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NCT Number: NCT07752849

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

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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Key information

Conditions

Cleft Palate Bilateral Cleft Palate Complete Cleft Palat Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities Incompelet Cleft Palate Jaw Abnormalities Jaw Diseases Maxillofacial Abnormalities Mouth Abnormalities Mouth Diseases Musculoskeletal Abnormalities Musculoskeletal Diseases Stomatognathic Diseases Stomatognathic System Abnormalities Unilateral Cleft Palate

Age range

3 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Al_ Thawra General Hospital Authority

Sanaa, Yemen

Location status: Recruiting

Location contact

SUMYAH Mohammed Abdulwasea, MSc Trainee

CONTACT

[email protected]

+967730129165

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Standard palatoplasty ( control)

Procedure

Conventional palatoplasty performed without biological adjuncts

Platelet _ Rich Fibrin ( PRF)

Procedure

Conventional palatoplasty augmented with autologous PRF matrix

gentamicin_ loaded PRF

Combination Product

Conventional palatoplasty augmented with gentamicin _ loaded PRF matrix

Primary outcomes

  1. Wound dehiscence rate

    Time frame: At 7 day , 14 day , and 30 day postoperatively

    Assessed using Wound Dehiscence Severity Score (WDSS) ranging from 0 (Intact, complete structural integrity) to 3 (Complete failure, full-thickness structural separation requiring surgical revision). Higher scores indicate worse outcomes.

  2. palatal fistula formation rate

    Time frame: at 3 month postoperatively

    Assessed using Oronasal Fistula Severity & Dimension Score (OFSDS) ranging from 0 (Absent, intact palate) to 3 (Major fistula, anatomical defect > 5 mm requiring secondary surgical closure). Higher scores indicate worse outcomes

  3. wound healing score

    Time frame: At 7 day , 14 day , and 30 day postoperatively

    Assessed using Modified Primary Healing Scale (MPHS) ranging from 1 (Optimal Healing) to 4 (Severe Failure). Higher scores indicate worse outcomes.

Sponsors and collaborators

Lead sponsor

Al-Thawra Modern General Hospital

Other

Registry information

Official study title

A Prospective Randomized Clinical Trial Comparing Standard Palatoplasty Alone, Standard Palatoplasty With Platelet-Rich Fibrin (PRF), and Standard Palatoplasty With Gentamicin-Loaded PRF for Unilateral and Bilateral Complete and Incomplete Cleft Palate Cases

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 7, 2026
Registry last updated
Aug 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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