Salivary α-Amylase as a Non-Invasive Biomarker of PRF-Enhanced Wound Healing After Third Molar Surgery
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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South Sulawesi
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Makassar、South Sulawesi、インドネシア
- Dental Hospital of Hasanuddin University
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参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：PRF Group
Participants in this arm underwent mandibular third molar surgery followed by platelet-rich fibrin (PRF) placement in the extraction socket before suturing.
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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.
他の名前：
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介入なし：Non-PRF Control Group
Participants in this arm underwent the same mandibular third molar surgical procedure without platelet-rich fibrin (PRF) placement.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Mean Salivary α-Amylase Activity in PRF and Non-PRF Groups After Mandibular Third Molar Surgery
時間枠：Postoperative days 0, 3, and 7
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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.
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Postoperative days 0, 3, and 7
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Fauzi, DDS., MDSc.、Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Hasanuddin University
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- PRF-SAA-UNHAS-2024
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
IPD 共有時間枠
IPD 共有アクセス基準
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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