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临床试验/CTRI/2025/01/079226
CTRI/2025/01/079226尚未招募3 期

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

Dr Enakshi Yadav1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年2月10日最近更新:

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

发起方
Dr Enakshi Yadav
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Enakshi Yadav

Subharti Dental College and Hospital

研究点 (1)

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