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

Hasanuddin University

Status: Completed

Conditions: Cleft Palate; Salivary Alpha Amylase; Honey; Buccal Fat Pad

Treatments: Combination Product: framicetyn sulfate dressing with the buccal fat pad technique; Drug: framicetyn sulfate dressing without the buccal fat pad technique; Combination Product: Trigona sp honey with the buccal fat pad technique; Dietary Supplement: Trigona sp. honey dressing without the buccal fat pad technique

Study type: Interventional

Funder types: Other

Identifiers

NCT07610993

No. 074/KEPK FKG-RSGMP UH/EA/I

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 78 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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24 participants in 4 patient groups

Trigona sp. honey dressing with the buccal fat pad technique

Experimental group

Description:

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

Treatment:

Combination Product: Trigona sp honey with the buccal fat pad technique

Trigona sp. honey dressing without the buccal fat pad technique

Experimental group

Description:

Participants in this arm underwent palatoplasty using the two-flap push-back technique under general anesthesia followed by trigona sp honey dressing

Treatment:

Dietary Supplement: Trigona sp. honey dressing without the buccal fat pad technique

framicetyn sulfate dressing with the buccal fat pad technique

Experimental group

Description:

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

Treatment:

Combination Product: framicetyn sulfate dressing with the buccal fat pad technique

framicetyn sulfate dressing without the buccal fat pad technique

Experimental group

Description:

Participants in this arm underwent palatoplasty using the two-flap push-back technique under general anesthesia followed by framicetyn sulfate dressing

Treatment:

Drug: framicetyn sulfate dressing without the buccal fat pad technique