Inferior Alveolar Nerve InjuriesIMPACTIONNCT06261853
The Impact of 3D-CBCT Imaging on Nerve Injuries During Wisdom Tooth Surgery
A study testing 3D-CBCT and 2D-OPG in people with Inferior Alveolar Nerve Injuries and Impacted Third Molar Tooth, run by University of Aberdeen at 2 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Inferior Alveolar Nerve Injuries, Impacted Third Molar Tooth
- What is being tested?
- 3D-CBCT and 2D-OPG
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,292 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 1 Feb 2024to May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites, 2 recruiting
- Recruiting
Aberdeen Dental Hospital
Aberdeen, Scotland, AB25 2ZR
Anand Lalli, BDS PhD, 01224553515, anand.lalli@nhs.scot
Rahmeh Alhyari, BDS MFDS RCSEd, r.alhyari.22@abdn.ac.uk
- Not yet recruiting
King'S College Hospital Nhs Foundation Trust
London, England, SE5 9RS
Nadine Khawaja, BDS PhD, nadine.khawaja@kcl.ac.uk
Nadine Khawaja
About this study
Official title: Determining the Clinical IMPACT of 3D-CBCT Imaging in Comparison to 2D-OPG on Nerve Injuries During Wisdom Tooth Surgery
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.
Read the detailed description
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?
The study intervention:
- 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.
- 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.
- 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.
- 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.
- Being tested
- 3D-CBCT, 2D-OPG
- Keywords
- nerve injury, wisdom tooth, impacted third molar, cone beam CT, OPG, CBCT, mandibular wisdom tooth
- Medical subject headings
- Mandibular Nerve Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D-CBCTRadiation
Also called Cone Beam Computerised Tomography, Small Volume Cone Beam CT
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.
2D-OPGRadiation
Also called Orthopantomography, Panoramic Dental X-ray
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.
| Study group | Role | What they receive |
|---|---|---|
| 3D-CBCT Scan | Experimental | The surgeons will only utilise the 3D-CBCT scan of their patient during wisdom tooth surgery. The patient should observe no difference in their care in this arm of the trial on the day of surgery as they wouldn't typically be aware of which image was being viewed Receives: Radiation: 3D-CBCT |
| 2D-OPG X-ray | Active comparator | The surgeons will only utilise the 2D-OPG X-ray of their patient during wisdom tooth surgery. The patient should observe no difference in their care in this arm of the trial on the day of surgery as they wouldn't typically be aware of which image was being viewed Receives: Radiation: 2D-OPG |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of patients reporting altered sensation in their lip and/or chin on the side of wisdom tooth 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.
Measured: one week after surgery
Secondary outcomes (5)
Surgical time
Surgery duration from initiation of the procedure (knife to mucosa or start of elevation etc. not including anaesthesia time) to the completion of closure of the wound (not including post-op instructions etc.). This will be evaluated using data from the intraoperative surgeon's proforma which is completed by the surgeon on the day of surgery.
Measured: on the day of surgery
Planned surgical approach
Surgical technique utilised either total removal (extraction) or intentional partial removal leaving the roots behind (coronectomy). This will be measured and reported using data from the intraoperative surgeon's proforma which is completed by the surgeon on the day of surgery.
Measured: on the day of surgery
Intraoperative complications
The quantity and type of intraoperative complications (excessive bleeding, unintentional root retention, nerve exposure). This will be evaluated using data from the intraoperative surgeon's proforma which is completed by the surgeon on the day of surgery.
Measured: on the day of surgery
Postoperative Complications
The quantity and type of postoperative complications (altered sensation in the tongue, persistent swelling, and analgesia intake). This will be evaluated using data collected from a series of yes/no questions asked during the follow-up phone call.
Measured: one week after surgery
Wisdom tooth impaction classification
The classification of wisdom tooth impaction. This will be evaluated using data from the intraoperative surgeon's proforma which is completed by the surgeon on the day of surgery.
Measured: on the day of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start1 Feb 2024
- Primary completionMay 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inferior Alveolar Nerve InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pragmatic, two-arm, single-blinded, randomised controlled trial designed to investigate the differences between 3D cone-beam computerised tomography (CBCT) and 2D orthopantomography (OPG) in reducing inferior alveolar nerve injuries during wisdom tooth surgery.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1,292 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aberdeen
- Sponsor type
- University, hospital or other
- Collaborators
- Zarqa University, King's College London
- Responsible party
- Sponsor
- Investigators
- Anand Lalli, BDS PhD, Study chair, Institute of Dentistry, University of AberdeenRahmeh Alhyari, BDS MFDS RCSEd, Study director, Institute of Dentistry, University of Aberdeen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06261853
- Sponsor's protocol ID
- 2-081-23
- Acronym
- IMPACTION
- Status last verified
- May 2024
- First submitted
- 7 Feb 2024
- Last updated
- 3 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Clinical IMPACT of 3D-CBCT Imaging in Comparison to 2D-OPG on Nerve Injuries During Wisdom Tooth Surgery
- ClinicalTrials.gov ID
- NCT06261853
- Acronym / sponsor ID
- IMPACTION / 2-081-23
- Keywords
- nerve injury, wisdom tooth, impacted third molar, cone beam CT, OPG, CBCT, mandibular wisdom tooth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,292 participants (estimated)
- Lead sponsor
- University of AberdeenUniversity, hospital or other
- Collaborators
- Zarqa University, King's College London
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 15 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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?
The study intervention:
- 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.
- 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.
- 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.
- 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Pragmatic, two-arm, single-blinded, randomised controlled trial designed to investigate the differences between 3D cone-beam computerised tomography (CBCT) and 2D orthopantomography (OPG) in reducing inferior alveolar nerve injuries during wisdom tooth surgery.
| Arm | Type | Receives |
|---|---|---|
| 3D-CBCT Scan | Experimental | Radiation: 3D-CBCTThe surgeons will only utilise the 3D-CBCT scan of their patient during wisdom tooth surgery. The patient should observe no difference in their care in this arm of the trial on the day of surgery as they wouldn't typically be aware of which image was being viewed |
| 2D-OPG X-ray | Active comparator | Radiation: 2D-OPGThe surgeons will only utilise the 2D-OPG X-ray of their patient during wisdom tooth surgery. The patient should observe no difference in their care in this arm of the trial on the day of surgery as they wouldn't typically be aware of which image was being viewed |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D-CBCTAlso: Cone Beam Computerised Tomography, Small Volume Cone Beam CTCBCT 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 | 3D-CBCT Scan |
| 2D-OPGAlso: Orthopantomography, Panoramic Dental X-rayAn 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. | Radiation | 2D-OPG X-ray |
Primary outcome
The number of patients reporting altered sensation in their lip and/or chin on the side of wisdom tooth surgery
Time frame: 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.
5 secondary outcomes
Surgical time
Time frame: on the day of surgery
Planned surgical approach
Time frame: on the day of surgery
Intraoperative complications
Time frame: on the day of surgery
Postoperative Complications
Time frame: one week after surgery
Wisdom tooth impaction classification
Time frame: on the day of surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
- Individual participant dataSharing planned: No
Related trials for Inferior Alveolar Nerve Injuries
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Infraorbital Nerve Injury, Inferior Alveolar Nerve Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anand Lalli, BDS PhD study chair
Institute of Dentistry, University of Aberdeen
Rahmeh Alhyari, BDS MFDS RCSEd study director
Institute of Dentistry, University of Aberdeen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D-CBCT and 2D-OPG in people with Inferior Alveolar Nerve Injuries and Impacted Third Molar Tooth, run by University of Aberdeen at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anand Lalli, BDS PhD (01224553515, anand.lalli@nhs.scot), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of patients reporting altered sensation in their lip and/or chin on the side of wisdom tooth surgery (time frame: one week after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2024.