Evaluating Salivary α - Amylase Levels Following Trigona Sp Honey Application To Post Palatoplasty Patients: A Pilot Randomized Clinical Study
Palatoplasty is a surgical procedure performed to restore palatal continuity and improve velopharyngeal function in patients with cleft palate. However, postoperative wound healing may influence scar formation, tissue quality, and maxillary growth. Various topical dressings have been used to reduce bacterial colonization and enhance tissue healing. Trigona sp. honey possesses antimicrobial, antioxidant, and anti-inflammatory properties that may promote wound healing, while framycetin sulfate is a commonly used aminoglycoside antibiotic dressing in palatoplasty. In addition, the buccal fat pad technique may improve tissue vascularization and epithelialization.
This pilot randomized clinical study aims to evaluate salivary α-amylase levels as a non-invasive biomarker of wound healing in post-palatoplasty patients receiving Trigona sp. honey or framycetin sulfate dressings, with or without buccal fat pad application. Salivary α-amylase levels will be measured preoperatively and on the fourth and seventh days postoperatively to assess inflammatory responses and healing dynamics following surgery.
調査の概要
状態
詳細な説明
Cleft palate is one of the most common craniofacial congenital anomalies requiring multidisciplinary management. Palatoplasty is performed to restore anatomical continuity of the palate, improve speech development, facilitate swallowing, and minimize psychosocial impairment. Nevertheless, postoperative wound healing may contribute to fibrosis, scar tissue formation, and impaired maxillary growth.
The wound healing process involves sequential phases including hemostasis, inflammation, proliferation, and remodeling. Excessive inflammation or delayed tissue repair may compromise postoperative outcomes. Therefore, identifying effective wound dressings and reliable biomarkers for monitoring healing is clinically important in oral and maxillofacial surgery.
Trigona sp. honey has demonstrated antibacterial, antioxidant, and anti-inflammatory effects attributed to its flavonoid and phenolic content. These properties may enhance tissue regeneration and reduce oxidative stress during healing. Framycetin sulfate dressing, an aminoglycoside antibiotic, is widely used to prevent bacterial colonization in surgical wounds. Furthermore, buccal fat pad application has been reported to improve vascularization, accelerate epithelialization, and reduce postoperative complications in cleft palate repair.
Salivary α-amylase is a non-invasive biomarker associated with sympathetic nervous system activation and inflammatory response. Increased α-amylase levels may reflect acute postoperative stress and inflammation, whereas decreasing levels may indicate progression toward tissue proliferation and healing. Saliva collection is simple, painless, and practical for pediatric patients, making it a promising diagnostic tool for postoperative monitoring.
This prospective pilot randomized clinical study with sample size estimation using G*Power version 3.1 determined a minimum of 24 participants patients diagnosed with unilateral cleft palate aged 18 months to 6,5 years who undergo palatoplasty using the two-flap push-back technique under general anesthesia between June 2024 and June 2025 at Hasanuddin University Dental Hospital and Celebes Cleft Centre Foundation, Makassar, Indonesia. Participants will be randomly allocated into four intervention groups:
- Trigona sp. honey dressing with buccal fat pad technique
- Trigona sp. honey dressing without buccal fat pad technique
- Framycetin sulfate dressing with buccal fat pad technique
- Framycetin sulfate dressing without buccal fat pad technique
Salivary α-amylase levels will be measured preoperatively and on postoperatively and on the fourth and seventh days postoperatively using ELISA analysis. Clinical follow-up will evaluate wound healing, epithelialization, bleeding, infection, dehiscence, and adverse reactions.
The primary outcome is the change in salivary α-amylase levels among treatment groups over time. Secondary outcomes include clinical wound healing assessment and postoperative complication rates. The findings of this study are expected to support the development of non-invasive biomarkers for wound healing evaluation and explore Trigona sp. honey as a safe and economical alternative dressing material in post-palatoplasty management.
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、90245
- Hasanuddin University Dental Hospital
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参加基準
適格基準
就学可能な年齢
- 子
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- a diagnosis of unilateral cleft palate aged 18 months to 6,5 years.
- Patients undergoing palatoplasty surgery between June 2024 and June 2025 at Hasanuddin University Dental Hospital and Celebes Cleft Centre Foundation, Makassar, Indonesia
- all participants parents agreed and signed an informed consent form to participate in examinations and evaluations through to the end of the study in accordance with research procedures
Exclusion Criteria:
- a history of systemic disease,
- allergies to honey ingredients,
- failure to follow the examination and evaluation until the end according to the research 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：階乗代入
- 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：Trigona sp. honey dressing with the buccal fat pad technique
Participants in this arm underwent palatoplasty using the two-flap push-back technique under general anesthesia followed by trigona sp honey dressing with the use of the buccal fat pad technique
|
a species of stingless bee with the most significant composition of coconut pollen. This honey is one of the natural bioactive ingredients being researched and developed at Hasanuddin University. This honey has gone through the inspection process at the BPOM (Food and Drug Regulatory Agency) and is the standard for food and drug control in Indonesia. the amount of honey applied was ± 5 ml with a note: the condition of the honey absorbs all sides of the sterile gauze, then fixed with an obturator. The buccal fat pad is a complex structure associated with important anatomical structures such as the facial nerve, parotid gland, and masticatory muscles. After oral mucosa sutures, the buccal fat pad was retracted and sutured to the lateral defect
他の名前：
|
|
実験的：Trigona sp. honey dressing without the buccal fat pad technique
Participants in this arm underwent palatoplasty using the two-flap push-back technique under general anesthesia followed by trigona sp honey dressing
|
a species of stingless bee with the most significant composition of coconut pollen.
This honey is one of the natural bioactive ingredients being researched and developed at Hasanuddin University.
This honey has gone through the inspection process at the BPOM (Food and Drug Regulatory Agency) and is the standard for food and drug control in Indonesia.
the amount of honey applied was ± 5 ml with a note: the condition of the honey absorbs all sides of the sterile gauze, then fixed with an obturator
他の名前：
|
|
実験的：framicetyn sulfate dressing with the buccal fat pad technique
Participants in this arm underwent palatoplasty using the two-flap push-back technique under general anesthesia followed by framicetyn sulfate dressing with the use of the buccal fat pad technique
|
The dressing commonly used in palatoplasty is framycetin sulfate (Darya-Varia Laboratory, Gunung Putri, Bogor, Indonesia) , an aminoglycoside antibiotic that works by inhibiting bacterial protein synthesis. framicetyn sulfate was applied according to the size of the obturator to be fixed. The buccal fat pad is a complex structure associated with important anatomical structures such as the facial nerve, parotid gland, and masticatory muscles. After oral mucosa sutures, the buccal fat pad was retracted and sutured to the lateral defect
他の名前：
|
|
実験的：framicetyn sulfate dressing without the buccal fat pad technique
Participants in this arm underwent palatoplasty using the two-flap push-back technique under general anesthesia followed by framicetyn sulfate dressing
|
The dressing commonly used in palatoplasty is framycetin sulfate (Darya-Varia Laboratory, Gunung Putri, Bogor, Indonesia) , an aminoglycoside antibiotic that works by inhibiting bacterial protein synthesis.
framicetyn sulfate was applied according to the size of the obturator to be fixed.
他の名前：
|
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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Change in Salivary α-Amylase Levels Following Palatoplasty
時間枠：Preoperative baseline, postoperative day 4, and postoperative day 7
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Salivary α-amylase levels will be measured using ELISA analysis to evaluate postoperative inflammatory response and wound healing following the application of (1) Trigona sp honey dressing with the buccal fat pad technique, (2) Trigona sp honey dressing without the buccal fat pad technique, (3) framycetin sulfate dressing with the buccal fat pad technique, (4) framycetin sulfate dressing with the buccal fat pad technique in post-palatoplasty patients.
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Preoperative baseline, postoperative day 4, and postoperative day 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：abul Fauzi, DDS., MDS、Department of Oral and Maxillofacial Surgery
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
追加の関連 MeSH 用語
その他の研究ID番号
- No. 074/KEPK FKG-RSGMP UH/EA/I
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
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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