Platelet-Rich Fibrin (PRF)NCT07600619
Salivary α-Amylase as a Non-Invasive Biomarker of PRF-Enhanced Wound Healing After Third Molar Surgery
A study testing PRF group in people with Platelet-Rich Fibrin (PRF) and Impacted Mandibular Third Molar, run by Hasanuddin University at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Platelet-Rich Fibrin (PRF), Impacted Mandibular Third Molar, Postoperative Wound Healing
- What is being tested?
- PRF group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteIndonesia
- Study dates
- 12 May 2024to 22 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Dental Hospital of Hasanuddin University
Makassar, South Sulawesi
About this study
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.
- Conditions
- Platelet-Rich Fibrin (PRF), Impacted Mandibular Third Molar, Postoperative Wound Healing, Salivary Alpha Amylase
- Being tested
- PRF group
- Keywords
- oral surgery, Salivary α-Amylase, Platelet-Rich Fibrin, Mandibular Third Molar Surgery, Postoperative Wound Healing, Salivary Biomarker
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRF groupBiological
Also called Autologous Platelet-Rich Fibrin
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Postoperative days 0, 3, and 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start12 May 2024
- Primary completion24 Nov 2024
- Study completion22 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Platelet-Rich Fibrin (PRF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm parallel randomized study comparing PRF placement with no PRF after mandibular third molar surgery.
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasanuddin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Faizal Manrapi Tony, Hasanuddin University
- Investigators
- Fauzi, DDS., MDSc., Principal investigator, Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Hasanuddin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07600619
- Sponsor's protocol ID
- PRF-SAA-UNHAS-2024
- Status last verified
- May 2026
- First submitted
- 11 May 2026
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Salivary α-Amylase as a Non-Invasive Biomarker of PRF-Enhanced Wound Healing After Third Molar Surgery
- ClinicalTrials.gov ID
- NCT07600619
- Acronym / sponsor ID
- PRF-SAA-UNHAS-2024
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Hasanuddin UniversityUniversity, hospital or other
- Study start
- 12 May 2024 (actual)
- Primary completion
- 24 Nov 2024 (actual)
- Study completion
- 22 Dec 2024 (actual)
- First posted
- 20 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two-arm parallel randomized study comparing PRF placement with no PRF after mandibular third molar surgery.
| Arm | Type | Receives |
|---|---|---|
| PRF Group | Experimental | Biological: PRF groupParticipants in this arm underwent mandibular third molar surgery followed by platelet-rich fibrin (PRF) placement in the extraction socket before suturing. |
| Non-PRF Control Group | No intervention | –Participants in this arm underwent the same mandibular third molar surgical procedure without platelet-rich fibrin (PRF) placement. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRF groupAlso: Autologous Platelet-Rich FibrinPlatelet-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. | Biological | PRF Group |
Primary outcome
Mean Salivary α-Amylase Activity in PRF and Non-PRF Groups After Mandibular Third Molar Surgery
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Individual participant dataSharing planned: 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.
Related trials for Platelet-Rich Fibrin (PRF)
Active, not recruiting
L-PRF Block vs Composite Graft for Horizontal Ridge Augmentation
Alveolar Ridge Resorption After Extraction, Alveolar Bone Loss
Recruiting
i-PRF-Based Bioactive Matrix vs. Connective Tissue Graft in the Treatment of Gingival Recessions
Gingival Graft, Recession, Gingival
Not yet recruiting
Effect of Ascorbic Acid-Loaded I-PRF With Partially Demineralized Dentin Graft on Alveolar Ridge Preservation
Alveolar Ridge Preservation Post-Extraction Bone Healing Dental Implant Site Development Tooth Loss, Alveolar Bone Regeneration Following Odontectomy
Not yet recruiting
Microneedling-Assisted i-PRF for Interdental Papilla Deficiency
Interdental Papilla Deficiency
Not yet recruiting
Clinical and Inflammatory Outcomes of Regenerative Endodontic Treatment Using Injectable Platelet-Rich Fibrin in Mature Necrotic Teeth With Chronic Apical Periodontitis.
Chronic Apical Periodontitis, Pulp Necrosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fauzi, DDS., MDSc. principal investigator
Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Hasanuddin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRF group in people with Platelet-Rich Fibrin (PRF) and Impacted Mandibular Third Molar, run by Hasanuddin University at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Salivary α-Amylase Activity in PRF and Non-PRF Groups After Mandibular Third Molar Surgery (time frame: Postoperative days 0, 3, and 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.