Post-traumatic Neuropathy of the Trigeminal Nerve

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04612855
Study type	Observational
Source	KU Leuven
Contact
Status	Completed
Phase
Start date	January 28, 2019
Completion date	October 1, 2020

View Details

See also
Status	Clinical Trial	Phase
Enrolling by invitation	`NCT01437332` - Molecular Mediators of Nerve Injury Signaling	N/A
Completed	`NCT03624426` - Detection and Prevention of Nerve Injury in Shoulder Arthroplasty Surgery	N/A
Recruiting	`NCT04662320` - Promoting Healing Of Nerves Through Electrical Stimulation	N/A
Recruiting	`NCT04144972` - Closed-Loop Deep Brain Stimulation for Refractory Chronic Pain	N/A
Completed	`NCT02960516` - MRI Diffusion Tensor Tractography to Monitor Peripheral Nerve Recovery After Severe Crush or Cut/Repair Nerve Injury
Completed	`NCT05589324` - Effects of 3D Printing Writing Assisitive Device on Feasibility in Patients With Nerve Injury
Recruiting	`NCT03970161` - Evaluation of Early Retinal Nerve Injury in Type 2 Diabetes Patients Without Diabetic Retinopathy	N/A
Completed	`NCT01533337` - Free Dorsal Digital Flap for Reconstruction of Volar Soft Tissue Defect of Digits	N/A
Completed	`NCT01528397` - Reconstruction of Proper Digital Nerve Defects in the Thumb Using a Pedicled Nerve Graft	N/A
Enrolling by invitation	`NCT05080608` - Nerve Injury in the Hand, an Interview Study
Completed	`NCT03881462` - Deltoid Muscle Contribution to Shoulder Function	N/A
Completed	`NCT05302141` - Effects of Assistive Device on ADL Function in Patients With Nerve Injury	N/A
Terminated	`NCT01751503` - Extramembranous and Interosseous Technique of Tibialis Posterior Tendon Transfer	N/A
Recruiting	`NCT05365282` - Association Between Radial Artery Intervention and Development of Neuropathy in the Hand - A Prospective Study
Active, not recruiting	`NCT03701581` - 4-aminopyridine Treatment for Nerve Injury	Phase 2/Phase 3
Withdrawn	`NCT04270019` - Polyethylene Glycol to Improve Sensation Following Digital Nerve Laceration	Phase 1/Phase 2
Completed	`NCT04420689` - A Study of ALM-488 to Highlight Nerves in Patients Undergoing Head & Neck Surgery	Phase 1/Phase 2
Recruiting	`NCT05884125` - Promoting Healing of Injured Nerves With Electrical Stimulation Therapy	N/A
Recruiting	`NCT05611983` - Experience and Feasibility of Methods for Early Sensory Training	N/A
Completed	`NCT02032030` - Systematic Assessment and Targeted Improvement of Services Following Yearlong Surgical Outcomes Surveys

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.