Efficacy of Diode Laser and Non-Surgical Periodontal Therapy in the Treatment of Periodontitis: A Clinical and Immunological Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Change in clinical periodontal parameters (Plaque Index)
研究概览
简要总结
The aim of this study is to evaluate the efficacy of diode laser in addition to periodontal treatment in periodontitis patients and to investigate their effects on gingival crevicular fluid (GCF) cytokine levels before and after treatment, among some Yemeni individuals in Sana'a city.
详细描述
This study aims to compare the clinical and immunological effects of traditional mechanical debridement alone versus combined treatment with diode laser (high and low power). The clinical parameters include Plaque Index (PI), Gingival Index (GI), Periodontal Pocket Depth (PPD), and Clinical Attachment Loss (CAL). Immunological parameters include IL-1β, IL-6, IL-8, and TNF-α levels in GCF. Participants will be selected from the Yemeni population residing in Sana'a City. The study will include a control group receiving conventional therapy and two test groups receiving diode laser therapy with high and low intensity settings, respectively. Measurements will be recorded at baseline (T0), one month after treatment (T1), and three months post-treatment (T2).
The goal is to determine whether adjunctive diode laser therapy provides additional clinical and immunological benefits compared to conventional treatment alone.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 58 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients diagnosed with generalized periodontitis (presence of bleeding on probing [BOP] and probing pocket depth [PPD] ≥ 4 mm)
- •Age between 25 and 58 years
- •Presence of at least 20 natural teeth present.
排除标准
- •Smokers or qat chewers
- •Pregnant or lactating women
- •Patients taking medications that may influence periodontal tissue status
- •Patients with systemic conditions affecting periodontal health
- •Patients who received periodontal therapy or antibiotic treatment within the last 3 months
- •Patients wearing intraoral appliances or having dental prostheses
研究组 & 干预措施
Low Diode Laser (L D Laser)
Low power laser(0. 5W) is applicated to patient after curettage
干预措施: Curettage (SRT) only (Procedure)
scaling and root planning (SRP)
Patients receive only subgingival curettage by curettes and ultrasonic scaler
干预措施: Curettage (SRT) only (Procedure)
High Diode Laser (H D Laser)
Patients recieved high power diode laser (2W) after curettage to pocket disinfection and tissue healing
干预措施: High power diode laser + SRT (Procedure)
High Diode Laser (H D Laser)
Patients recieved high power diode laser (2W) after curettage to pocket disinfection and tissue healing
干预措施: Curettage (SRT) only (Procedure)
Low Diode Laser (L D Laser)
Low power laser(0. 5W) is applicated to patient after curettage
干预措施: Low diode diode laser + SRT (Procedure)
结局指标
主要结局
Change in clinical periodontal parameters (Plaque Index)
时间窗: Baseline,1 month, 3months after treatment
Clinical evaluation of plaque index will be performed at three points before treatment (T0), 1 month (T1) anD 3 months (T2) after treatment to evaluate periodontal improvement
Change in clinical periodontal parameters (Gingival Index)
时间窗: Baseline,1 month, 3months after treatment
Clinical evaluation of gingival index will be performed at three points before treatment (T0), 1 month (T1) anD 3 months (T2) after treatment to evaluate periodontal improvement
Change in clinical periodontal parameters (Periodontal Pocket Depth)
时间窗: Baseline,1 month, 3months after treatment
Clinical evaluation of periodontal pocket depth will be performed at three points before treatment (T0), 1 month (T1) anD 3 months (T2) after treatment to evaluate periodontal improvement
Change in clinical periodontal parameters (Clinical attachment level)
时间窗: Baseline,1 month, 3months after treatment
Clinical evaluation of clinical attachment level will be performed at three points before treatment (T0), 1 month (T1) anD 3 months (T2) after treatment to evaluate periodontal improvement
次要结局
- Change in interleukin-1B (IL-1B) levels in GCF(Baseline,1 month, 3months after treatment)
- Change in interleukin-6 (IL-6) levels in GCF(Baseline,1 month, 3months after treatment)
- Change in interleukin-8 (IL-8) levels in GCF(Baseline,1 month, 3months after treatment)
- Change in tumor necrosis factor-alpha (TNF-α) levels in GCF(Baseline,1 month, 3months after treatment)
研究者
Amani Abdulhakeem Alsharani
Assistant Lecturer and principal investigator
University of Science and Technology, Yemen