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

NCT07600619 | Completed

• 1 other identifier: PRF-SAA-UNHAS-2024
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Platelet-Rich Fibrin (PRF); Impacted Mandibular Third Molar; Postoperative Wound Healing; Salivary Alpha Amylase

Keywords

oral surgery; Salivary α-Amylase; Platelet-Rich Fibrin; Mandibular Third Molar Surgery; Postoperative Wound Healing; Salivary Biomarker

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

PRF Group

EXPERIMENTAL

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

Non-PRF Control Group

NO INTERVENTION

Participants in this arm underwent the same mandibular third molar surgical procedure without platelet-rich fibrin (PRF) placement.

Interventions

PRF group BIOLOGICAL

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.

Also known as: Autologous Platelet-Rich Fibrin

PRF Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hasanuddin University: lead

Study Sites (1)

Dental Hospital of Hasanuddin University

Makassar, South Sulawesi, Indonesia

Location

Study Officials

• Fauzi, DDS., MDSc.

  Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Hasanuddin University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Not applicable. No masking was applied in this study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Oral and Maxillofacial Resident

Model Details: Two-arm parallel randomized study comparing PRF placement with no PRF after mandibular third molar surgery.

Study Record Dates

• First Submitted: May 11, 2026
• First Posted: May 20, 2026
• Study Start: May 12, 2024
• Primary Completion: November 24, 2024
• Study Completion: December 22, 2024
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be available beginning 6 months after publication and will remain available for 5 years.
• 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.

Locations

ID (1)