Post-traumatic Neuropathy of the Trigeminal Nerve

NCT04612855 | Completed DMC

• 1 other identifier: S62333
• Study Type: observational
• Target: 1,333
• Locations: 1 country
• Sites: 1

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.

Conditions

Nerve Injury; Orofacial Pain; Trigeminal Nerve Injuries; Trigeminal Neuropathy

Keywords

post-traumatic trigeminal neuropathic pain

Outcome Measures

Primary Outcomes (3)

• Healthcare costs

  What is the difference in total healthcare costs per patient and in total in patients with iatrogenic trigeminal nerve injury seen in our department according to cause of injury, injured nerve and outcome (temporary or permanent injury)? * A temporary injury will be defined as an injury that completely recovered with no more symptoms and clinical exam parameters within the normal limits during one of the consultations during the follow up period. * Permanent injury will be defined as an injury where no significant improvement in symptoms or clinical exam parameters was seen during one of the consultations during the follow up period.

  10 years

• Productivity loss

  What is the average productivity loss in days in patients with iatrogenic trigeminal nerve injury seen in our department according to cause of injury, injured nerve and outcome (temporary or permanent injury)?

  10 years

• Medication use

  Amount of medication use per medication class per patient in patients with iatrogenic trigeminal nerve injury seen in our department according to cause of injury, injured nerve and outcome (temporary or permanent injury)?

  10 years

Secondary Outcomes (6)

• Clinical predictors of persistency

  10 years

• Legal action

  10 years

• Survival analysis

  10 years

• Influence of imaging on treatment decision

  10 years

• PROMS comparison between cohorts

  10 years

Study Arms (4)

Painful post-traumatic trigeminal nerve injuries

Patients presenting with painful post-traumatic trigeminal nerve injuries according to the recent ICOP criteria.

Other: Groupwise comparison of primary and secondary outcomes

Non-painful post-traumatic trigeminal nerve injuries

Patients presenting with non-painful post-traumatic trigeminal nerve injuries according to the recent ICOP criteria.

Other: Groupwise comparison of primary and secondary outcomes

Temporary nerve injuries

Patients with a trigeminal nerve injury with symptom resolution within 3 months after data of trauma.

Other: Groupwise comparison of primary and secondary outcomes

Persistent nerve injuries

Patients with a trigeminal nerve injury and complaints persisting longer than 3 months after the trauma.

Other: Groupwise comparison of primary and secondary outcomes

Interventions

Groupwise comparison of primary and secondary outcomes OTHER

Statistical comparison of cohorts. Cfr supporting information on statistical plan.

Non-painful post-traumatic trigeminal nerve injuries; Painful post-traumatic trigeminal nerve injuries; Persistent nerve injuries; Temporary nerve injuries

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Neuropathic pain in another region than the trigeminal nerve
• Neuropathic pain not caused by iatrogenic injury

Sponsors & Collaborators

• KU Leuven: lead

Study Sites (1)

dep. Oral & Maxillofacial Surgery

Leuven, Vlaams-Brabant, 3000, Belgium

Location

Related Publications (3)

• 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.

  PMID: 29523381 BACKGROUND

• 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.

  PMID: 32687637 RESULT

• 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.

  PMID: 34393199 DERIVED

Related Links

• Study website of the dep. of Oral and Maxillofacial surgery, UZ Leuven, Belgium
• Website of the research group OMFS-IMPATH

MeSH Terms

Conditions

Facial Pain; Trigeminal Nerve Injuries; Trigeminal Nerve Diseases

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Facial Neuralgia; Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Injuries; Cranial Nerve Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal investigator

Study Record Dates

• First Submitted: October 28, 2020
• First Posted: November 3, 2020
• Study Start: January 28, 2019
• Primary Completion: January 1, 2020
• Study Completion: October 1, 2020
• Last Updated: November 4, 2020

Record last verified: 2020-11

Locations

BE (1)