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

NCT07752849 | Recruiting

• 1 other identifier: CLEFT_PRF_2026
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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

Bilateral Cleft Palate; Complete Cleft Palat; Incompelet Cleft Palate; Cleft Palate; Unilateral Cleft Palate

Outcome Measures

Primary Outcomes (3)

• Wound dehiscence rate

  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.

  At 7 day , 14 day , and 30 day postoperatively

• palatal fistula formation rate

  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

  at 3 month postoperatively

• wound healing score

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

  At 7 day , 14 day , and 30 day postoperatively

Study Arms (3)

Standard palatoplasty ( control )

ACTIVE COMPARATOR

Conventional palatoplasty without biological adjuncts

Procedure: Standard palatoplasty ( control)

Standard palatoplasty + PRF

EXPERIMENTAL

Conventional palatoplasty augmented PRF

Procedure: Platelet _ Rich Fibrin ( PRF)

Standard palatoplasty +Gentamicin- PRF

EXPERIMENTAL

Conventional palatoplasty augmented with gentamicine - loaded PRF

Combination Product: gentamicin_ loaded PRF

Interventions

Standard palatoplasty ( control) PROCEDURE

Conventional palatoplasty performed without biological adjuncts

Standard palatoplasty ( control )

Platelet _ Rich Fibrin ( PRF) PROCEDURE

Conventional palatoplasty augmented with autologous PRF matrix

Standard palatoplasty + PRF

gentamicin_ loaded PRF COMBINATION_PRODUCT

Conventional palatoplasty augmented with gentamicin \_ loaded PRF matrix

Standard palatoplasty +Gentamicin- PRF

Eligibility Criteria

• Age: 3 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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.

Sponsors & Collaborators

• Al-Thawra Modern General Hospital: lead

Study Sites (1)

Al_ Thawra General Hospital Authority

Sanaa, Yemen

RECRUITING

MeSH Terms

Conditions

Cleft Palate

Condition Hierarchy (Ancestors)

Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic Diseases; Mouth Abnormalities; Mouth Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator / Master's Traine in oral and maxillofacial Surgery

Study Record Dates

• First Submitted: August 3, 2026
• First Posted: August 7, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: August 7, 2026

Record last verified: 2026-08

Locations

YE (1)