Using 3D imaging to reduce 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
This study is testing if using 3D imaging instead of regular 2D X-rays during wisdom tooth surgery can help prevent nerve injuries and make the surgery safer for patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1292 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | University of Aberdeen Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (London, England and 1 other locations) |
| Trial ID | NCT06261853 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates whether 3D cone beam computed tomography (CBCT) imaging can reduce the risk of nerve injuries during wisdom tooth surgery compared to traditional 2D panoramic X-rays. It is a multi-centre, two-arm, single-blind randomized controlled trial where participants will undergo surgery using either 3D or 2D imaging. The study aims to assess not only the incidence of nerve injuries but also the operation time and complications associated with each imaging technique. Data will be collected by surgeons during the procedure to evaluate the effectiveness of the imaging methods.
Who should consider this trial
Good fit: Ideal candidates include individuals over 16 years old who require surgical treatment for a mandibular wisdom tooth and have a 2D-OPG x-ray available.
Not a fit: Patients with pre-existing neurological deficits or those who do not require wisdom tooth surgery will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly lower the incidence of nerve injuries during wisdom tooth extractions, improving patient outcomes and quality of life.
How similar studies have performed: While the use of 3D imaging in dental procedures is gaining traction, this specific comparison of 3D versus 2D imaging in reducing nerve injuries during wisdom tooth surgery is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 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. 2. Individuals requiring a 3D-CBCT to further assess the relationship between the wisdom tooth and the inferior alveolar nerve. 3. 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. 4. 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. 5. Individuals over the age of 16 and willing and able to provide valid informed consent for themselves. 6. Individuals with adequate English comprehension to read the written PIS and consent form and understand the follow-up call questions. 7. Individuals willing to provide contact details to allow a telephone follow-up call one week after their surgery. Exclusion Criteria: 1. Individuals who do not have the capacity to consent for themselves. 2. Individuals taking medicines or having medical conditions and disorders that impair neurosensory function. 3. 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. 4. Individuals who are unable to read or speak English.
Where this trial is running
London, England and 1 other locations
- King'S College Hospital Nhs Foundation Trust — London, England, United Kingdom (Not_yet_recruiting)
- Aberdeen Dental Hospital — Aberdeen, Scotland, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Anand Lalli, BDS PhD
- Email: anand.lalli@nhs.scot
- Phone: 01224553515
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.