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

NCT06261853 | Recruiting DMC

• 1 other identifier: 2-081-23
• Study Type: interventional
• Target: 1,292
• Locations: 1 country
• Sites: 2

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 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.

Conditions

Inferior Alveolar Nerve Injuries; Impacted Third Molar Tooth

Keywords

nerve injury; wisdom tooth; impacted third molar; cone beam CT; OPG; CBCT; mandibular wisdom tooth

Outcome Measures

Primary Outcomes (1)

• 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.

  one week after surgery

Secondary Outcomes (5)

• Surgical time

  on the day of surgery

• Planned surgical approach

  on the day of surgery

• Intraoperative complications

  on the day of surgery

• Postoperative Complications

  one week after surgery

• Wisdom tooth impaction classification

  on the day of surgery

Study Arms (2)

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

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

Radiation: 2D-OPG

Interventions

3D-CBCT RADIATION

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.

Also known as: Cone Beam Computerised Tomography, Small Volume Cone Beam CT

3D-CBCT Scan

2D-OPG RADIATION

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.

Also known as: Orthopantomography, Panoramic Dental X-ray

2D-OPG X-ray

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Aberdeen: lead
• Zarqa University: collaborator
• King's College London: collaborator

Study Sites (2)

King'S College Hospital Nhs Foundation Trust

London, England, SE5 9RS, United Kingdom

NOT YET RECRUITING

Aberdeen Dental Hospital

Aberdeen, Scotland, AB25 2ZR, United Kingdom

RECRUITING

MeSH Terms

Conditions

Mandibular Nerve Injuries

Interventions

Radiography, Panoramic

Condition Hierarchy (Ancestors)

Trigeminal Nerve Injuries; Trigeminal Nerve Diseases; Facial Neuralgia; Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Injuries; Cranial Nerve Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Radiography, Dental; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnosis, Oral; Dentistry

Study Officials

• Anand Lalli, BDS PhD

  Institute of Dentistry, University of Aberdeen

  STUDY CHAIR

• Rahmeh Alhyari, BDS MFDS RCSEd

  Institute of Dentistry, University of Aberdeen

  STUDY DIRECTOR

Central Study Contacts

Anand Lalli, BDS PhD

CONTACT

01224553515; anand.lalli@nhs.scot

Rahmeh Alhyari, BDS MFDS RCSEd

CONTACT

01224 437732; r.alhyari.22@abdn.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double (Participant, Outcomes Assessor) A single-blinded methodology will be employed due to the nature of the image-based investigation where the surgeon is required to utilise one imaging modality during the surgery. In order to eliminate any influence or bias on the outcomes and data obtained for the primary objective, both the subject (patient) and the study member who will do the follow-up call will be blinded to the imaging techniques used on the day of surgery.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 7, 2024
• First Posted: February 15, 2024
• Study Start: February 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: May 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)