Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1333 participants
OBSERVATIONAL
2019-01-28
2020-10-01
Brief Summary
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The trigeminal nerve and its branches are at risk of damage during multiple dental and maxillofacial procedures: endodontics, extractions, removal of wisdom teeth, implant placement, use of local anaesthesia, orthognatic surgery.
In the event of damage to these nerve branches, there is a high risk of developing a neuropathic pain that is considered very disabling for patients and that interferes with daily activities (eating, drinking, speaking, kissing, etc.). Moreover, there are few medicinal or surgical techniques available to eliminate neuropathy or reduce the symptoms.
Causal procedures (e.g. the removal of wisdom teeth) are among the most frequently performed surgical procedures. The number of injuries increases every year, partly due to an increase in dental procedures. The often relatively minimal intervention combined with the major impact of these injuries on the patient's quality of life sometimes leads to medico-legal actions. The limited symptom control with current therapies of these post-traumatic neuropathies of the trigeminal nerve causes frustration and impotence in both the patient and the attending physician, which can also lead to medical shopping.
Based on chart analysis, this study will examine the causes, possible risk factors and presenting symptoms, how this is reflected in clinical research and examinations, and which treatments are being instituted. Patient records from the Oral and Maxillofacial Surgery department between January 2010 and October 2018 will be checked. In addition, we wish to check the costs incurred by these patients as well as the work disability. To this end, a collaboration is being organised with Christian Mutuality (CM), the largest health insurance provider in Belgium.
In order to increase the power of the study, the clinical data from the already coded, retrospective dataset of Prof. Tara Renton, co-investigator, will be transferred to the dataset of this new study.
Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Painful post-traumatic trigeminal nerve injuries
Patients presenting with painful post-traumatic trigeminal nerve injuries according to the recent ICOP criteria.
Groupwise comparison of primary and secondary outcomes
Statistical comparison of cohorts. Cfr supporting information on statistical plan.
Non-painful post-traumatic trigeminal nerve injuries
Patients presenting with non-painful post-traumatic trigeminal nerve injuries according to the recent ICOP criteria.
Groupwise comparison of primary and secondary outcomes
Statistical comparison of cohorts. Cfr supporting information on statistical plan.
Temporary nerve injuries
Patients with a trigeminal nerve injury with symptom resolution within 3 months after data of trauma.
Groupwise comparison of primary and secondary outcomes
Statistical comparison of cohorts. Cfr supporting information on statistical plan.
Persistent nerve injuries
Patients with a trigeminal nerve injury and complaints persisting longer than 3 months after the trauma.
Groupwise comparison of primary and secondary outcomes
Statistical comparison of cohorts. Cfr supporting information on statistical plan.
Interventions
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Groupwise comparison of primary and secondary outcomes
Statistical comparison of cohorts. Cfr supporting information on statistical plan.
Eligibility Criteria
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Inclusion Criteria
* Iatrogenic nerve injury caused by M3 removal, implant placement, orthognathic surgery, endodontic therapy, non-M3 removal, local anesthesia injection, trauma.
* Clinical diagnosis of neurosensory deficit in the distribution of the trigeminal nerve caused by a previous dental or maxillofacial procedure in the vicinity of the affected branch.
Exclusion Criteria
* Neuropathic pain not caused by iatrogenic injury
ALL
No
Sponsors
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KU Leuven
OTHER
Responsible Party
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Frederic Van der Cruyssen
Prinicipal investigator
Locations
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dep. Oral & Maxillofacial Surgery
Leuven, Vlaams-Brabant, Belgium
Countries
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References
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Klazen Y, Van der Cruyssen F, Vranckx M, Van Vlierberghe M, Politis C, Renton T, Jacobs R. Iatrogenic trigeminal post-traumatic neuropathy: a retrospective two-year cohort study. Int J Oral Maxillofac Surg. 2018 Jun;47(6):789-793. doi: 10.1016/j.ijom.2018.02.004. Epub 2018 Mar 6.
Van der Cruyssen F, Peeters F, Gill T, De Laat A, Jacobs R, Politis C, Renton T. Signs and symptoms, quality of life and psychosocial data in 1331 post-traumatic trigeminal neuropathy patients seen in two tertiary referral centres in two countries. J Oral Rehabil. 2020 Oct;47(10):1212-1221. doi: 10.1111/joor.13058. Epub 2020 Aug 2.
Van der Cruyssen F, Peeters F, De Laat A, Jacobs R, Politis C, Renton T. Prognostic factors, symptom evolution, and quality of life of posttraumatic trigeminal neuropathy. Pain. 2022 Apr 1;163(4):e557-e571. doi: 10.1097/j.pain.0000000000002408.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Study website of the dep. of Oral and Maxillofacial surgery, UZ Leuven, Belgium
Website of the research group OMFS-IMPATH
Other Identifiers
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S62333
Identifier Type: -
Identifier Source: org_study_id