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

Recruiting now · Not applicable

Conditions studied: Cleft Palate, Unilateral Cleft Palate, Bilateral Cleft Palate, Complete Cleft Palat, Incompelet Cleft Palate

In brief

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

Key facts

Study ID

NCT07752849

Run by

Al-Thawra Modern General Hospital

People needed

90

Starts

2026-08-01

Expected to finish

2028-12-01

Last updated by the study team

2026-08-07

Who can join

Age: 0 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Al_ Thawra General Hospital Authority — Sanaa, Yemen (enrolling)

Full record on ClinicalTrials.gov

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