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| Name | Class |
|---|---|
| Zarqa University | UNKNOWN |
| King's College London | OTHER |
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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.
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:
The study intervention:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anand Lalli, BDS PhD | Contact | 01224553515 | anand.lalli@nhs.scot | |
| Rahmeh Alhyari, BDS MFDS RCSEd | Contact | 01224 437732 | r.alhyari.22@abdn.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King'S College Hospital Nhs Foundation Trust | Not yet recruiting | London | England | SE5 9RS | United Kingdom |
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| ID | Term |
|---|---|
| D000080902 | Mandibular Nerve Injuries |
| ID | Term |
|---|---|
| D061221 | Trigeminal Nerve Injuries |
| D020433 | Trigeminal Nerve Diseases |
| D005156 | Facial Neuralgia |
| D005155 | Facial Nerve Diseases |
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| ID | Term |
|---|---|
| D011862 | Radiography, Panoramic |
| ID | Term |
|---|---|
| D011861 | Radiography, Dental |
| D011859 | Radiography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
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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.
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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.
|
| 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. |
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| 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 |
| 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 |
| 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 |
| Aberdeen Dental Hospital | Recruiting | Aberdeen | Scotland | AB25 2ZR | United Kingdom |
|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D020209 | Cranial Nerve Injuries |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D003933 | Diagnosis |
| D003945 | Diagnosis, Oral |
| D003813 | Dentistry |