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临床试验/CTRI/2025/12/099872
CTRI/2025/12/099872尚未招募2 期

A comparison of the efficacy of advanced platelet-rich fibrin and leukocyte platelet-rich fibrin on postoperative pain, swelling, trismus, and soft tissue wound healing after removal of impacted mandibular third molar: A randomized controlled trial.

Dr Jyotsna1 个研究点 分布在 1 个国家目标入组 144 人开始时间: 2026年1月21日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
144
试验地点
1

研究概览

简要总结

Impacted mandibular third molar removal is commonly associated with post-operative pain, swelling, trismus, and delayed soft-tissue wound healing. Autologous platelet-rich fibrin (PRF) has been shown to enhance healing and reduce post-operative morbidity. This study is designed to compare the efficacy of advanced platelet-rich fibrin (APRF) and leukocyte-platelet rich fibrin (LPRF) in reducing post-operative pain, swelling, trismus, and improving soft-tissue wound healing following surgical removal of impacted mandibular third molars. This is a randomized, parallel-group, interventional clinical trial in which eligible participants will be randomly allocated to receive either APRF or LPRF at the extraction site. Post-operative pain will be assessed as the primary outcome, while swelling, trismus, and soft-tissue wound healing will be evaluated as secondary outcomes at predefined post-operative time points.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)
性别
All

入选标准

  • Patients between age of 18-45 years of both genders.
  • Patients indicated for surgical removal of moderately difficult impacted mandibular third molar as per Modified Pederson’s Index.
  • Healthy patients falling under ASA I and ASA II
  • Subjects able and willing to provide written informed consent and compliant with study procedure.

排除标准

  • Patients with mouth opening less than 30mm.
  • Patient with allergy with NSAIDS.
  • Patients having history of drug abuse.
  • Patients having any systemic or local immunodeficiency.
  • Patient is under regular analgesics and anti-depressants.
  • Having any blood coagulation impairment.
  • Presence of any acute oral infection.
  • Have been suffering with uncontrolled diabetes or other systemic diseases.
  • Having previous history of radiation therapy in the head and neck region.
  • Pregnant and nursing women.
  • Patient with the history of smoking and alcohol.
  • Soft tissue impactions.

研究者

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

Dr. Jyotsna

Geetanjali Dental and Research institute

研究点 (1)

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