Clinical Trial

Palatoplasty Techniques Using PRF and Gentamicin-Loaded PRF in Cleft Palate

Recruiting
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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
Trial Details
NCT Number NCT07752849
Lead Sponsor Al-Thawra Modern General Hospital
Conditions Cleft Palate, Unilateral Cleft Palate, Bilateral Cleft Palate, Complete Cleft Palat, Incompelet Cleft Palate
Enrollment 90 participants
Start Date 2026-08-01
Primary Completion 2028-12 (estimated)
Study Completion 2028-12 (estimated)
Updated on ClinicalTrials.gov 2026-08-07