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CompletedNCT07600619Updated May 20, 2026

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

An interventional study of PRF group in Platelet-Rich Fibrin (PRF), Impacted Mandibular Third Molar and Postoperative Wound Healing, sponsored by Hasanuddin University. Completed at 1 site in Indonesia. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-05-20.

Sponsored by Hasanuddin University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 11 months after the study started (first participant enrolled May 2024, registered May 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
28
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • 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
03

In context

Lead sponsor

Hasanuddin University is the lead sponsor of 65 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
28 participants (actual)

Study arms

  • 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

  • No intervention
    Non-PRF Control Group

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

Interventions

  • BiologicalPRF 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.

    Also known as: Autologous Platelet-Rich Fibrin

06

What researchers measure

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.

    Time frame: Postoperative days 0, 3, and 7

07

Study locations

1 site
  • Dental Hospital of Hasanuddin University
    Makassar, South Sulawesi, Indonesia
08

References and documents

Study documents

  • Protocol and statistical analysis plan · Jan 15, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — 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.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07600619
Lead sponsor
Hasanuddin University
Responsible party
Faizal Manrapi Tony (Oral and Maxillofacial Resident, Hasanuddin University) — Principal investigator
First posted
May 20, 2026
Start date
May 12, 2024
Primary completion
Nov 24, 2024
Completion
Dec 22, 2024
Last update
May 20, 2026

Study contacts

Fauzi, DDS., MDSc.
principal investigator · Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Hasanuddin University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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