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临床试验/NCT05002920
NCT05002920已完成不适用

Correlation Between Body Mass Index and Progressive Bone Mineral Density in Cleft Patients After Secondary Alveolar Bone Grafting

Chang Gung Memorial Hospital1 个研究点 分布在 1 个国家目标入组 39 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
39
试验地点
1
主要终点
bone mineral density

研究概览

简要总结

The cleft patients received alveolar bone graft(ABG) for alveolar defect. Body mass index (BMI) was measured for each patients when receiving ABG. Bone mineral density was measured by Cone-Beam CT at two time-points: post-ABG six months, and post-ABG two years. The study was to analyze the correlation between BMI and post-operative bone mineral density.

详细描述

Although childhood obesity is a growing issue, the association between BMI and the progressive bone mineral density (BMD) in grafted tissue after secondar alveolar grafting (ABG) remains little reviewed. This study compared the correlation between BMI and the progressive BMD after ABG procedure. Thirty-nine patients with unilateral or bilateral clefts were enrolled. ABG was performed at mixed-dentition age. Patient were classified into underweight, normal weight, and overweight or obese based on age- and sex-adjusted BMI. BMD was expressed in Hounsfield unit (HU) on cone-beam computed tomography (CBCT), which was obtained at 6 months (T1) and 2 years (T2) postoperatively. Calibrated BMD (HUgrafted tissue/HUpogonion¬, BMDc) was used for further analysis.

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

  • nonsyndromic unilateral or bilateral cleft lip and alveolus with or without palate patients
  • received secondary ABG at Chang Gung Craniofacial Center
  • received team managements based on our current treatment protocol for cleft lip and palate

排除标准

  • syndromic cleft
  • patients with failed grafted tissue

结局指标

主要结局

bone mineral density

时间窗: post-ABG two years

measuring the bone density from cone beam CT

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

Assistant Professor

Chang Gung Memorial Hospital

研究点 (1)

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