跳至主要内容
临床试验/NCT07524153
NCT07524153已完成不适用

Effect of 940 nm Diode Laser as an Adjunct to Mechanical Debridement on S100A8 Levels and Clinical Parameters in Peri-Implantitis Treatment

Kırıkkale University1 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2025年1月1日最近更新:
适应症

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

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

发起方
Kırıkkale University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Akif Nalbant

DDS

Kırıkkale University

研究点 (1)

Loading locations...

相似试验