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

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.

Study Overview

• Status: Recruiting
• Conditions: Impacted Third Molar Tooth; Inferior Alveolar Nerve Injuries
• Intervention / Treatment: Radiation: 3D-CBCT; Radiation: 2D-OPG

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 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.

• Study Type: Interventional
• Enrollment (Estimated): 1292
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anand Lalli, BDS PhD; Phone Number: 01224553515; Email: anand.lalli@nhs.scot
• Study Contact Backup: Name: Rahmeh Alhyari, BDS MFDS RCSEd; Phone Number: 01224 437732; Email: r.alhyari.22@abdn.ac.uk

Study Locations

• United Kingdom
  • England
    • London, England, United Kingdom, SE5 9RS
      • Not yet recruiting
      • King's College Hospital NHS Foundation Trust
      • Contact: Nadine Khawaja, BDS PhD; Email: nadine.khawaja@kcl.ac.uk
      • Principal Investigator: Nadine Khawaja
  • Scotland
    • Aberdeen, Scotland, United Kingdom, AB25 2ZR
      • Recruiting
      • Aberdeen Dental Hospital
      • Contact: Anand Lalli, BDS PhD; Phone Number: 01224553515; Email: anand.lalli@nhs.scot
      • Principal Investigator: Anand Lalli, Consultant in Oral Surgery
      • Contact: Rahmeh Alhyari, BDS MFDS RCSEd; Email: r.alhyari.22@abdn.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 3D-CBCT Scan; 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; 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.; Other Names: Cone Beam Computerised Tomography; Small Volume Cone Beam CT
Active Comparator: 2D-OPG X-ray; 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; 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.; Other Names: Orthopantomography; Panoramic Dental X-ray

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	on the day of surgery
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.	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.	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.	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.	on the day of surgery

Collaborators and Investigators

• Sponsor: University of Aberdeen
• Collaborators: King's College London; Zarqa University
• Investigators: Study Chair: Anand Lalli, BDS PhD, Institute of Dentistry, University of Aberdeen; Study Director: Rahmeh Alhyari, BDS MFDS RCSEd, Institute of Dentistry, University of Aberdeen

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2024
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: February 7, 2024
• First Submitted That Met QC Criteria: February 7, 2024
• First Posted (Actual): February 15, 2024

Study Record Updates

• Last Update Posted (Actual): May 3, 2024
• Last Update Submitted That Met QC Criteria: May 2, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: CBCT; OPG; cone beam CT; nerve injury; impacted third molar; wisdom tooth; mandibular wisdom tooth
• Additional Relevant MeSH Terms: Nervous System Diseases; Stomatognathic Diseases; Mouth Diseases; Craniocerebral Trauma; Trauma, Nervous System; Cranial Nerve Diseases; Tooth Diseases; Facial Nerve Diseases; Trigeminal Nerve Diseases; Facial Neuralgia; Cranial Nerve Injuries; Trigeminal Nerve Injuries; Wounds and Injuries; Tooth, Impacted; Mandibular Nerve Injuries
• Other Study ID Numbers: 2-081-23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No