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
Patients presenting with non-syndromic complete or incomplete unilateral or bilateral cleft palate.
Scheduled for primary palatoplasty.
Age within the specified study range.
Informed consent signed by parents or legal guardians.
Patients with associated syndromic clefts or major congenital anomalies.
Previous history of palatal surgery or failed prior palatoplasty.
Bleeding disorders, active systemic infections, or contraindications to surgery or general anesthesia.
Patients lost to follow-up or incomplete records.