Clinical Evaluation and Patient Experience of a Stationary Intraoral Tomosynthesis (s-IOT) Unit Using a Carbon Nanotube X-ray Source Array
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- ROC Using the Area Under the Curve (AUC)
研究概览
简要总结
A comparison of caries detection rates between conventional intraoral bitewing radiography and a stationary intraoral digital tomosynthesis (s-IOT) using a carbon nanotube X-ray source array. The secondary objective is to assess participants experience with the s-IOT device.
详细描述
The primary purpose of this study is to compare caries detection rates between conventional intraoral bitewing radiography and a stationary intraoral digital tomosynthesis (s-IOT) using a carbon nanotube X-ray source array. Patient experience with the s-IOT device will be assess using a short questionnaire.
Fifty adult patients who have been referred to the Section of Oral and Maxillofacial Radiology (OMR) at the University of North Carolina (UNC) School of Dentistry (SOD) for horizontal bitewing (BW) radiographs or a Full Mouth Series (FMX) with horizontal bitewing radiographs will be recruited for the study.
Participants will receive an experimental s-IOT bitewing radiograph on each side of their mouth and a visual exam to look for caries. Experienced observers will assess the presence or absence of caries using the two imaging modalities. The results of their analysis will be evaluated to determine statistical difference. Participants completed questionnaires will be tabulated and the data will be analyzed using descriptive statistics.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years and older
- •Scheduled for horizontal BW or Full (FMX) with horizontal BWs
- •Patients who have in the right and left maxilla and mandible at least a canine and two posterior teeth that are in contact
- •At least one proximal caries lesion in a surface of a posterior tooth (premolar or molar) that is in contact with another tooth. Lesion depth can be incipient (outer half enamel), moderate (inner half enamel) or advanced (outer half dentin) as determined by conventional BW radiography.
- •At least one non-carious proximal surface of a posterior tooth (premolar or molar) that is in contact with another tooth.
- •Patients should be able to provide informed consent
排除标准
- •Institutionalized subject (prisoners, nursing home, etc.) (identified by medical record)
- •Critically ill or mentally unstable patients (identified by medical record)
- •Patients with no radiographic caries of the posterior teeth as determined by conventional BW radiographs
- •Patients with only severe caries lesions as determined by conventional BW radiographs
结局指标
主要结局
ROC Using the Area Under the Curve (AUC)
时间窗: Within 7 months of last participants imaging
This prospective study is to compare the diagnostic performance (accuracy) of a stationary intraoral tomosynthesis device using a Carbon Nanotube X-ray source array and a conventional intraoral X-ray device in the diagnosis of interproximal caries. receiver operating characteristic (ROC) analysis will be used to compare the areas under the curve (AUC).
Proportion of Healthy Tooth Surfaces
时间窗: Within 7 months of last participants imaging
Specificity reflects the ability of the system to correctly identify healthy tooth surfaces expressed as a proportion.
Proportion of Carious Tooth Surfaces
时间窗: Within 7 months of last participants imaging
Sensitivity reflects the ability of the system to correctly identify carious tooth surfaces expressed as a proportion.
次要结局
- Number of Participants With a Positive Experience(During a single 2-hour visit)
- Overall Investigator Confidence Survey(During a single 2-hour visit)