A Clinical Trial to Evaluate the Effectiveness and Safety of Dual Energy Cone-Beam Computed Tomography (DE-CBCT) Imaging for Quantitative Measurement of Jaw Bone Density
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Bone Density Assessment
研究概览
简要总结
Current radiologic imaging modalities used in dentistry provide information on the morphology of the hard tissues. Additional information on the density of bone has practical relevance, for example, in dental implant treatment planning, where local bone quality is a known strong predictor of successful implant osseointegration. The Dual-Energy Cone Beam Computed Tomography (DE-CBCT) device is designed to overcome limitations of traditional imaging and will provide assessment of jaw bone density in additional to morphological information.
This clinical trial will examine the application of DE-CBCT to assess jaw bone density and compare Hounsfield units (HU) values with multidetector CT, an established standard for assessing BD.
详细描述
This is a single center, open-label trial, designed to enroll 24 patients. Both, the researcher and the subject know the treatment the participant is receiving.
To evaluate the effectiveness and safety of DE-CBCT to evaluate jaw bone density and compare HU values with those of multidetector CT, an established standard for assessing BD.
The study is based on two visits (VISIT 1 and VISIT 2) • DAY 0 (enrollment): Subject is queried for inclusion/exclusion criteria and informed about the study. If he/she agrees to participate, inclusion/exclusion criteria and informed consent will be documented. An imaging stent, which bears radiopaque markers, will be also created for each patient.
• VISIT 1: Inclusion/exclusion criteria will be reconfirmed and the DE-CBCT imaging will be completed.
• VISIT 2 (no more than 30 days since the enrollment): Inclusion/exclusion criteria will be reconfirmed and MDCT imaging completed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who need x-ray imaging for dental treatment planning and/or diagnosis
- •Males or females aged older than 21
- •Can follow instructions to be positioned into the CT scanner
- •Can remain physically immobile during the CT scan acquisition
- •Voluntarily sign and date the informed consent
排除标准
- •Patients who are unable to comprehend the risks of the study to provide informed consent
- •Extensive dental restorations, maxillofacial prosthesis, or orthopedic hardware that likely may cause artifacts and degrade quality, as determined by the study radiologists
研究组 & 干预措施
CT scan
CT scan (MDCT, standard of care) and DE-CBCT (Investigational)
干预措施: Dual-energy computed tomography scan (Device)
结局指标
主要结局
Bone Density Assessment
时间窗: 30 days
Bone density (g/cc) in a region of interest measured by the OnDemand software
次要结局
未报告次要终点
研究者
Sanjay Mallya, BDS, MDS, PhD
Associate Professor
University of California, Los Angeles