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临床试验/NCT07008014
NCT07008014尚未招募不适用

What is the Scope for Low Field MRI to Replace Cone Beam Computed Tomography in Dentistry?

King's College London0 个研究点目标入组 20 人开始时间: 2025年7月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
20
主要终点
Percentage of patients whose diagnosis/care changed as a result of the additional dental MRI imaging compared to the total number of patients imaged using conventional radiography.

研究概览

简要总结

Magnetic Resonance Imaging (MRI) has is a useful diagnostic tool that offers advantages over conventional radiography techniques. Unlike traditional X-ray or computed tomography (CT) scans, MRI utilizes a magnetic field and radio waves to generate detailed and high-resolution images of the body's internal structures. This non-invasive imaging modality allows the clinician to better see soft tissues in 3D without the use of ionising radiation. Furthermore, MRI enables the detection and characterization of a wide range of pathologies which can lead to improved diagnostic capabilities and better patient outcomes.

To date, the use of MRI in dentistry has been limited as dentistry imaging focuses predominantly on hard tissues (teeth and bones) in addition to the higher cost and accessibility issues with MRI machines.

However, recent developments have led to the development of a dental-specific coil for use with a low field strength (0.55 Tesla) MRI scanner. This has resulted in high diagnostic quality soft and hard tissue images and reduced imaging time. As this imaging modality has rarely been used before in dentistry, the aim of this study is to investigate its use for dental imaging, refining parameters and assessing the diagnostic quality of dental scans taken using MRI and the specific dental coil.

详细描述

The overall aim of this feasibility project is to optimise MRI parameters for dental use (i.e., dental-dedicated MRI) and assess the diagnostic quality of dental scans taken using MRI.

The objectives are to assess if MRI imaging has altered the diagnosis, retrospectively analyse the numbers of patients which can be diagnosed effectively using this radiation free imaging modality and document health resource use to inform a full health technology assessment trial.

The primary objective is to assess the feasibility of providing MRI scanning to dental patients and the resultant benefit. As such, the investigators will examine the percentage of patients whose diagnosis was altered as a result of additional MRI scanning.

The secondary objectives are to assess:

  1. The percentage of patients who would have been able to complete their diagnosis with an MRI scan alone
  2. Percentage of eligible patients who agreed to have an MRI scan
  3. Percentage of patients who completed the MRI scan
  4. Clinician rated diagnostic acceptability
  5. Patient acceptability of the imaging modality (as determined by VAS scale)
  6. Documentation of Health resource use including intervention costs

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
3 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 3 or over with suspected orofacial pathology involving a soft tissue component or healthy volunteers
  • The patient is willing to undergo an MRI investigation
  • Patient or their carer/guardian is able to provide informed consent to the study

排除标准

  • Patient or their carer is unable to show Gillick competency for consent.
  • The patient has pronounced claustrophobia.
  • The patient has a pacemaker or implanted defibrillator.
  • The patient has history of metal shrapnel injuries to the eyes or MRI incompatible metallic inclusions or implants/ large tattoos.
  • The patient has non-removable piercings.
  • Pregnant patients, or patients who suspect they could be pregnant
  • The patient has participated in other research studies within the previous 30 days.

结局指标

主要结局

Percentage of patients whose diagnosis/care changed as a result of the additional dental MRI imaging compared to the total number of patients imaged using conventional radiography.

时间窗: 4 weeks

The treatment plan that was given before the MRI scan will be documented. Following review of the MRI by the overseeing consultant, any changes to the treatment plan will be documented. The number of patients whose treatment plan was altered as a result of the scan will be divided by the number of those who received a scan to get a percentage.

To assess diagnostic quality of the image

时间窗: 6 months

This is a feasibility trial and a new imaging modality for dentistry. Working with MR physicists we will assess image quality and report on areas for improvement

次要结局

  • Percentage of patients whereby the diagnosis could have been obtained using dental-dedicated MRI alone(4 weeks)
  • Time spent undergoing scan(4 weeks)
  • Radiation exposure (Grays)(4 weeks)

研究者

申办方类型
Other
责任方
Sponsor

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