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

NCT07610993 | Completed

• 1 other identifier: No. 074/KEPK FKG-RSGMP UH/EA/I
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

buccal fat pad; cleft palate; framycetin sulfate; honey; salivary alpha-amylase

Outcome Measures

Primary Outcomes (1)

• Change in Salivary α-Amylase Levels Following Palatoplasty

  Salivary α-amylase levels will be measured using ELISA analysis to evaluate postoperative inflammatory response and wound healing following the application of (1) Trigona sp honey dressing with the buccal fat pad technique, (2) Trigona sp honey dressing without the buccal fat pad technique, (3) framycetin sulfate dressing with the buccal fat pad technique, (4) framycetin sulfate dressing with the buccal fat pad technique in post-palatoplasty patients.

  Preoperative baseline, postoperative day 4, and postoperative day 7

Study Arms (4)

Trigona sp. honey dressing with the buccal fat pad technique

EXPERIMENTAL

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

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

Trigona sp. honey dressing without the buccal fat pad technique

EXPERIMENTAL

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

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

framicetyn sulfate dressing with the buccal fat pad technique

EXPERIMENTAL

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

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

framicetyn sulfate dressing without the buccal fat pad technique

EXPERIMENTAL

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

Drug: framicetyn sulfate dressing without the buccal fat pad technique

Interventions

Trigona sp honey with the buccal fat pad technique COMBINATION_PRODUCT

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

Also known as: stingless bee

Trigona sp. honey dressing with the buccal fat pad technique

framicetyn sulfate dressing with the buccal fat pad technique COMBINATION_PRODUCT

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

Also known as: sufratulle

framicetyn sulfate dressing with the buccal fat pad technique

Trigona sp. honey dressing without the buccal fat pad technique DIETARY_SUPPLEMENT

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

Also known as: stingless bee

Trigona sp. honey dressing without the buccal fat pad technique

framicetyn sulfate dressing without the buccal fat pad technique DRUG

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.

Also known as: sufratulle

framicetyn sulfate dressing without the buccal fat pad technique

Eligibility Criteria

• Age: 18 Months - 78 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• a history of systemic disease,
• allergies to honey ingredients,
• failure to follow the examination and evaluation until the end according to the research procedure

Sponsors & Collaborators

• Hasanuddin University: lead

Study Sites (1)

Hasanuddin University Dental Hospital

Makassar, South Sulawesi, 90245, Indonesia

Location

MeSH Terms

Conditions

Cleft Palate

Condition Hierarchy (Ancestors)

Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic Diseases; Mouth Abnormalities; Mouth Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• abul Fauzi, DDS., MDS

  Department of Oral and Maxillofacial Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Not applicable. No masking was applied in this study
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Director / Sub-Investigator

Model Details: Four arms factorials pilot randomized clinical study comparing -amylase level as a marker of wound healing following Trigona sp. honey and framycetin sulfate with or without buccal fat pad in post-palataloplasty patients

Study Record Dates

• First Submitted: May 14, 2026
• First Posted: May 28, 2026
• Study Start: June 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: August 6, 2025
• Last Updated: May 28, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)