Overview

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

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.