Evaluating Salivary α - 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 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:

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 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.