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Evaluating Salivary α - Amylase Levels Following Trigona Sp Honey Application To Post Palatoplasty Patients: A Pilot Randomized Clinical Study
Sponsor: Hasanuddin University
Summary
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.
Key Details
Gender
All
Age Range
18 Months - 78 Months
Study Type
INTERVENTIONAL
Enrollment
24
Start Date
2024-06-01
Completion Date
2025-08-06
Last Updated
2026-05-28
Healthy Volunteers
No
Interventions
Trigona sp honey with 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 After oral mucosa sutures, the buccal fat pad was retracted and sutured to the lateral defect
framicetyn sulfate dressing with 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
Trigona sp. honey dressing without 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
framicetyn sulfate dressing without 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.
Locations (1)
Hasanuddin University Dental Hospital
Makassar, South Sulawesi, Indonesia