Description of Pain in Pediatric Patients With Cleft Lip and Palate Undergoing Alveolar Grafting Using Two Surgical Strategies: Stem Cells and Autogenous Iliac Crest Bone (Pain Evaluation in Children Undergoing Alveolar Grafting: Stem Cells vs. Iliac Crest Bone)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Postoperative Pain Intensity
研究概览
简要总结
Study Objective The objective of this study was to evaluate and compare postoperative pain and hospital costs in pediatric patients with cleft lip and palate undergoing alveolar bone grafting surgery. The study compared a new tissue engineering approach against the traditional surgical technique. Background and Strategies To correct the bone defect in the upper jaw (alveolus), the standard treatment involves harvesting bone from the patient's hip (iliac crest). Although highly effective, this traditional method requires a second surgical site, which often leads to significant pain and complications at the donor site. To eliminate donor-site pain and morbidity, researchers evaluated an alternative approach using Stem Cells from Human Exfoliated Deciduous Teeth (SHED), which are naturally shed by children in this age group. These stem cells were combined with a collagen-hydroxyapatite scaffold (a supportive biomaterial sponge) to fill the bone defect, completely avoiding the need to harvest bone from the hip. Study Design A randomized controlled clinical trial was conducted with 20 pediatric patients aged 7 to 12 years with unilateral cleft lip and palate. Participants were randomly assigned into two equal groups: Group 1 (Control): Received the conventional autogenous bone graft harvested from the iliac crest. Group 2 (Experimental): Received the bioengineered graft combining SHED and the scaffold biomaterial. The researchers monitored the intensity and duration of pain in the Post-Anesthesia Care Unit (PACU) and the hospital ward. They also measured the consumption of simple analgesics and opioids (such as morphine and codeine) needed for pain relief, monitored postoperative complications, and performed an economic projection of medication expenditures.
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
- None
入排标准
- 年龄范围
- 7 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients aged between 7 and 12 years old.
- •Diagnosed with congenital unilateral cleft lip and palate.
- •Presenting with a maxillary alveolar cleft defect requiring secondary alveolar bone grafting (SABG) intervention.
- •Patient and legal guardians tracking dental development indicating the appropriate chronological/dental age for grafting (prior to canine eruption).
- •Written informed consent provided by parents or legal guardians, and assent provided by the pediatric participant.
排除标准
- •Patients with bilateral cleft lip and palate or complex syndromic craniofacial conditions.
- •Previous history of secondary alveolar bone grafting failure at the same anatomical site.
- •Systemic medical conditions that contraindicate general anesthesia or major oral surgery (e.g., uncontrolled bleeding disorders or severe systemic infections).
- •History of bone metabolism disorders or compromised immune systems that could interfere with bone healing or scaffold integration.
- •Inability or refusal of the family/patient to comply with follow-up appointments and postoperative clinical evaluations.
结局指标
主要结局
Postoperative Pain Intensity
时间窗: Up to 7 days post-surgery (specifically evaluated at 6 hours, 12 hours, 24 hours, 48 hours, and 7 days postoperatively).
Postoperative pain will be assessed using a validated visual analog scale (VAS) or faces pain scale appropriate for pediatric patients. Pain levels will be recorded at specific resting and moving intervals to compare the donor-site morbidity of the traditional iliac crest graft against the bioengineered scaffold.
次要结局
未报告次要终点