Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06261853 |
| Other study ID # |
2-081-23 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 1, 2024 |
| Est. completion date |
May 2025 |
Study information
| Verified date |
May 2024 |
| Source |
University of Aberdeen |
| Contact |
Anand Lalli, BDS PhD |
| Phone |
01224553515 |
| Email |
anand.lalli[@]nhs.scot |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
