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

RecruitingNAAges 3 Months - 18 YearsAllAl-Thawra Modern General Hospital
NCT07752849 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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.
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What it tests

  • Standard palatoplasty ( control)
  • Platelet _ Rich Fibrin ( PRF)
  • gentamicin_ loaded PRF
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Where

1 site
Al_ Thawra General Hospital Authority
Sanaa, Yemen
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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