Regenerative Potential of Advanced Platelet Rich Fibrin (A-PRF) and Bioactive Glass (Perioglas®) Bone Graft in the Treatment of Intrabony Defects; A Comparative Clinico Radiographic Study.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- probing depth
研究概览
简要总结
The aim of this study is to evaluate and compare the regenerative potential of Advanced Platelet Rich Fibrin (A-PRF) and Bioactive Glass (Perioglas®) bone graft in the treatment of intrabony defects in chronic periodontitis patients.
详细描述
45 sites with vertical intrabony alveolar defects will be selected. These defect sites will be allocated randomly into 3 groups as Group I, Group II and Group III.
- Group I will be treated with open flap debridement and filled with A-PRF
- Group II will be treated with open flap debridement and filled with Bioactive glass (Perioglas®)
- Group III will be treated with open flap debridement and filled Bioactive glass (Perioglas®) and A-PRF.
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)
盲法说明
patient and statistician will be masked about the treatment regimen
入排标准
- 年龄范围
- 25 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: 25 to 55 years.
- •Gender: Both males and females will be included in the study.
- •Co-operative and motivated patients committed to oral hygiene.
- •Patients exhibiting intrabony defects.
排除标准
- •Patients with contraindication to periodontal surgery & local anesthesia.
- •Any systemic disease affecting the bone density and outcome of periodontal therapy.
- •Smokers, alcoholics, and patients with other adverse habits.
- •Pregnant, nursing and menopausal women.
- •Any known allergy/ hypersensitivity to any product used in this study.
- •Patients on long-term systemic therapy (antibiotics, anti-inflammatory bisphosphonates, hormonal replacement therapy and any other), taking any drug known to have periodontal implications that may interfere with wound healing.
- •Patients taking any anti-platelet and anticoagulant medication.
- •Patients who have undergone periodontal treatment within a period of past 1 year.
研究组 & 干预措施
open flap debridement and filled with A-PRF
After phase 1 therapy, surgical procedure would be carried out in the selected patients under aseptic conditions. Full thickness mucoperiosteal Kirkland flap would be raised on both buccal and lingual sides using periosteal elevator. Pocket lining epithelium would be removed and a thorough debridement and root planing would be done in the intrabony defect by using Gracey curettes and universal curettes. After placement of A-PRF in bony defect site the mucoperiosteal flaps would be sutured for complete soft tissue closure.
干预措施: open flap debridement and filled with A-PRF ( Advanced platelet rich fibrin) (Procedure)
open flap debridement and filled with Bioactive glass (Perioglas®)
After phase 1 therapy, surgical procedure would be carried out in the selected patients under aseptic conditions. Full thickness mucoperiosteal Kirkland flap would be raised on both buccal and lingual sides using periosteal elevator. Pocket lining epithelium would be removed and a thorough debridement and root planing would be done in the intrabony defect by using Gracey curettes and universal curettes. After placement of Bioactive glass (Perioglas®) in bony defect site the mucoperiosteal flaps would be sutured for complete soft tissue closure.
干预措施: open flap debridement and filled with Bioactive glass (Perioglas®) (Procedure)
with open flap debridement and filled Bioactive glass (Perioglas®) and A-PRF.
After phase 1 therapy, surgical procedure would be carried out in the selected patients under aseptic conditions. Full thickness mucoperiosteal Kirkland flap would be raised on both buccal and lingual sides using periosteal elevator. Pocket lining epithelium would be removed and a thorough debridement and root planing would be done in the intrabony defect by using Gracey curettes and universal curettes. After placement of Bioactive glass (Perioglas®) along with A-PRF in bony defect site the mucoperiosteal flaps would be sutured for complete soft tissue closure.
干预措施: open flap debridement and filled Bioactive glass (Perioglas®) and A-PRF (Drug)
结局指标
主要结局
probing depth
时间窗: baseline, 3 months, 6 months
change in probing pocket depth
relative attachment level
时间窗: baseline, 3 months, 6 months
change in attachment level
radiographic linear bone change
时间窗: change from baseline to 6 months
radiographic linear bone change through radiographic grid
次要结局
- Plaque index site specific(baseline, 3 months, 6 months)
- Gingival index site specific(baseline, 3 months, 6 months)
研究者
DR SURINDER SACHDEVA
PROFESSOR
Maharishi Markendeswar University (Deemed to be University)