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

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.

Conditions

• Buccal Fat Pad
• Cleft Palate
• Honey
• Salivary Alpha Amylase

Interventions

COMBINATION_PRODUCT

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 After oral mucosa sutures, the buccal fat pad was retracted and sutured to the lateral defect

COMBINATION_PRODUCT

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

DIETARY_SUPPLEMENT

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

DRUG

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.

Sponsors & Collaborators

• Hasanuddin University

  lead OTHER

Principal Investigators

• abul Fauzi, DDS., MDS · Department of Oral and Maxillofacial Surgery

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

FACTORIAL

Eligibility

Min Age

18 Months

Max Age

78 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-06-01

Primary Completion

2025-06-01

Completion

2025-08-06

Countries

• Indonesia

Study Locations