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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Wound dehiscence rate
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Standard palatoplasty ( control )
Conventional palatoplasty without biological adjuncts
干预措施: Standard palatoplasty ( control) (Procedure)
Standard palatoplasty + PRF
Conventional palatoplasty augmented PRF
干预措施: Platelet _ Rich Fibrin ( PRF) (Procedure)
Standard palatoplasty +Gentamicin- PRF
Conventional palatoplasty augmented with gentamicine - loaded PRF
干预措施: gentamicin_ loaded PRF (Combination Product)
结局指标
主要结局
Wound dehiscence rate
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点
研究者
Sumyah Mohammed Abdulwasea Saeed
Principal Investigator / Master's Traine in oral and maxillofacial Surgery
Al-Thawra Modern General Hospital