跳至主要内容
临床试验/NCT06545084
NCT06545084招募中不适用

Evaluation of Periapical Healing Following Endodontic Microsurgery With Leukocyte and Platelet Rich Fibrin (L-PRF)

University of Pennsylvania1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
1
主要终点
Peri-radicular Healing

研究概览

简要总结

The purpose of the study is to evaluate peri-radicular healing after root-end surgery using Leukocyte and Platelet Rich Fibrin. The study population includes patients diagnosed with persistent periapical pathology and scheduled for Endodontic Microsurgery at the University of Pennsylvania School of Dental Medicine, Department of Endodontics. Patients undergoing routine endodontic microsurgery and who meet the inclusion criteria will be given the opportunity to opt in to receive L-PRF in the osteotomy site to promote bone formation. Healing will be assessed radiographically and clinically at six, twelve, eighteen, and twenty-four months.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Provision of signed and dated informed consent form.
  • Stated willingness to comply with all study procedures and availability for the duration of the study, including the follow-up visits.
  • Male or Female age >18 years old.
  • In good general health (ASA 2 or less) with no contraindications for Endodontic Microsurgery.
  • Persistent endodontic periapical pathology Class A, B, or C according to the Kim and Kratchman classification (5)
  • Intact coronal restorations with no evidence of leakage or caries under the restoration.

排除标准

  • Suspected root fractures.
  • ASA classification 3 or greater.
  • Periapical pathology Class D, E, or F according to the Kim and Kratchman classification (5).
  • Patients with history of Oral or IV Bisphosphonate use.
  • Patients may be excluded if their treatment team do not believe Endodontic microsurgery and L-PRF graft is in the patient's best interests.

结局指标

主要结局

Peri-radicular Healing

时间窗: 12 and 24 months

Evaluate Peri-radicular healing after Endodontic Microsurgery with the use of autologous L-PRF plug.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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