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Post-traumatic Neuropathy of the Trigeminal Nerve

C

Catholic University (KU) of Leuven

Status

Completed

Conditions

Trigeminal Nerve Injuries
Orofacial Pain
Trigeminal Neuropathy
Nerve Injury

Treatments

Other: Groupwise comparison of primary and secondary outcomes

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

1,333 patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial design

1,333 participants in 4 patient groups

Painful post-traumatic trigeminal nerve injuries
Description:
Patients presenting with painful post-traumatic trigeminal nerve injuries according to the recent ICOP criteria.
Treatment:
Other: Groupwise comparison of primary and secondary outcomes
Non-painful post-traumatic trigeminal nerve injuries
Description:
Patients presenting with non-painful post-traumatic trigeminal nerve injuries according to the recent ICOP criteria.
Treatment:
Other: Groupwise comparison of primary and secondary outcomes
Temporary nerve injuries
Description:
Patients with a trigeminal nerve injury with symptom resolution within 3 months after data of trauma.
Treatment:
Other: Groupwise comparison of primary and secondary outcomes
Persistent nerve injuries
Description:
Patients with a trigeminal nerve injury and complaints persisting longer than 3 months after the trauma.
Treatment:
Other: Groupwise comparison of primary and secondary outcomes

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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