Clinical and Radiographic Evaluation of Irradiated Allogenic Bone Graft (RMTB-TM) In The Treatment Of Intrabony Defects In Patients With Chronic Periodontitis.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- 1.Probing pocket depth
研究概览
简要总结
1.The ultimate goal of regenerative therapy is to restore the lost tissues with a functional attachment apparatus. Although bone tissues exhibit a large regenerative potential and may restore its original structure and function completely, bone defects often fail to heal with bone tissue. In order to facilitate or promote healing, bone grafting materials have been placed into bony defects.
- Mineralized bone allografts have been studied as an augmentation material for maxillary sinus graft, ridge augmentation and extraction sites but limited information is available as to how these grafts materials perform in periodontal Intrabony defects.
3.The present study is designed to evaluate clinically and radiographically the efficacy of irradiated allogenic bone graft (RMTB TM) in the treatment of Intrabony defects post surgically over a 9 months period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 25.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Systemically healthy patients 2.Moderate to severe chronic periodontitis as defined by the AAP classification
- •3.Probing Pocket Depth > 5mm, Radiographic defects > 3mm of 2 wall, 3 wall or combination defects.
排除标准
- •1.Known drug allergies or Infectious diseases 2.1 wall defects 3.Periodontal treatment or antibiotic therapy in the preceding six months prior to initial examination.
- •4.History of Smoking/Alcohol consumption.
- •5.Pregnant and/or Lactating.
结局指标
主要结局
1.Probing pocket depth
时间窗: 1.Probing pocket depth at baseline, 3, 6, 9 months after periodontal surgery | Radiographic examination at baseline and 9 months after surgery
2.Radiographic bone fill
时间窗: 1.Probing pocket depth at baseline, 3, 6, 9 months after periodontal surgery | Radiographic examination at baseline and 9 months after surgery
次要结局
- 1.Clinical Attachment Level(At baseline, 3, 6, 9 months after periodontal surgery)