protocolSection identificationModule nctId: NCT06261853, orgStudyIdInfo id: 2-081-23, briefTitle: The Impact of 3D-CBCT Imaging on Nerve Injuries During Wisdom Tooth Surgery, acronym: IMPACTION, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2025-05, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: University of Aberdeen, class: OTHER, collaborators name: Zarqa University, collaborators name: King's College London, descriptionModule briefSummary: 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., conditionsModule conditions: Inferior Alveolar Nerve Injuries, conditions: Impacted Third Molar Tooth, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 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., primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, maskingDescription: 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., whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 1292, type: ESTIMATED, armsInterventionsModule interventions name: 3D-CBCT, interventions name: 2D-OPG, outcomesModule primaryOutcomes measure: The number of patients reporting altered sensation in their lip and/or chin on the side of wisdom tooth surgery, secondaryOutcomes measure: Surgical time, secondaryOutcomes measure: Planned surgical approach, secondaryOutcomes measure: Intraoperative complications, secondaryOutcomes measure: Postoperative Complications, secondaryOutcomes measure: Wisdom tooth impaction classification, eligibilityModule sex: ALL, minimumAge: 16 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: King'S College Hospital Nhs Foundation Trust, city: London, state: England, zip: SE5 9RS, country: United Kingdom, contacts name: Nadine Khawaja, BDS PhD, role: CONTACT, email: nadine.khawaja@kcl.ac.uk, contacts name: Nadine Khawaja, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.50853, lon: -0.12574, locations facility: Aberdeen Dental Hospital, city: Aberdeen, state: Scotland, zip: AB25 2ZR, country: United Kingdom, contacts name: Anand Lalli, BDS PhD, role: CONTACT, phone: 01224553515, email: anand.lalli@nhs.scot, contacts name: Rahmeh Alhyari, BDS, role: CONTACT, email: r.alhyari.22@abdn.ac.uk, contacts name: Anand Lalli, Consultant in Oral Surgery, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 57.14369, lon: -2.09814, hasResults: False