Cost Effectiveness in Alveolar Bone Grafting in Patients With Cleft Lip and Palate: A Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Health system costs per successful bone graft.
研究概览
简要总结
The purpose of this trial is to evaluate if the use of Bone Morphogenic Protein(BMP)/Demineralized Bone Matrix (DBM) versus the use of autologous Iliac Crest Bone Graft (ICBG) will result in an increase in total cost effectiveness for patients undergoing alveolar bone graft (ABG) for Cleft Lip and Palate (CLP) and to see if patients who are treated with DBM/BMP will have reduced post-operative pain scores,reduced operative times,and similar rates of bone healing compared to conventional ICBG.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
盲法说明
To prevent surgeon bias in operative time and therefore cost, randomization assignments will be concealed at the beginning of surgery. The surgeon will start with closure of the oronasal fistula first. Once that is completed, the envelope will be opened and reveal the type of bone graft selected. The surgeon will then either harvest the additional ICBG or open the packets for the DBM/BMP and pack the selected type of bone into the alveolus.
Outcomes assessor including orthodontist and clinical research evaluator will be blinded to treatment arms.
入排标准
- 年龄范围
- 6 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with CLP(unilateral or bilateral)
- •Radiographically evident open bone defect of the alveolus
- •Dentition evaluated by orthodontist and cleared for ABG surgery
排除标准
- •Patients without CLP
- •Previous failed repair of alveolar cleft
- •Patients who have previously undergone successful ABG
- •Patients without an alveolar defect
- •Patients whose parents refuse to consent to randomization
- •Patients who have a syndromic CLP
研究组 & 干预措施
Intervention group (DBM/BMP)
Patient undergoes Alveolar bone graft with DBM/BMP
干预措施: Intervention group (DBM/BMP) (Drug)
Control group(autologous ICBG)
Patient undergoes Alveolar Bone Graft with Iliac Crest Bone graft.
干预措施: Control group(autologous ICBG) (Drug)
结局指标
主要结局
Health system costs per successful bone graft.
时间窗: One year post graft
Health system costs will be reported as the total sum of all costs including incremental surgeon time costs, hospital costs, revision costs, and additional outpatient costs for clinic or ER visits. Bone graft success be defined as no need for a repeat bone graft, as well as by assessment by blinded orthodontist evaluations of the Post op Cone beam computed tomography(CBCT).
次要结局
- Anesthesia Time(1 day)
- Operative Time(1 day)
- Graft Success(3 months post graft)
- Infection(3 months post graft)
- Fistula Recurrence(3 months post graft)
- Rate of Revision ABG(3 months post graft)
- Post Operative Pain Scores(1 week post operatively)
- Pain Medication Usage(1 week post operatively)
- Post Op Fever(3 months)
- Drainage from Fistula(3 months)
- Post Op ER Visits(3 months.)
研究者
Matthew Greives
Assistant Professor
The University of Texas Health Science Center, Houston