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临床试验/NCT06325163
NCT06325163已完成不适用

Accuracy of Artificial Intelligence Technology in Detecting Number of Root Canals in Human Mandibular First Molars Obturated and Indicated for Retreatment: Diagnostic Accuracy Experimental Study

Misr International University1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2023年1月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
35
试验地点
1
主要终点
Number of canals

研究概览

简要总结

evaluate the accuracy of new AI technology for detecting root canals in mandibular first molars retreatment cases in comparison to dentist clinical access cavity and CBCT imaging.

详细描述

evaluate the accuracy of new AI technology for detecting root canals in mandibular first molars retreatment cases in comparison to dentist clinical access cavity and CBCT imaging.

  1. CBCT exmanation stage: In this stage, CBCT scanning was done using Soredex Cranex 3D Dental Imaging System, FINLAND, with the following parameters ((XS FOV dimensions 61 x 41 mm (HxD)) (XS FOV High resolution 90 kV / 4 - 12.5 mA / 6.1 s)).

The samples will be randomized using randomization software (Microsoft Office Excel, USA) and will be assigned randomly to 2 endodontists who are unaware of the findings of stage 2. After interpreting and segmenting the CBCT scans in DICOM Format using OnDemand software (USA), the number of canals identified will be recorded on a pre-established information guide.

The samples are coded based on the patient's file number, and the codes were undisclosed so that the CBCT examiners could not identify the samples. All images were interpreted from the axial section in the analysis of the tomographic sections, the number of canals are identified by the corresponding radiolucent orifices, regardless of their location along the root 2. Clinical Stage: This is a clinical stage where the thirty-five patients, as predetermined by power analysis, will be randomly distributed upon 6 Practitioners using randomization software (Microsoft Office Excel). Practitioners will then proceed in access formation under dental operating microscope, (Leica M320D using magnification 16X, using fully integrated 4K camera).

Access will be done using TR13 diamond stone (Mani, Japan) to remove caries and restorations.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Sequential
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Males and females.
  • •Patients aged 18 to 40 years
  • •Repairable permanent first molars in the lower jaw, with a closed apex, which required non-surgical retreatment.
  • •One or more of the following signs and symptoms: Spontaneous pain, Pain on biting, Sinus tract, Radiolucency related to one or more roots.

排除标准

  • •Patients with lower first molars which are deemed non restorable, or have large perforations, external resorption, or vertical root fracture,
  • •Pregnant women
  • •Immunocompromised patients.

研究组 & 干预措施

A single arm consisting of 3 stages

Experimental

This study will include 3 stages:

  1. CBCT examination stage: In this stage, CBCT scanning will be done and examined by by 2 blinded endodontists and the number of canals identified will be recorded
  2. Clinical Stage: This is a clinical stage where patients will be randomly distributed upon 6 Practitioners using randomization software (Microsoft Office Excel). Practitioners will then proceed with the pretreatment procedures under dental operating microscope
  3. Artificial intelligence stage: The carrying out of this stage will be solely undertaken by the principal investigator. The CBCT images will be uploaded to convolutional neural network software (CNN) that uses a deep learning algorithm and CBCT segmentation. The software will then record the number of canals it found

干预措施: CBCT (Diagnostic Test)

A single arm consisting of 3 stages

Experimental

This study will include 3 stages:

  1. CBCT examination stage: In this stage, CBCT scanning will be done and examined by by 2 blinded endodontists and the number of canals identified will be recorded
  2. Clinical Stage: This is a clinical stage where patients will be randomly distributed upon 6 Practitioners using randomization software (Microsoft Office Excel). Practitioners will then proceed with the pretreatment procedures under dental operating microscope
  3. Artificial intelligence stage: The carrying out of this stage will be solely undertaken by the principal investigator. The CBCT images will be uploaded to convolutional neural network software (CNN) that uses a deep learning algorithm and CBCT segmentation. The software will then record the number of canals it found

干预措施: clinical examination under dental operating microscope (Diagnostic Test)

A single arm consisting of 3 stages

Experimental

This study will include 3 stages:

  1. CBCT examination stage: In this stage, CBCT scanning will be done and examined by by 2 blinded endodontists and the number of canals identified will be recorded
  2. Clinical Stage: This is a clinical stage where patients will be randomly distributed upon 6 Practitioners using randomization software (Microsoft Office Excel). Practitioners will then proceed with the pretreatment procedures under dental operating microscope
  3. Artificial intelligence stage: The carrying out of this stage will be solely undertaken by the principal investigator. The CBCT images will be uploaded to convolutional neural network software (CNN) that uses a deep learning algorithm and CBCT segmentation. The software will then record the number of canals it found

干预措施: canal detection AI software (diagnocat) (Diagnostic Test)

结局指标

主要结局

Number of canals

时间窗: The day of the procedure

the numbers of canals in mandibular molars indicated for retreatment will be measured using CBCT, clinical under dental operating microscope, and using AI software

次要结局

  • linear morphological variations in failed cases(Following the CBCT stage, an average of one week)

研究者

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

Albaraa Samir Abdelrwab Alkady

Principle investigator

Misr International University

研究点 (1)

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