Treatment of Periodontal Intrabony Defects Using Autologous Platelet Rich Fibrin and Titanium Platelet Rich Fibrin: A Randomized Clinical Comparative Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 4
- 主要终点
- defect depth reduction (DDR)
研究概览
简要总结
Background: To compare the effectiveness of open flap debridement (OFD) alone and OFD along with either Autologous Platelet Rich Fibrin (PRF) or Titanium Platelet Rich Fibrin (TPRF) in the treatment of intrabony defects (IBDs).
Materials and methods: Study was conducted on subjects reporting to the Department of Periodontics, The Oxford Dental College and Hospital, Bangalore. 38 subjects with 90 periodontal IBDs of moderate to severe periodontitis were selected and assigned to OFD alone (group I) or OFD with Autologous PRF (group II) or OFD with TPRF (group III). In each subject, a minimum number of two sextants were present with probing pocket depths (PPD) ≥5mm in at least three teeth.
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
- 20 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •presence of minimum 20 permanent teeth
- •age group 20-55 years
- •radiographic evidence of periodontal IBDs
- •probing pocket depth (PPD) >5mm in minimum two sextants in at least three teeth
- •clinical attachment (CA) loss of ≥ 3mm.
排除标准
- •Systemically compromised subjects
- •those on medications (corticosteroids/ bisphosphonate therapy) that may interfere with wound healing
- •grade III tooth mobility
- •smokers and alcoholic subjects
- •pregnant and lactating mothers
- •subjects who underwent periodontal treatment within a period of 1 year.
结局指标
主要结局
defect depth reduction (DDR)
时间窗: Change from baseline to 9 months
change in clinical attachment level (CAL)
时间窗: Change from baseline to 9 months
次要结局
- 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