Evaluating Salivary a - Amylase Levels Following Trigona Sp Honey Application To Post Palatoplasty Patients: A Pilot Randomized Clinical Study

Cleft palate is one of the most common craniofacial congenital anomalies requiringmultidisciplinary management. Palatoplasty is performed to restore anatomical continuityof the palate, improve speech development, facilitate swallowing, and minimizepsychosocial impairment. Nevertheless, postoperative wound healing may contribute tofibrosis, 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 maycompromise postoperative outcomes. Therefore, identifying effective wound dressings andreliable biomarkers for monitoring healing is clinically important in oral andmaxillofacial surgery.Trigona sp. honey has demonstrated antibacterial, antioxidant, and anti‐inflammatoryeffects attributed to its flavonoid and phenolic content. These properties may enhancetissue regeneration and reduce oxidative stress during healing. Framycetin sulfatedressing, an aminoglycoside antibiotic, is widely used to prevent bacterial colonizationin surgical wounds. Furthermore, buccal fat pad application has been reported to improvevascularization, accelerate epithelialization, and reduce postoperative complications incleft palate repair.Salivary α‐amylase is a non‐invasive biomarker associated with sympathetic nervous systemactivation and inflammatory response. Increased α‐amylase levels may reflect acutepostoperative stress and inflammation, whereas decreasing levels may indicate progressiontoward tissue proliferation and healing. Saliva collection is simple, painless, andpractical for pediatric patients, making it a promising diagnostic tool for postoperativemonitoring.This prospective pilot randomized clinical study with sample size estimation usingG*Power version 3.1 determined a minimum of 24 participants patients diagnosed withunilateral cleft palate aged 18 months to 6,5 years who undergo palatoplasty using thetwo‐flap push‐back technique under general anesthesia between June 2024 and June 2025 atHasanuddin University Dental Hospital and Celebes Cleft Centre Foundation, Makassar,Indonesia. Participants will be randomly allocated into four intervention groups: 1. Trigona sp. honey dressing with buccal fat pad technique 2. Trigona sp. honey dressing without buccal fat pad technique 3. Framycetin sulfate dressing with buccal fat pad technique 4. Framycetin sulfate dressing without buccal fat pad techniqueSalivary α‐amylase levels will be measured preoperatively and on postoperatively and onthe fourth and seventh days postoperatively using ELISA analysis. Clinical follow‐up willevaluate wound healing, epithelialization, bleeding, infection, dehiscence, and adversereactions.The primary outcome is the change in salivary α‐amylase levels among treatment groupsover time. Secondary outcomes include clinical wound healing assessment and postoperativecomplication rates. The findings of this study are expected to support the development ofnon‐invasive biomarkers for wound healing evaluation and explore Trigona sp. honey as asafe and economical alternative dressing material in post‐palatoplasty management.