Clinical trial NCT04612855: Post-traumatic Neuropathy of the Trigeminal Nerve
Official title: Post-traumatic Neuropathy of the Trigeminal Nerve
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nerve Injury
Orofacial Pain
Trigeminal Nerve Injuries
Trigeminal Neuropathy
Keywords: post-traumatic trigeminal neuropathic pain
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2020-11-03
Enrollment: 1333
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with post- traumatic, including iatrogenic, injury to branches of the trigeminal nerve seen at the department of Oral \& Maxillofacial Surgery at UZ Leuven between January 2010 and October 2018 and possible subsequent post-traumatic neuropathy (PTN). To improve statistical power, the coded dataset from a retrospective study by prof. Tara Renton, co-investigator, will be provided to the principal investigator of the current study (dr. Fréderic Van der Cruyssen) and merged with the dataset acquired in this study to further analyze presentation, symptoms, clinical exam, radiographic evaluation, treatments and outcome parameters. The dataset provided by prof. Tara Renton was build by using the same inclusion and exclusion criteria between January 2010 and October 2018. This should allow for a justified merging of both datasets. Statistical analysis will determine correlation of data.

Brief summary: This is retrospective research mainly aims to determine the patterns of symptoms, clinical and radiological findings and outcomes in patients with trigeminal neuropathy following trauma or iatrogenic damage and how this translates into costs for the patient and society, work disability and medication use.

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.


Eligibility criteria: Inclusion Criteria:

* Presentation with post traumatic, iatrogenic, injury of the trigeminal nerve or its branches (eg. inferior alveolar nerve, lingual nerve)
* 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 in another region than the trigeminal nerve
* Neuropathic pain not caused by iatrogenic injury

Primary outcomes:
measure: Healthcare costs
timeFrame: 10 years
measure: Productivity loss
timeFrame: 10 years
measure: Medication use
timeFrame: 10 years
Secondary outcomes:
measure: Clinical predictors of persistency
timeFrame: 10 years
measure: Legal action
timeFrame: 10 years
measure: Survival analysis
timeFrame: 10 years
measure: Influence of imaging on treatment decision
timeFrame: 10 years
measure: PROMS comparison between cohorts
timeFrame: 10 years
measure: Quality of life between cohorts
timeFrame: 10 years
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: dep. Oral & Maxillofacial Surgery
state: Vlaams-Brabant
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.