A8 levels in Peri-Implant Sulcular Fluid (PISF)
研究概览
简要总结
Purpose: The aim of this study was to compare the effectiveness of diode laser and combined treatment protocols, applied in addition to mechanical debridement, in the treatment of peri-implantitis on clinical periodontal parameters and S100A8 levels in peri-implant sulcus fluid (PISF).
Methods: A total of 39 patients diagnosed with peri-implantitis were divided into three groups based on the treatment protocols used: Mechanical Debridement, Diode Laser, and Combined Treatment. Probing depth, clinical attachment level, modified plaque index, gingival index, and PISF volume measurements were recorded at baseline and at weeks 4 and 12. S100A8 levels in PISF samples were measured by ELISA.
详细描述
This study included 39 functional implants in patients aged 30-65 diagnosed with peri-implantitis (PD ≥6 mm, no clinical mobility). Participants were assigned to three groups (n=13 per group) using simple randomization (coin toss) performed by an independent researcher: Group 1 (Mechanical debridement only), Group 2 (940 nm diode laser monotherapy), and Group 3 (Combined mechanical debridement and diode laser). Exclusion criteria consisted of systemic diseases, smoking or alcohol consumption, pregnancy/lactation, parafunctional habits, and recent use of antibiotics (within 6 months) or peri-implant treatment (within 3 months). At baseline, clinical parameters were recorded and peri-implant sulcular fluid (PISF) samples were collected. Specifically, probing depth (PD) and clinical attachment level (CAL) were measured at 6 sites per implant, while the modified plaque index (mPI) and gingival index (GI) were assessed at 4 sites per implant.
Prior to PISF sampling, supragingival plaque was removed using sterile curettes, and the area was isolated and air-dried. Samples were collected from mesial and distal sites using paper strips (Ora Flow) inserted 1 mm into the sulcus for 30 seconds; contaminated strips were discarded. PISF volume was measured in microliters using a Periotron 8000 device, and samples were stored at -80°C until analysis. Treatment protocols included: mechanical debridement with titanium curettes for Group 1; decontamination using a 940 nm diode laser (2.5 W, CP2 mode, 400 μm fiber tip) for 30 seconds for Group 2; and a sequential combination of both treatments for Group 3. Following treatment, all pockets were irrigated with 10% povidone-iodine. Clinical parameters and PISF samples were evaluated at baseline (T0), week 4 (T1), and week 12 (T2). For biochemical analysis, S100A8 levels were determined via ELISA at 450 nm and calculated as ng/mL using a standard curve.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 30 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals aged 30-65 years.
- •Presence of at least one functional dental implant with no clinical mobility
- •Diagnosis of peri-implantitis with a probing depth (PD) of ≥ 6 mm.
- •Ability to provide informed consent and attend follow-up visits.
排除标准
- •Systemic diseases that may interfere with wound healing (e.g., uncontrolled diabetes).
- •History of radiation or chemotherapy.
- •Pregnancy or lactation.
- •Smoking or alcohol consumption.
- •Parafunctional habits (e.g., bruxism).
- •Use of systemic antibiotics within the last 6 months.
- •Periodontal or peri-implant treatment in the relevant area within the last 3 months.
研究组 & 干预措施
Diode Laser Monotherapy Group
13 participants. Procedure: Decontamination using a 940 nm diode laser (2.5 W, CP2 mode) to remove biofilm from the implant surfaces. Collection of PISF samples.
Combined Group
13 participants. Procedure: Sequential application of subgingival mechanical debridement followed by 940 nm diode laser decontamination. Collection of PISF samples.
Mechanical Debridement Group
13 participants. Procedure: Subgingival mechanical debridement using sterile titanium curettes to remove biofilm and deposits from the implant surfaces. Collection of PISF samples.
结局指标
主要结局
Change in S100A8 levels in Peri-Implant Sulcular Fluid (PISF)
时间窗: Baseline (Day 0), 28 days (Week 4), and 84 days (Week 12)
S100A8 levels will be measured using an ELISA kit (ng/mL) to evaluate the inflammatory response.
次要结局
- Probing Depth (PD)(Baseline (Day 0), 28 days (Week 4), and 84 days (Week 12))
- Clinical Attachment Level (CAL)(Baseline (Day 0), 28 days (Week 4), and 84 days (Week 12))
- Modified Plaque Index (mPI)(Baseline (Day 0), 28 days (Week 4), and 84 days (Week 12))
- Gingival Index (GI)(Baseline (Day 0), 28 days (Week 4), and 84 days (Week 12))
研究者
Akif Nalbant
DDS
Kırıkkale University
