Comparative evaluation of the effect of Photodynamic therapy and Photoablation as an adjunct to Open Flap Debridement in periodontitis patients– A Double Blinded Randomized Controlled Trial.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- To compare the effectiveness of open flap debridement (OFD), open flap debridement with photodynamic therapy (PDT), and open flap debridement with photoablation (PA) in managing periodontitis patients by evaluating the reduction in probing pocket depth (PPD) and gain in clinical attachment level (CAL) at baseline, 3 months and 6 months post-surgery.
研究概览
简要总结
The comparative effect of lasers in surgical periodontal treatment using photodynamic therapy and photoablasion is unclear with insufficient data.The purpose of this study is to compare and evaluate the adjunctive benefits of a diode laser to conventional surgical debridement in the treatment of periodontitis, testing the hypothesis that adjunctive use of photodynamic or photoablation therapy to open flap debridement can improve outcomes of surgical periodontal therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants aged between 18 to 55 years.
- •Patients requiring flap surgery for at least a quadrant (5 ≤ PPD ≤ 7) after phase I therapy.
- •ASA I and II 4) Patients willing to comply with the study protocol and follow-up visits.
- •Patients with signed informed consent forms.
排除标准
- •Individuals with poor oral hygiene {Plaque Index (PI) ≥1} on day of follow up after phase I therapy.
- •Patient’s teeth with more than grade II mobility and grade III and IV furcation involvement.
- •Patients with a history of antibiotic therapy within the last 3 months.
- •Patients with previous surgical periodontal treatment within the last 6 months.
- •Patients who smoke or use any form of tobacco products.
- •Patients who are Pregnant or lactating.
- •Patients with a history of allergy or sensitivity to Methylene blue dye.
结局指标
主要结局
To compare the effectiveness of open flap debridement (OFD), open flap debridement with photodynamic therapy (PDT), and open flap debridement with photoablation (PA) in managing periodontitis patients by evaluating the reduction in probing pocket depth (PPD) and gain in clinical attachment level (CAL) at baseline, 3 months and 6 months post-surgery.
时间窗: Baseline, 3 months and 6 months post-surgery.
次要结局
- To compare the effectiveness of open flap debridement (OFD), open flap debridement with photodynamic therapy (PDT), and open flap debridement with photoablation (PA) in managing periodontitis patients by evaluating the reduction in bleeding on probing (BOP) and plaque index (PI), gingival index (GI) at baseline, 3 months and 6 months post-surgery.(baseline, 3 months and 6 months post-surgery.)
研究者
Dr. Raghavendra Metri
Maharashtra Institute of Dental Sciences and Research dental college Latur.