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临床试验/NCT05351372
NCT05351372已完成不适用

Low-dose Cone-beam Computed Tomography for Assessment of Alveolar Clefts, a Randomized Controlled Trial in Image Quality

Karolinska Institutet2 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2016年5月31日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
72
试验地点
2
主要终点
Subjective image quality

研究概览

简要总结

Children born with an alveolar cleft receive bone grafts for improved function and aesthetics. The cleft area is radiologically examined before and post bone graft. Optimizing x-ray examination protocols is essential to protect these patients from possible delayed radiation injury later in life. This study investigates whether image quality of cone-beam computed tomography (CBCT) exposed with an ultra-low dose (ULD) protocol is comparable to the clinical default protocol, the standard dose (SD) protocol, in visualizing details of importance in bone grafting of alveolar clefts.

Methods In this randomized controlled study, 72 patients with uni- or bilateral alveolar clefts between 9-19 years (mean age 9.5) were randomized 1:1 with either a ULD or an SD CBCT examination protocol. The CBCT scans were conducted with Planmeca ProMax Mid with an 8x5cm field of view. Two experienced radiologists blindly evaluated the images and visibility of cortical bone border, trabecular bone, tooth anatomy, root development, periodontal space, and cleft width. The visibility was categorized as unacceptable, acceptable, or excellent.

详细描述

Radiographic imaging is an integral part of diagnostics, therapy planning and post-surgery assessment. Cone beam computed tomography (CBCT) was introduced in the late 90s and is now widely accepted. The technique utilizes a cone shaped X-ray beam to directly create a volumetric data, with predefined fields of view (FOV). CBCT provides 3D information with excellent spatial resolution, enabling assessment of anatomical variations and pathological changes in bone.

Cleft lip and palate disorder are among the most common birth defects, with the reported incidence in the Stockholm region of 1.7/1000 live births. The malformation can involve the lip, the alveolar process and the palate. When the alveolar process is involved CBCT can be indicated to assess the local anatomy prior to and after bone augmentation.

Minimizing the radiation dosage is especially important for children since the estimated risk for cancer formation or hereditable effects is approximately 3 times higher than for an adult aged 30.

Therefore the developments of low dose protocols within CBCT techniques are progressing rapidly. By applying more sensitive detector and a sophisticated image processing algorithm, the manufacturer Planmeca claimed that with Ultra Low Dose (ULD) protocol the effective patient dose may be reduced by up to 76%. A consequence of dramatically reduced exposure is the decreased signal-noise ratio, in other words reduced image quality, which results in increased diagnostic uncertainty of detailed structures. Since the accepted diagnostic image quality is highly associated with diagnostic tasks, clinical studies on evaluation new diagnostic feature are important.

HYPOTHESIS/RESEARCH QUESTION Will Promax 3D Mid CBCT with ULD normal dose protocol provide adequate information in order to assess necessary clinical questions in the region of the maxillary alveolar cleft compared to normal dose protocol?

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients with cleft involving the alveolar process undergoing treatment at Stockholm Craniofacial Centre
  • Reason for referral is CBCT examination in order to evaluate anatomy of the anterior maxilla prior to or after bone augmentation of the cleft
  • Patient/parent has given informed consent to participate in the study.

排除标准

  • No informed consent is given. Those patients will be examined according to standard clinical procedures.
  • Patients with a medical history of disorder/syndrome/chronic disease that will affect both the examination and the outcome.
  • No CBCT examination of the cleft area.

结局指标

主要结局

Subjective image quality

时间窗: 6 months

unacceptable=1, acceptable=2, excellent=3

次要结局

  • cortical border of bone adjacent to the cleft(6 months)
  • alveolar bone nearby the cleft(6 months)
  • periorontal space visibility(6 months)
  • Width of the cleft(6 months)
  • tooth anatomy of teeth adjacent to the cleft(6 months)
  • root development(6 months)

研究者

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

Tobias Regnstrand

Resident i Dentomaxillofacial radiology, PhD student

Karolinska Institutet

研究点 (2)

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