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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Wound Healing; Salivary Alpha Amylase; Impacted Mandibular Third Molar; Platelet-Rich Fibrin (PRF)
• Intervention / Treatment: Biological: PRF group

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • South Sulawesi
    • Makassar, South Sulawesi, Indonesia
      • Dental Hospital of Hasanuddin University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PRF Group; Participants in this arm underwent mandibular third molar surgery followed by platelet-rich fibrin (PRF) placement in the extraction socket before suturing.	Biological: 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.; Other Names: Autologous Platelet-Rich Fibrin
No Intervention: Non-PRF Control Group; Participants in this arm underwent the same mandibular third molar surgical procedure without platelet-rich fibrin (PRF) placement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Salivary α-Amylase Activity in PRF and Non-PRF Groups After Mandibular Third Molar Surgery	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

Collaborators and Investigators

• Sponsor: Hasanuddin University
• Investigators: Principal Investigator: Fauzi, DDS., MDSc., Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Hasanuddin University

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2024
• Primary Completion (Actual): November 24, 2024
• Study Completion (Actual): December 22, 2024

Study Registration Dates

• First Submitted: May 11, 2026
• First Submitted That Met QC Criteria: May 18, 2026
• First Posted (Actual): May 20, 2026

Study Record Updates

• Last Update Posted (Actual): May 20, 2026
• Last Update Submitted That Met QC Criteria: May 18, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Platelet-Rich Fibrin; oral surgery; Salivary Biomarker; Mandibular Third Molar Surgery; Salivary α-Amylase; Postoperative Wound Healing
• Other Study ID Numbers: PRF-SAA-UNHAS-2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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 Sharing Time Frame: Data will be available beginning 6 months after publication and will remain available for 5 years.
• IPD Sharing Access Criteria: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No