Palatoplasty Techniques Using PRF and Gentamicin-Loaded PRF in Cleft Palate
A Prospective Randomized Clinical Trial Comparing Standard Palatoplasty Alone, Standard Palatoplasty With Platelet-Rich Fibrin (PRF), and Standard Palatoplasty With Gentamicin-Loaded PRF for Unilateral and Bilateral Complete and Incomplete Cleft Palate Cases
Al-Thawra Modern General Hospital
90 participants
Aug 1, 2026
INTERVENTIONAL
Conditions
Summary
This prospective, randomized controlled trial evaluates the clinical efficacy of autologous Platelet-Rich Fibrin (PRF) and Gentamicin-Loaded PRF as regenerative and antimicrobial biological adjuncts in primary palatoplasty. A total of 90 pediatric and adolescent patients with unilateral and bilateral complete and incomplete cleft palates will be assigned across three parallel treatment arms: standard palatoplasty alone (control), palatoplasty augmented with standard PRF, and palatoplasty augmented with gentamicin-loaded PRF. The primary objective is to compare quantitative primary mucosal healing scores, wound dehiscence rates, and the incidence of postoperative oronasal fistula formation to determine whether local gentamicin-PRF delivery significantly improves soft-tissue healing and reduces surgical breakdown
Eligibility
Plain Language Summary
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Interventions
Conventional palatoplasty performed without biological adjuncts
Conventional palatoplasty augmented with autologous PRF matrix
Conventional palatoplasty augmented with gentamicin \_ loaded PRF matrix
Locations(1)
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NCT07752849