NCT06261853

The Impact of 3D-CBCT Imaging on Nerve Injuries During Wisdom Tooth Surgery

Determining the Clinical IMPACT of 3D-CBCT Imaging in Comparison to 2D-OPG on Nerve Injuries During Wisdom Tooth Surgery

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,292 (estimated)
• Sponsor: University of Aberdeen · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This pragmatic clinical trial is a multi-centre, two-arm, single-blind randomised controlled trial. The primary research question is: 1\. 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: 1. Does the additional information provided by the 3D scan, over the 2D x-ray, reduce the operation time? 2. 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? 3. 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? The study intervention: 1. On the day of surgery, the surgeon will utilise only one imaging technique, either the 2D OPG or the 3D CBCT, during wisdom tooth surgery. The trial arm allocation will be noted on their operating list alongside the planned procedure details. Conventionally, surgeons would have access to both images and therefore, it is difficult to determine the relative impact of each on surgical outcomes. The patient should observe no difference in their care in either arm of the trial on the day of surgery as they wouldn't typically be aware of which image was being utilised. 2. Data will be collected peri-operatively by way of a proforma completed by the surgeon. If the surgeon feels the need to use the other imaging modality to which the patient is allocated, for example, to maintain standards of care, this will be recorded along with the reasons why. Operating time and intraoperative complications will also be documented for each surgical procedure. 3. One week after the surgery, participants will receive a follow-up phone call from a research team member, which should last no more than five minutes. They will be asked five 'yes/no' questions about their recovery. Typically, patients having wisdom tooth surgery are not routinely followed up after their surgery unless specifically requested by the surgeon, therefore, this could be seen as an improved level of care for most patients especially as the research team member will have access to the post-operative care instructions from the department and can ask a surgeon to contact the patient if requested or deemed necessary. 4. After the one-week postoperative telephone review, the participant will be discharged from the study even if they continue to receive post-operative care, as clinically indicated, from their surgeon. If the patient is subsequently listed for another wisdom tooth surgical procedure and still meets the inclusion criteria, they may be invited to enrol again in the study.

Conditions

• Inferior Alveolar Nerve Injuries
• Impacted Third Molar Tooth

Interventions

Type	Name	Description
RADIATION	3D-CBCT	CBCT provides a three-dimensional image of the hard tissue structures and their anatomical relationships such as the root of the wisdom tooth and the inferior dental canal. CBCT radiation doses are typically in the range of 60 microSv.
RADIATION	2D-OPG	An OPG provides a two-dimensional image of the hard tissue structures and their anatomical relationships such as the root of the wisdom tooth and the inferior dental canal. OPG radiation doses are typically in the range of 20 microSv.

Timeline

• Start date: 2024-02-01
• Primary completion: 2025-05-01
• Completion: 2025-05-01
• First posted: 2024-02-15
• Last updated: 2024-05-03

Locations

2 sites across 1 country: United Kingdom