Comparative Evaluation of Autologous PRF, 1% Alendronate and 1.2% Atorvastatin Gel in Treatment of 2/3-walled Intrabony Defects in Chronic Periodontitis Subjects: a Randomized Controlled Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 主要终点
- defect depth reduction (DDR)
研究概览
简要总结
The present study is designed as a single-centre, randomized, controlled clinical trial to evaluate and compare the clinical efficacy of autologous PRF, 1% alendronate (ALN) and 1.2% atorvastatin (ATV) gel placement with open flap debriedement in treatment of intrabony defects in patients with chronic periodontitis.
详细描述
Background: Platelet-rich fibrin (PRF) is a second-generation platelet concentrate which releases various growth factors that promote tissue regeneration. Alendronate and Atorvastatin are known to inhibit osteoclastic bone resorption and were proposed to have osteostimulative properties by causing osteoblast differentiation in vivo and in vitro as shown by an increase in matrix formation. The aim of the present study is to evaluate and compare the efficacy of autologous PRF, 1% alendronate and 1.2% atorvastatin gel placement with open flap debriedement in treatment of intrabony defects in patients with chronic periodontitis.
Methods: 120 CP subjects with IBD ≥3 mm deep and probing depth (PD) ≥5 mm, following scaling and root planing (SRP), were categorized into four treatment groups: 1) OFD 2) OFD with PRF 3) OFD with 1% ALN gel and 4) OFD with 1.2% ATV gel. Clinical parameters including site specific plaque index (PI), modified sulcus bleeding index (mSBI), probing depth (PD) and relative attachment level (RAL) as well as percentage radiographic intrabony defect depth reduction (DDR) were recorded at baseline before surgery and 9 months post-operatively.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Systemically healthy patients with PDs ≥5mm or CALs ≥4 to 6mm and vertical bone loss ≥3 mm on intraoral periapical radiographs with no history of periodontal therapy or use of antibiotics in the preceding 6 months were included
排除标准
- •Patients with a known systemic disease
- •Known or suspected allergy to the ALN/ bisphosphonates or ATV/statin group
- •On systemic ALN/ bisphosphonates or ATV/statin group
- •With aggressive periodontitis
- •Who used tobacco in any form
- •Alcoholics
- •Immunocompromised patients
- •And pregnant or lactating females were excluded from the study
研究组 & 干预措施
PRF group
SRP with Open flap debridement (OFD) with autologous Platelet rich fibrin (PRF) placement into intrabony defect
干预措施: OFD with PRF (Biological)
Open flap debridement group
SRP with Open flap debridement (OFD) alone for treating intrabony defect
干预措施: Open flap debridement (OFD) (Procedure)
Alendronate group
SRP with Open flap debridement (OFD) with 1% Alendronate (ALN) placement into intrabony defect
干预措施: OFD with ALN (Drug)
Atorvastatin group
SRP with Open flap debridement (OFD) with 1.2% Atorvastatin (ATV) placement into intrabony defect
干预措施: OFD with ATV (Drug)
结局指标
主要结局
defect depth reduction (DDR)
时间窗: Change from baseline to 9 months
次要结局
- change in clinical attachment level (CAL)(Change from baseline to 9 months)
- change in probing pocket depths (PPD)(Change from baseline to 9 months)
- change in plaque index (PI)(Change from baseline to 9 months)
研究者
Dr. A R Pradeep
Professor and Head
Government Dental College and Research Institute, Bangalore