Evaluation of the Diagnostic Accuracy of Cone-beam Computed Tomography (CBCT) Imaging Compared to the Two-dimensional (2D) Methods in the 3D Localization and Assessment of Maxillary Impacted Canines: A Surgical-exposure-based Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- The vertical position of the canine cusp
研究概览
简要总结
Seventeen patients diagnosed with the extraction-based treatment of impacted maxillary canines will be included in this study. Each patient will undergo conventional 2D radiography including panoramic, and lateral cephalometric, in addition to 3D imaging by cone beam computed tomography (CBCT) images.
A set of variables will be evaluated on 2D and 3D images by a panel of assessors and then these results will be compared with the gold standard which will be established based on surgical detection and direct visualization of the impacted canine.
详细描述
After taking the radiographic records, the impacted maxillary canines will be surgically exposed under local anesthesia where a full-thickness flap will be elevated from the buccal or palatal according to the initial radiographic diagnosis.
After cleaning the work yard to achieve good visibility, the pre-extraction parameters will be recorded which will be included labiopalatal position, mesiodistal position, and vertical position of the canine cusp, in addition to ankyloses of the impacted maxillary canine, proximity to the adjacent teeth, resorption of the adjacent incisors induced by the impacted maxillary canine, and bony coverage of the canine crown.
This will be followed by the extraction of the upper impacted canine and the recording of the post-extraction parameters, which will include the shape and the root apex development of the extracted canine. The pre- and post-extraction readings will be deemed the gold standard which will be compared to the 2D- and 3D-based assessments of the assessors.
Assessment sessions will be divided into two sessions with a one-week break in between. The first session will be devoted to the evaluation of the 2D image sets, while the second one will be to the evaluation of the 3D images.
Before beginning the assessment, the assessors will be subjected to a set of instructions and clarifications, including a set of graphs that help each assessor to accurately identify each variable, in addition to an oral explanation of some points so that the assessor will not fall into doubt when evaluating the radiographs.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 14 Years 至 27 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients from both gender (Male and female), Age range: 14-27 years.
- •Unilateral impaction of the maxillary canines requiring surgical extraction.
- •Non-syndromic patients without any pathology of the maxillofacial region (benign or malignant tumor, cleft lip or cleft palate, trauma)
- •Patients with a set of panoramic and lateral cephalometric images, in addition to CBCT radiograph (CBCT is indicated for treatment planning)
- •The time period between taking the radiological records and undergoing the surgical intervention does not exceed four weeks
排除标准
- •Patients who had a systemic disorder, cleft lip/cleft palate, craniofacial syndrome, traumatic injury, and congenital number anomaly.
- •Patients had previous orthodontic treatment.
结局指标
主要结局
The vertical position of the canine cusp
时间窗: The assessment will be performed after the surgical exposure of the impacted maxillary canine and "during surgery", i.e., after 10 minutes of the surgical exposure.
Assessment will be performed based on classification into three categories: 1-The cervical third, 2-The middle third, 3-The apical third
Labiopalatal position of the canine cusp
时间窗: The assessment will be performed after the surgical exposure of the impacted maxillary canine and "during surgery", i.e., after 10 minutes of the surgical exposure.
Assessment will be performed relative to the adjacent teeth based on classification into three categories: 1-Labial, 2-In situ, 3- Palatal
Resorption of the adjacent incisors induced by the impacted canine
时间窗: The assessment will be performed after the surgical exposure of the impacted maxillary canine and "during surgery", i.e., after 10 minutes of the surgical exposure.
Assessment will be performed based on the presence or absence of resorption in the adjacent teeth.
Diagnostic accuracy, sensitivity, and specificity
时间窗: The assessment will be performed after the extraction of the impacted maxillary canine, i.e., immediately following surgery
Values of the parameters were assessed using CBCT and 2D radiographs.
Mesiodistal position of the canine cusp
时间窗: The assessment will be performed after the surgical exposure of the impacted maxillary canine and "during surgery", i.e., after 10 minutes of the surgical exposure.
Assessment will be performed based on classification into five sectors: Section (B') From the distal margin of the central incisor to the midline of the Palatine. Section (B) Between the mesial and distal margins of the lateral incisor on the same side of the impaction. Section (A) Between the distal of the lateral incisor and the mesial of the 1st premolar on the same side of the impaction. Section (C) Between the mesial and distal margins of the 1st premolar on the same side of the impaction. Section (C') Between the distal of the 1st premolar and the distal of the 2nd premolar.
Ankylosis of the impacted maxillary canine
时间窗: The assessment will be performed after the surgical exposure of the impacted maxillary canine and "during surgery", i.e., after 10 minutes of the surgical exposure.
Assessment will be performed based on periodontal ligament distance (the canine root will be considered ankylosis if the periodontal ligament distance is equal to zero)
Proximity to the adjacent teeth
时间窗: The assessment will be performed after the surgical exposure of the impacted maxillary canine and "during surgery", i.e., after 10 minutes of the surgical exposure.
Assessment will be performed based on contact with the root of the adjacent incisor (the canine will be considered in contact when the space by 0 mm or less than 0.5 mm)
Root apex closure of the extracted canine
时间窗: The assessment will be performed after the extraction of the impacted maxillary canine, i.e., immediately following surgery
Assessment will be performed based on classification into two categories: 1-Open apex, 2- Closed apex
Bony coverage of the impacted maxillary canine
时间窗: The assessment will be performed after the surgical exposure of the impacted maxillary canine and "during surgery", i.e., after 10 minutes of the surgical exposure.
Assessment will be performed based on the classification of the bony coverage amount of the impacted canine crown into: 1- Completely covered with bone, 2- Partially covered with bone, 3- Uncovered
The shape of the extracted canine
时间窗: The assessment will be performed after the extraction of the impacted maxillary canine, i.e., immediately following surgery
Assessment will be performed based on the angle between the long axis of both the root and the crown and it will be classified into: 1-Straight (0°-10°), 2-Mildly curved (10°-30°), 3-Severe curved (\>30°)
次要结局
未报告次要终点