跳至主要内容
临床试验/CTRI/2025/06/089580
CTRI/2025/06/089580尚未招募Phase 3 4

Evaluation and Comparison of Postoperative outcome of intra socket placement of Platelet Rich Fibrin with and without Collagen Plug following removal of Impacted Mandibular Third Molar - A Split Mouth Study.

Datta Meghe Institute of Higher Education and Research1 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2025年7月30日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
11
试验地点
1
主要终点
Less post operative pain, Better post operative soft tissue healing and bone regeneration

研究概览

简要总结

BackgroundImpacted mandibular third molars are frequently encountered in dental practice, often due to limited space between the second molar and the mandibular ramus. Their removal can lead to complications such as bone loss, pain, swelling, periodontal issues, and delayed healing of adjacent structures.

Platelet Rich Fibrin PRF: An autologous healing aid rich in growth factors that enhance tissue repair through angiogenesis, collagen formation, and cellular activity. However, its preparation requires expensive centrifugation equipment.

Collagen Plug: A bioabsorbable scaffold that enhances tissue healing and bone regeneration. It is easy to use and helps maintain the integrity of the socket post-extraction.

AimTo evaluate and compare the postoperative effects of intra-socket placement of PRF with and without a collagen plug after removal of impacted mandibular third molars.


ObjectivesTo evaluate PRF alone in terms of

  1. Pain
  2. Swelling
  3. Soft tissue healing
  4. Bone regeneration

To evaluate PRF and Collagen Plug for the same postoperative outcomes. To compare both groups to assess which approach leads to improved healing and regeneration METHOD This is a prospective randomized split-mouth clinical study comparing healing outcomes after impacted mandibular third molar extraction using Platelet Rich Fibrin  alone versus Platelet Rich Fibrin combined with a collagen plug. Key parameters assessed include pain, swelling, soft tissue healing, and bone regeneration. The goal is to determine whether the addition of a collagen plug enhances postoperative healing compared to PRF alone.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 1.Patients indicated for Surgical Extraction of Impacted bilateral mandibular third molar 2.A medical history devoid of any Pharmacology therapy able to introduce variable into experiments.

排除标准

  • 1.All patients with uncontrolled systemic diseases.
  • 2.Patients who are allergic to materials used during procedure.
  • 3.Patients with Diabetes Mellitus, Coronary Artery Disease, Peripheral Vascular Diseases & Cancer.
  • 4.Patients on Long term Corticosteroid therapy.
  • 5.Patients with immunocompromised status.
  • 6.Pregnant and Lactating females 7.Patients with peri apical infections or cyst involving mandibular third molar.

结局指标

主要结局

Less post operative pain, Better post operative soft tissue healing and bone regeneration

时间窗: Assessment will be done on Post operative Day 1, Day 3, Day 7, Day 14 and after 3 months

次要结局

  • Reduced Post operative Swelling(Assessment will be done on Post operative Day 1, Day 3, Day 7)

研究者

发起方
Datta Meghe Institute of Higher Education and Research
申办方类型
Private medical college

研究点 (1)

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