Post-traumatic Neuropathy of the Trigeminal Nerve

NCT ID: NCT04612855

Last Updated: 2020-11-04

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

1333 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-28

Study Completion Date

2020-10-01

Brief Summary

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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.

Detailed Description

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Conditions

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Nerve Injury Orofacial Pain Trigeminal Nerve Injuries Trigeminal Neuropathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Frederic Van der Cruyssen

Prinicipal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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dep. Oral & Maxillofacial Surgery

Leuven, Vlaams-Brabant, Belgium

Site Status

Countries

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Belgium

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.

Reference Type BACKGROUND
PMID: 29523381 (View on PubMed)

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.

Reference Type RESULT
PMID: 32687637 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34393199 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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http://www.uzleuven.be/nl/mond-kaak-en-aangezichtschirurgie/klinische-studies

Study website of the dep. of Oral and Maxillofacial surgery, UZ Leuven, Belgium

https://omfsimpath.be

Website of the research group OMFS-IMPATH

Other Identifiers

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S62333

Identifier Type: -

Identifier Source: org_study_id