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临床试验/NCT04987190
NCT04987190已完成不适用

Progressive Comparison of Density Assessment of Alveolar Bone Graft in Patients With Unilateral and Bilateral Cleft

Chang Gung Memorial Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年1月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
mean calibrated bone mineral density (BMD/pogonion density, BMDc)

研究概览

简要总结

The patients with unilateral and bilateral cleft lip and palate received alveolar bone graft surgery. Two time points of cone beam CT were taken for all the patients: post-operative 6 months, and post-operative 2 years. All the CT images were reviewed for the analysis of grafted bone density.

详细描述

Patient Information and Data Collection Patients who had nonsyndromic unilateral or bilateral cleft lip and alveolus with or without cleft palate and received ABG at our center between 2016 and 2018 were enrolled. All patients underwent at least 2 CBCT scans after operation. Postoperative image acquisition was performed at two time points, namely 6 months (T1) and 2 years (T2) after ABG. The ABG procedures for all patients were performed by the same senior surgeon per the protocol of our center, which comprises an iliac cancellous bone graft and the sealing of the Scarpa fascia to the defect before the bone graft is packed.2,12 Patient who had syndromic cleft alveolus, who underwent two-stage ABG (performed for bilateral cases), or who exhibited failed grafted tissue were excluded. In total, 40 patients were enrolled in the present study. The demographic and clinical variables for ABG were retrospectively collected through a review of medical charts. All CBCT images were obtained using an i-CAT CBCT scanner (Imaging Sciences International, Hatfield, PA, USA); the parameters for the images are as follows: 120 kVp, voxel size of 0.4 × 0.4 × 0.4 mm3, 40-s scan time, and 22 × 16-cm field of view.

BMD Measurement The Picture Archiving and Communication System (PACS) was applied for image analysis. In addition, areas of interest were checked in the axial view slice by slice to locate the grafted tissue. Three methods (A, B, and C), which differed by the size of the selected area, were designed to measure Hounsfield units (HU). For all methods, we first identified the most superior and inferior planes transecting the grafted tissue. Subsequently, the middle plane of the grafted tissue was identified. For the selected plane, the distance between two teeth had to be larger than 2.5 mm in diameter; this was required for all three methods. On each plane, the selected circular area is defined as being located at the midpoint of the line between the centers of the two adjacent teeth. The HU of the selected area could be obtained using PACS.

For Method A, the circular zone located 1 mm from the adjacent teeth was selected. For Method B, the largest circular zone that exactly transected the two adjacent teeth or was tangent to the surrounding cortical bone was selected. For Method C, a circle was drawn with a diameter of 2 mm. Furthermore, an area of 2 × 0.5 mm2 in the pogonion was selected to obtain its HU at T1 and T2; this was the reference for calibration (Figure, Supplemental Digital Content 1). HU was the reference for BMD13 and represented the average density of the three planes. Calibrated BMD (BMDc, %) was defined using the following formula:

〖BMD〗c (%)=〖HU〗(selected zone)/〖HU〗_pogonion ×100.

Density enhancement rate (%) was calculated using the following formula:

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
8 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patients who had nonsyndromic unilateral or bilateral cleft lip and alveolus with or without cleft palate
  • Patients received alveolar bone graft at their 9 years of age
  • Patients received twice CBCT after the surgery

排除标准

  • Patient had syndromic cleft alveolus
  • Patient underwent two-stage ABG (performed for bilateral cases)
  • Patient exhibited failed grafted tissue

结局指标

主要结局

mean calibrated bone mineral density (BMD/pogonion density, BMDc)

时间窗: 2nd BMD at post-operative 2 years

BMD presented from CBCT

次要结局

未报告次要终点

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Pangyunchou

Craniofacial Research Center

Chang Gung Memorial Hospital

研究点 (1)

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