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

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07752849

Enrollment

Registered

2026-08-07

Start date

2026-08-01

Completion date

2028-12-01

Last updated

2026-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bilateral Cleft Palate, Cleft Palate, Complete Cleft Palat, Incompelet Cleft Palate, Unilateral Cleft Palate

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

Interventions

PROCEDUREStandard palatoplasty ( control)

Conventional palatoplasty performed without biological adjuncts

PROCEDUREPlatelet _ Rich Fibrin ( PRF)

Conventional palatoplasty augmented with autologous PRF matrix

COMBINATION_PRODUCTgentamicin_ loaded PRF

Conventional palatoplasty augmented with gentamicin \_ loaded PRF matrix

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

3 Months to 18 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Wound dehiscence rate	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.
palatal fistula formation rate	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
wound healing score	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.

Countries

Yemen

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 8, 2026