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临床试验/NCT04971642
NCT04971642已完成不适用

Ultrasound Imaging of Tooth-periodontium Complex Using an Innovative Intraoral Transducer

University of Alberta2 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2021年2月10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
64
试验地点
2
主要终点
Distance from alveolar bone crest to the cemento-enamel junction

研究概览

简要总结

Misaligned teeth are very common in the population and are commonly known as malocclusion. This happens when the upper teeth do not align properly with the lower teeth. It can lead to difficulty in jaw movement, chewing, speech, and gum disease. Correction of malocclusion requires orthodontic (braces) treatment. Currently, the imaging technique known as cone-beam computed tomography (CBCT) has been routinely used in orthodontic diagnosis and treatment planning for patients with malocclusion. Although CBCT provides better information than conventional dental X-rays, it typically delivers more harmful radiation to the patients. This is especially important as radiation from repeated X-ray imaging during dental monitoring visits can be cumulative.

Ultrasound is commonly used in medical imaging. The ultrasound method is non-invasive, cost-effective, and free of ionizing radiation. The application of ultrasound has been investigated in many fields in Dentistry. We plan to evaluate the ability of intra-oral ultrasound to see the bone and gingiva around the tooth for patients under orthodontic treatment. If ultrasound is found to be a reliable tool in imaging the tooth-gum complex, children and adolescents will benefit immensely from the decreased radiation risks and reduced cancer rate.

详细描述

Purpose:

The purpose of this study is to investigate a intraoral ultrasound to image the tooth-periodontium complex that is an alternative to ionizing radiation CBCT imaging.

Hypothesis:

Ultrasound imaging is a radiation-free alternative to image tooth-periodontium complex.

Justification:

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
10 Years 至 60 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Participants will be recruited to the Orthodontic Clinic-Oral Health Clinic at the Department of Dentistry - University of Alberta based on the following inclusion criteria:
  • Males or females in the age group of 10-60 years old
  • Individuals with permanent dentition
  • Dental malocclusion with mild to moderate crowding
  • Individuals undergoing CBCT imaging as part of Orthodontic diagnostic records Individuals in the age group of 10-60 years would have a full complement of permanent teeth erupted which will help standardize the research methodology to prevent an error in data acquisition, caused by the overlap of dental tissue in the mixed dentition period.

排除标准

  • Participants with missing permanent teeth, gingival recession (below CEJ), severe crowding, or a history of corrective orthodontics will be excluded. Any co-factors (previous orthodontic treatment) that might influence the ultrasound findings, will be excluded. Participants with unfavorable oral hygiene will be excluded due to the ambiguity associated with data acquisition in an inflamed periodontium. Also, participants presenting with craniofacial syndromes will be excluded due to the factors related to changes in craniofacial anatomy (maxilla-mandible anatomy)

结局指标

主要结局

Distance from alveolar bone crest to the cemento-enamel junction

时间窗: through study completion, an average of 1 year

It is the linear measurement distance in millimeters (mm) from the alveolar bone crest to the cemento-enamel junction anatomical structures observed in the Ultrasound image. It will be evaluated using an image software.

Cemento-enamel junction identification

时间窗: through study completion, an average of 1 year

The Identification of the cemento-enamel junction will be done by adding a point to this anatomical structure in the ultrasound image. It will be evaluated using an image software

Alveolar bone thickness

时间窗: through study completion, an average of 1 year

It is the linear measurement of the alveolar bone thickness at the alveolar bone crest level in millimeters (mm) observed in the Ultrasound image. It will be evaluated using an image software.

Gingival thickness

时间窗: through study completion, an average of 1 year

It is the linear measurement of the thickness of gingival tissue at the alveolar bone crest level in millimeters (mm) observed in the Ultrasound image. It will be evaluated using an image software

Distance from cemento-enamel junction to the gingival margin

时间窗: through study completion, an average of 1 year

It is the linear measurement distance in millimeters (mm) from the cemento-enamel junction to the gingival margin observed in the Ultrasound image. It will be evaluated through an image software.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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