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Salivary α-Amylase as a Non-Invasive Biomarker of PRF-Enhanced Wound Healing After Third Molar Surgery

2026年5月18日 更新者：Faizal Manrapi Tony、Hasanuddin University

This randomized clinical study evaluated salivary α-amylase as a non-invasive biomarker of early wound healing after mandibular third molar surgery. The study compared patients who received platelet-rich fibrin (PRF) in the extraction socket with patients who received standard surgical treatment without PRF.

PRF is a material prepared from the patient's own blood and is used to support tissue healing after surgery. Salivary α-amylase is an enzyme found in saliva that may reflect postoperative stress, inflammation, or healing responses. In this study, saliva samples were collected on postoperative days 0, 3, and 7 to measure α-amylase activity.

The study included adult patients aged 18 to 60 years who underwent impacted mandibular third molar surgery at the Dental Hospital of Hasanuddin University, Makassar, Indonesia. The main purpose was to determine whether PRF placement changes salivary α-amylase activity compared with no PRF during the first postoperative week.

研究概览

地位

完全的

条件

干预/治疗

详细说明

This study was designed to evaluate whether platelet-rich fibrin (PRF) placement after impacted mandibular third molar surgery is associated with changes in salivary α-amylase activity during the early postoperative healing period.

Salivary α-amylase was selected because saliva provides a non-invasive medium for monitoring biological responses after oral surgery. PRF was used as an autologous material prepared from the patient's own blood and placed into the extraction socket before suturing. The comparison group underwent the same surgical procedure without PRF placement.

Participants were assigned to two parallel groups: a PRF group and a non-PRF group. Saliva samples were collected during the first postoperative week, specifically on postoperative days 0, 3, and 7. The study compared salivary α-amylase activity between groups and also described changes over time within each group.

The study was conducted at the Dental Hospital of Hasanuddin University, Makassar, Indonesia. Laboratory analysis of salivary α-amylase was performed at the HumRC Laboratory, Faculty of Medicine, Hasanuddin University. The findings are intended to clarify whether salivary α-amylase can serve as a useful non-invasive biomarker for monitoring early wound healing after PRF-assisted mandibular third molar surgery.

研究类型

介入性

注册 (实际的)

28

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

  • 印度尼西亚
    • South Sulawesi
      • Makassar、South Sulawesi、印度尼西亚
        • Dental Hospital of Hasanuddin University

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

不

描述

Inclusion Criteria:

  • Patients aged 18-35 years.
  • Patients requiring surgical extraction of impacted mandibular third molars.
  • Patients classified as American Society of Anesthesiologists Physical Status Classification class I or II.
  • Patients who are willing to participate and provide written informed consent.
  • Patients able to comply with study procedures and follow-up visits.

Exclusion Criteria:

  • Patients with systemic diseases that may affect wound healing or inflammatory response (e.g., Diabetes Mellitus, immunodeficiency disorders).
  • Patients currently using anti-inflammatory drugs, corticosteroids, or antibiotics within the last 7 days before surgery.
  • Patients with active oral infection or severe periodontal disease at the surgical site.
  • Patients with a history of smoking or tobacco use.
  • Pregnant or breastfeeding women.
  • Patients with salivary gland disorders or conditions affecting salivary secretion.
  • Patients with known bleeding disorders or currently receiving anticoagulant therapy.
  • Patients with allergy or contraindication to materials or medications used during the procedure.

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：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：PRF Group
Participants in this arm underwent mandibular third molar surgery followed by platelet-rich fibrin (PRF) placement in the extraction socket before suturing.
生物：PRF group
Platelet-rich fibrin (PRF) was prepared from the participant's own venous blood. A 10 mL blood sample was collected into dry sterile glass tubes without anticoagulant and centrifuged at 2700 rpm for 12 minutes. The resulting PRF clot was compressed into a thin fibrin membrane and placed into the mandibular third molar extraction socket before suturing. The intervention was used as an autologous biologic material to support postoperative wound healing after mandibular third molar surgery.
其他名称：
  • 自体富血小板纤维蛋白
无干预：Non-PRF Control Group
Participants in this arm underwent the same mandibular third molar surgical procedure without platelet-rich fibrin (PRF) placement.

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
Mean Salivary α-Amylase Activity in PRF and Non-PRF Groups After Mandibular Third Molar Surgery
大体时间：Postoperative days 0, 3, and 7
Unstimulated saliva samples will be collected and salivary α-amylase activity will be measured in both groups. Measurements will be performed on postoperative day 0, day 3, and day 7, and mean values will be compared between the PRF and non-PRF groups.
Postoperative days 0, 3, and 7

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。

赞助

Hasanuddin University

调查人员

  • 首席研究员：Fauzi, DDS., MDSc.、Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Hasanuddin University

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)

2024年5月12日

初级完成 (实际的)

2024年11月24日

研究完成 (实际的)

2024年12月22日

研究注册日期

首次提交

2026年5月11日

首先提交符合 QC 标准的

2026年5月18日

首次发布 (实际的)

2026年5月20日

研究记录更新

最后更新发布 (实际的)

2026年5月20日

上次提交的符合 QC 标准的更新

2026年5月18日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • PRF-SAA-UNHAS-2024

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

De-identified individual participant data underlying the reported results will be shared upon reasonable request, including demographic and clinical characteristics, group assignment, and salivary α-amylase activity values on postoperative days 0, 3, and 7. No direct participant identifiers will be shared.

IPD 共享时间框架

Data will be available beginning 6 months after publication and will remain available for 5 years.

IPD 共享访问标准

Qualified researchers may request access to de-identified individual participant data supporting the reported results. Requests must be submitted by email to the corresponding author with a brief research proposal and will be reviewed by the study team. Data will be shared only for scientifically valid purposes and without direct participant identifiers.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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.

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