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

NCT07752849 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-08-07

No results posted yet for this study

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

Conditions

  • Cleft Palate
  • Unilateral Cleft Palate
  • Bilateral Cleft Palate
  • Complete Cleft Palat
  • Incompelet Cleft Palate

Interventions

PROCEDURE

Platelet _ Rich Fibrin ( PRF)

Conventional palatoplasty augmented with autologous PRF matrix

COMBINATION_PRODUCT

gentamicin_ loaded PRF

Conventional palatoplasty augmented with gentamicin \_ loaded PRF matrix

PROCEDURE

Standard palatoplasty ( control)

Conventional palatoplasty performed without biological adjuncts

Sponsors & Collaborators

  • Al-Thawra Modern General Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
3 Months
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2028-12-31
Completion
2028-12-31

Countries

  • Yemen

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07752849 on ClinicalTrials.gov