Salivary α-Amylase as a Non-Invasive Biomarker of PRF-Enhanced Wound Healing After Third Molar Su… (NCT07600619) | Clinical Trial Compass
CompletedNot Applicable
Salivary α-Amylase as a Non-Invasive Biomarker of PRF-Enhanced Wound Healing After Third Molar Surgery
Indonesia28 participantsStarted 2024-05-12
Plain-language 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.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mean Salivary α-Amylase Activity in PRF and Non-PRF Groups After Mandibular Third Molar Surgery