Platelet-Rich Fibrin as an Antibiotic Delivery Vehicle in Mandibular Third Molar Surgery
2026年8月18日 更新者：Amerigo Giudice
Effects of Antibiotic-Prepared Platelet-Rich Fibrin on Postoperative Recovery After Mandibular Third Molar Surgery: A Randomized Split-Mouth Clinical Trial
The present study aims to evaluate the effect of platelet-rich fibrin (PRF) used as a local antibiotic delivery vehicle on postoperative outcomes, including facial swelling, trismus, and pain, following mandibular third molar surgery in a randomized split-mouth clinical trial.
研究概览
地位
主动，不招人
研究类型
介入性
注册 (实际的)
31
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
cz
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Catanzaro、cz、意大利、88100
- Magna Graecia University of Catanzaro
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
接受健康志愿者
是的
描述
Inclusion Criteria:
- Healthy patients (ASA I) according to the American Society of Anesthesiologists classification.
- Age 18-32 years.
- Ability to provide written informed consent.
- Bilateral mandibular third molars requiring extraction for prophylactic, therapeutic, or strategic reasons.
- Complete root development of mandibular third molars (Shumaker Stage H).
- Availability of diagnostic-quality CBCT scans with adequate field of view (17 × 20).
- Mandibular third molars classified as having conventional or moderate surgical difficulty according to Juodzbalys and Daugela classification.
Exclusion Criteria:
- Known allergy to corticosteroids.
- Immunosuppression or immunocompromised conditions.
- Acute infection at the mandibular third molar extraction sites.
- Current or previous intravenous amino-bisphosphonate therapy.
- Psychiatric disorders.
- Thrombocytopenia (platelet count <40,000/µL), thrombocytosis, or other coagulation disorders.
- Severe hepatic cirrhosis, advanced chronic renal failure, or uncontrolled -diabetes mellitus.
- Pregnancy or breastfeeding.
- Requirement for additional regenerative procedures (e.g., bone grafting).
- Localized facial malformations involving the cheek region.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Test Group - Antibiotic and PRF
Participants will receive platelet-rich fibrin prepared with the addition of antibiotic prior to centrifugation.
The antibiotic-enriched PRF clot will be placed into the mandibular third molar extraction socket to provide local antibiotic delivery at the surgical site.
|
Platelet-rich fibrin prepared with the addition of antibiotic prior to centrifugation and applied into the mandibular third molar extraction socket to provide local antibiotic delivery.
|
|
有源比较器：Control Group - PRF only
Participants will receive standard platelet-rich fibrin prepared without antibiotic addition.
The PRF clot will be placed into the mandibular third molar extraction socket according to the same surgical protocol.
|
Standard platelet-rich fibrin prepared without antibiotic addition and applied into the mandibular third molar extraction socket.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Incidence of postoperative infection
大体时间：Up to 7 days after surgery
|
Occurrence of postoperative infection following mandibular third molar surgery, assessed through clinical examination based on the presence of signs and symptoms of infection (e.g., purulent discharge, erythema, fever, or need for additional antibiotic therapy).
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Up to 7 days after surgery
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Facial swelling quantitative analysis - volumetric differences
大体时间：Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery
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To compare postoperative facial swelling between treatment groups using quantitative three-dimensional analysis based on volumetric differences.
Facial volume changes will be measured in cubic centimeters (cm³) through three-dimensional facial scan superimposition.
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Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery
|
|
Facial swelling quantitative analysis - linear differences
大体时间：Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery
|
To compare postoperative facial swelling between treatment groups using quantitative three-dimensional analysis based on linear measurements.
Facial changes will be assessed by evaluating linear differences (mm) between preoperative and postoperative three-dimensional facial scans.
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Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery
|
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Facial swelling qualitative analysis
大体时间：Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery
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Change in facial volume from baseline, assessed by three-dimensional facial scan superimposition and expressed as colorimetric variation between the preoperative and postoperative scans.
|
Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Trismus analysis
大体时间：Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery
|
To compare postoperative limitation of mouth opening between treatment groups following mandibular third molar surgery.
Trismus will be assessed by measuring maximum mouth opening (MMO) in millimeters (mm).
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Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery
|
|
Pain analysis with Visual analogue scale (VAS)
大体时间：Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery
|
To compare postoperative pain intensity between treatment groups following mandibular third molar surgery.
Pain will be assessed using a Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst possible pain).
|
Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2025年11月1日
初级完成 (估计的)
2026年9月1日
研究完成 (估计的)
2026年11月20日
研究注册日期
首次提交
2026年8月10日
首先提交符合 QC 标准的
2026年8月10日
首次发布 (实际的)
2026年8月14日
研究记录更新
最后更新发布 (实际的)
2026年8月20日
上次提交的符合 QC 标准的更新
2026年8月18日
最后验证
2026年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.