Comparative Evaluation Of Free Dried Bone Allograft (FDBA) With and Without i-PRF (Injectable Platelet Rich Fibrin) In The Treatment of Human Intrabony Defects- A Clinico-Radiographic Study
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- To Evaluate And Compare The Reduction In Probing Pocket Depth Of Intrabony Defects With Fdba and iPRF with FDBA
研究概览
简要总结
Group A (FDBA Group): A patient meeting the inclusion criteria from the Periodontology department was inducted into the study. After informed consent, Phase 1 therapy was completed, followed by re-evaluation and recording of Relative Attachment Level (RAL).
- Surgical Protocol:
- Intra-oral asepsis using 0.2% chlorhexidine and extra-oral asepsis with povidone-iodine.
- Crevicular incision and reflection of a full-thickness mucoperiosteal flap, preserving interdental tissues.
- Degranulation and root planing confirmed the presence of an intra-bony defect (IBD).
- Freeze-Dried Bone Allograft (FDBA) was procured from the Tissue Bank at Tata Memorial Hospital, mixed with saline, placed, and condensed into the defect.
- Sutures were placed, and patients were recalled for suture removal after one week and for follow-up at 3 and 6 months.
Group B (Fdba with iPRF): A similar protocol was followed for patients in this group, using FDBA with iPRF.
- Surgical Protocol:
- Phase 1 therapy, RAL measurement, asepsis, and flap reflection were conducted as described.
- The defect was filled with FDBA with iPRF, followed by suturing.
- Patients were recalled after 1 week for suture removal and follow-ups at 3 and 6 months.
Postoperative Care for Both Groups:
- Patients were prescribed oral hygiene instructions, antibiotics, and analgesics for 5 days.
- Oral hygiene instructions were reinforced during the 7-day recall visit.
Outcome Measurements: Baseline, 3-month, and 6-month clinical and radiographic assessments were recorded for statistical analysis. Remaining cases for test and control groups were conducted following the same methodology for comparative evaluation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 25.00 Year(s) 至 50.00 Year(s)(—)
- 性别
- All
入选标准
- •Good level of oral hygiene
- •Subjects of either sex having generalised Chronic Periodontitis
- •Subjects who are systemically healthy with no contraindication to periodontal surgery
- •Presence of PD 5mm in relation to with radiographic evidence of angular bone loss
- •Compliant subjects.
排除标准
- •Subjects with any systemic disease.
- •Individuals having any deleterious habits such as smoking or tobacco chewing
- •Subjects allergic or sensitive to any medication or any ingredient of the test material
- •Subjects showing unacceptable oral hygiene compliance during or after phase I therapy
- •Pregnant or lactating females
- •Subjects who have undergone any periodontal surgery in the past 6 months.
结局指标
主要结局
To Evaluate And Compare The Reduction In Probing Pocket Depth Of Intrabony Defects With Fdba and iPRF with FDBA
时间窗: At Baseline And 6 Months
次要结局
- To Evaluate And Compare Gain In Bone Fill Achieved By The above Modalities Using Pre And Post Rvg(Baseline And 3 Months And 6 Months)
研究者
Enakshi Yadav
Subharti Dental College and Hospital
