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

18 maj 2026 uppdaterad av: 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.

Studieöversikt

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

28

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen

Tar emot friska volontärer

Nej

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: PRF Group
Participants in this arm underwent mandibular third molar surgery followed by platelet-rich fibrin (PRF) placement in the extraction socket before suturing.
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.
Andra namn:
  • Autologt plättrik fibrin
Inget ingripande: Non-PRF Control Group
Participants in this arm underwent the same mandibular third molar surgical procedure without platelet-rich fibrin (PRF) placement.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Mean Salivary α-Amylase Activity in PRF and Non-PRF Groups After Mandibular Third Molar Surgery
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: Fauzi, DDS., MDSc., Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Hasanuddin University

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

12 maj 2024

Primärt slutförande (Faktisk)

24 november 2024

Avslutad studie (Faktisk)

22 december 2024

Studieregistreringsdatum

Först inskickad

11 maj 2026

Först inskickad som uppfyllde QC-kriterierna

18 maj 2026

Första postat (Faktisk)

20 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

20 maj 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

18 maj 2026

Senast verifierad

1 maj 2026

Mer information

Termer relaterade till denna studie

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

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.

Tidsram för IPD-delning

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

Kriterier för IPD Sharing Access

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.

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Nej

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Nej

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