Ignite Creation Date:
2024-05-06 @ 8:08 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06261853
Status:
RECRUITING
Last Update Posted:
2024-05-03
First Post:
2024-02-07
Brief Title:
The Impact of 3D-CBCT Imaging on Nerve Injuries During Wisdom Tooth Surgery
Sponsor:
University of Aberdeen
Organization:
University of Aberdeen
Study Overview
Official Title:
Determining the Clinical IMPACT of 3D-CBCT Imaging in Comparison to 2D-OPG on Nerve Injuries During Wisdom Tooth Surgery
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IMPACTION
Brief 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 patients 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
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 patients 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 wouldnt 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 yesno 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
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 wouldnt 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 yesno 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None