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临床试验/NCT02859025
NCT02859025已完成1 期

Lateral Ramus Cortical Bone Plate in Alveolar Cleft Osteoplasty: Concomitant Use of Buccal Fat Pad Derived Cells and Autogenous Bone in a Preliminary Study

Shahid Beheshti University of Medical Sciences2 个研究点 分布在 2 个国家目标入组 10 人开始时间: 2015年1月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
10
试验地点
2
主要终点
change in bone volume

研究概览

简要总结

Our aim was to combine regenerative techniques with bone grafting in human models to increase predictability and survival of reconstructed tissue. The MSCs in this study were derived from an intra oral fat source (BFP) and were cultured over natural bovine bone mineral granules and delivered within the lateral ramus cortical bone plate (LRCP)to treat human alveolar cleft defects.

详细描述

Patients enrolled in the present study were suffering from alveolar cleft and had previously received orthodontic treatment and only required secondary alveolar grafting. The buccal fat pad derived stem cells (BFPSCs) were harvested from buccal fat pad tissues of the patients. Patients were divided into 3 groups. Group A , the control group, was treated with anterior iliac crest (AIC) spongy bone to fill defects, followed by coverage with collagen membrane. Group B was treated with lateral ramus cortical bone cage (LRCP), used to create a protected healing space by fixing it to adjacent walls of the cleft defect. Group C was treated with (AIC) as in Group 1, but BFP-derived MSCs cultured over NBBM were put over the spongy bone and covered with a collagen membrane.Passage 3 BFPSCs were loaded on the implants ( Cerabone (Botiss, Berlin, Germany) a natural bovine bone mineral (NBBM); a granular biomaterial with a 200- to 850-µm particle size) 3 days prior to transplantation.Cone beam computed tomography (CBCT) was obtained after 6 months.

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

性别
All
接受健康志愿者

入选标准

  • Unilateral congenital cleft lip and palate
  • Previous presurgical orthodontic treatment

排除标准

  • History of malignancy
  • History of radiation
  • History of chemotherapy
  • Pregnancy
  • Systemic diseases contradicting dental and surgical treatments
  • Conditions or drugs affecting bone remodeling or bone metabolism and connective tissue
  • Allergy to collagen

结局指标

主要结局

change in bone volume

时间窗: before the surgery and 6 months after the surgery

1-mm coronal sections of the treated region were taken before and after surgery, and new bone formation was assessed by CBCT.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Arash Khojasteh

Associate professor

Shahid Beheshti University of Medical Sciences

研究点 (2)

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