Evaluating Salivary α - Amylase Levels Following Trigona Sp Honey Application To Post Palatoplasty Patients: A Pilot Randomized Clinical Study
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.
Přehled studie
Postavení
Intervence / Léčba
- Kombinovaný produkt: Trigona sp honey with the buccal fat pad technique
- Doplněk stravy: Trigona sp. honey dressing without the buccal fat pad technique
- Kombinovaný produkt: framicetyn sulfate dressing with the buccal fat pad technique
- Lék: framicetyn sulfate dressing without the buccal fat pad technique
Detailní popis
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:
- Trigona sp. honey dressing with buccal fat pad technique
- Trigona sp. honey dressing without buccal fat pad technique
- Framycetin sulfate dressing with buccal fat pad technique
- 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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
South Sulawesi
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Makassar, South Sulawesi, Indonésie, 90245
- Hasanuddin University Dental Hospital
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
Přijímá zdravé dobrovolníky
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Faktorové přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Trigona sp. honey dressing with the buccal fat pad technique
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
|
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
Ostatní jména:
|
|
Experimentální: Trigona sp. honey dressing without the buccal fat pad technique
Participants in this arm underwent palatoplasty using the two-flap push-back technique under general anesthesia followed by trigona sp honey dressing
|
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
Ostatní jména:
|
|
Experimentální: framicetyn sulfate dressing with the buccal fat pad technique
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
|
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
Ostatní jména:
|
|
Experimentální: framicetyn sulfate dressing without the buccal fat pad technique
Participants in this arm underwent palatoplasty using the two-flap push-back technique under general anesthesia followed by framicetyn sulfate dressing
|
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.
Ostatní jména:
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in Salivary α-Amylase Levels Following Palatoplasty
Časové okno: Preoperative baseline, postoperative day 4, and postoperative day 7
|
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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: abul Fauzi, DDS., MDS, Department of Oral and Maxillofacial Surgery
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Nemoci pohybového aparátu
- Nemoci úst
- Stomatognátní onemocnění
- Onemocnění čelistí
- Abnormality čelistí
- Maxilofaciální abnormality
- Kraniofaciální abnormality
- Muskuloskeletální abnormality
- Abnormality stomatognátního systému
- Vrozené vady
- Abnormality v ústech
- Vrozené, dědičné a neonatální nemoci a abnormality
- Rozštěp patra
Další identifikační čísla studie
- No. 074/KEPK FKG-RSGMP UH/EA/I
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Informace o lécích a zařízeních, studijní dokumenty
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