Determining the Clinical IMPACT of 3D-CBCT Imaging in Comparison to 2D-OPG on Nerve Injuries During Wisdom Tooth Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,292
- 试验地点
- 4
- 主要终点
- The number of patients reporting altered sensation in their lip and/or chin on the side of wisdom tooth surgery
研究概览
简要总结
The investigators aim to investigate if the additional information available from a 3D scan of the wisdom tooth can reduce the risk of nerve injury during wisdom tooth surgery compared to conventional 2D images.
Wisdom tooth surgery is a common surgical procedures that a significant proportion of the population will undergo. As with any other surgical procedure, there are potential complications, of which, injury to the nerve supplying feeling to the lip, chin, and tongue is the most significant. This can lead to persistent pain, tingling, or numbness that may impact a patient's ability to eat and function.
The risk of nerve injury during wisdom tooth surgery is assessed using X-ray images, which show the position of the nerve and tooth in the jawbone. 2D and 3D scans are used, which have their own advantages and disadvantages such as reduced cost and radiation dose with 2D or more information from 3D images, but it remains unclear which is better at reducing the risk of nerve injuries.
详细描述
This pragmatic clinical trial is a multi-centre, two-arm, single-blind randomised controlled trial.
The primary research question is:
- Does the additional information provided by a 3D scan, over a 2D x-ray, reduce the number of nerve injuries occurring during wisdom tooth surgery.
The secondary objectives are:
- Does the additional information provided by the 3D scan, over the 2D x-ray, reduce the operation time?
- Does the additional information provided by the 3D scan, over the 2D x-ray, impact the number and type of complications occuring during wisdom tooth surgery?
- Does the additional information provided by the 3D scan, over the 2D x-ray, impact the number and type of complications observed after wisdom tooth surgery?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Double (Participant, Outcomes Assessor) A single-blinded methodology will be employed due to the nature of the image-based investigation where the surgeon is required to utilise one imaging modality during the surgery. In order to eliminate any influence or bias on the outcomes and data obtained for the primary objective, both the subject (patient) and the study member who will do the follow-up call will be blinded to the imaging techniques used on the day of surgery.
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals are seen in the Oral Surgery department with a 2D-OPG x-ray and a diagnosis of a mandibular wisdom tooth that requires surgical treatment.
- •Individuals requiring a 3D-CBCT to further assess the relationship between the wisdom tooth and the inferior alveolar nerve.
- •Individuals who are to undergo surgical treatment for their wisdom tooth regardless of the surgical approach (e.g. coronectomy or extraction) or the anaesthetic technique utilised.
- •Individuals without any pre-existing neurological deficit of cranial nerve V (trigeminal nerve) or medical conditions or medications that may cause changes in neurosensory function.
- •Individuals over the age of 16 and willing and able to provide valid informed consent for themselves.
- •Individuals with adequate English comprehension to read the written PIS and consent form and understand the follow-up call questions.
- •Individuals willing to provide contact details to allow a telephone follow-up call one week after their surgery.
排除标准
- •Individuals who do not have the capacity to consent for themselves.
- •Individuals taking medicines or having medical conditions and disorders that impair neurosensory function.
- •Individuals requiring wisdom tooth surgery to manage associated pathology such as cysts, fractures, or tumours where the pathological condition may interfere with the neurosensory function of the trigeminal nerve at 1 week post-operatively.
- •Individuals who are unable to read or speak English.
结局指标
主要结局
The number of patients reporting altered sensation in their lip and/or chin on the side of wisdom tooth surgery
时间窗: one week after surgery
The primary outcome measure is assessed by a series of yes/no questions asked during the follow-up call one week after the surgery.
次要结局
- Planned surgical approach(on the day of surgery)
- Wisdom tooth impaction classification(on the day of surgery)
- Surgical time(on the day of surgery)
- Intraoperative complications(on the day of surgery)
- Postoperative Complications(one week after surgery)