Nerve InjuryNCT04612855
Post-traumatic Neuropathy of the Trigeminal Nerve
An observational study of Nerve Injury and Orofacial Pain, run by KU Leuven at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Nerve Injury, Orofacial Pain, Trigeminal Nerve Injuries
- What is being tested?
- Groupwise comparison of primary and secondary outcomes
- How many people
- 1,333 participants
- Where
- 1 siteBelgium
- Study dates
- 28 Jan 2019to 1 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Neuropathic pain in another region than the trigeminal nerve
- Neuropathic pain not caused by iatrogenic injury
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Being tested
- Groupwise comparison of primary and secondary outcomes
- Keywords
- post-traumatic trigeminal neuropathic pain
- Medical subject headings
- Facial Pain, Trigeminal Nerve Injuries, Trigeminal Nerve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Groupwise comparison of primary and secondary outcomesOther
Statistical comparison of cohorts. Cfr supporting information on statistical plan.
| Study group | Role | What they receive |
|---|---|---|
| Painful post-traumatic trigeminal nerve injuries | Patients presenting with painful post-traumatic trigeminal nerve injuries according to the recent ICOP criteria. Receives: 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. Receives: 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. Receives: 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. Receives: Other: Groupwise comparison of primary and secondary outcomes |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)?
Measured: 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)?
Measured: 10 years
Secondary outcomes (6)
Clinical predictors of persistency
Are symptoms or clinical exam parameters (2 pointdiscrimination, directional sense, light touch, percentage of dermatome affected, pinprick threshold), MRCS classification and Sunderland classification predictive of a temporary or permanent injury? If so, which parameters can be withheld?
Measured: 10 years
Legal action
If data is present in the patient file regarding legal action taken by the patient against the caregiver who caused the injury this will be registered. We will evaluate how many patients undertook legal action and if they received compensation.
Measured: 10 years
Survival analysis
If sufficient follow up data is present, we will evaluate how long symptoms are present in case of a temporary injury and evaluate evolution of symptoms in relation to time.
Measured: 10 years
Influence of imaging on treatment decision
Was imaging performed in light of the injury? If yes, what imaging modality was used (conebeam CT, CT, MRI, orthopantomogram) and did this influence treatment decisions?
Measured: 10 years
PROMS comparison between cohorts
When looking at PROMS questionnaires applied in our department: are the results from the questionnaires comparable between the different causes of nerve injury, different affected branches? Are results comparable between patients suffering from a temporary or permanent injury?
Measured: 10 years
Quality of life between cohorts
Is there a correlation between quality of life measured with EQ5D questionnaire and cause of injury, temporary versus permanent injuries, healthcare costs, productivity loss or medication use?
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2020
- Study start28 Jan 2019
- Primary completion1 Jan 2020
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Nerve InjuryStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,333 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frederic Van der Cruyssen, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04612855
- Sponsor's protocol ID
- S62333
- Status last verified
- Nov 2020
- First submitted
- 28 Oct 2020
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Source data will be directly accessible to the rightful instance or person on request. All medical data, the data collected in the course of the study is treated with the utmost confidentiality. The medical secrecy, the international guidelines (ICH-GCP) and the Belgian legislation are complied with. The investigators undertake to respect the conditions in the European General Data Protection Regulation (Europese Algemene Verordening Gegevensbescherming, AVG) and the Belgian legislation on the protection of natural persons with regard to the processing of personal data. The CastorEDC (www.castoredc.com) platform will be used to ensure a systematic approach towards entering datapoints after accessing the patient record. After reading the patient record in KWS, all data will be coded immediately in the CastorEDC database by creating a new and unique identifier, the study ID.
Publications
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.
PubMed 29523381Van 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.
PubMed 32687637Van 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.
PubMed 34393199
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-traumatic Neuropathy of the Trigeminal Nerve
- ClinicalTrials.gov ID
- NCT04612855
- Acronym / sponsor ID
- S62333
- Keywords
- post-traumatic trigeminal neuropathic pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,333 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- 28 Jan 2019 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 3 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Painful post-traumatic trigeminal nerve injuries | – | Other: Groupwise comparison of primary and secondary outcomesPatients presenting with painful post-traumatic trigeminal nerve injuries according to the recent ICOP criteria. |
| Non-painful post-traumatic trigeminal nerve injuries | – | Other: Groupwise comparison of primary and secondary outcomesPatients presenting with non-painful post-traumatic trigeminal nerve injuries according to the recent ICOP criteria. |
| Temporary nerve injuries | – | Other: Groupwise comparison of primary and secondary outcomesPatients with a trigeminal nerve injury with symptom resolution within 3 months after data of trauma. |
| Persistent nerve injuries | – | Other: Groupwise comparison of primary and secondary outcomesPatients with a trigeminal nerve injury and complaints persisting longer than 3 months after the trauma. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Neuropathic pain in another region than the trigeminal nerve
- Neuropathic pain not caused by iatrogenic injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Groupwise comparison of primary and secondary outcomesStatistical comparison of cohorts. Cfr supporting information on statistical plan. | Other | Non-painful post-traumatic trigeminal nerve injuries, Painful post-traumatic trigeminal nerve injuries, Persistent nerve injuries, Temporary nerve injuries |
Primary outcome
Healthcare costs
Time frame: 10 years
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.
Productivity loss
Time frame: 10 years
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)?
Medication use
Time frame: 10 years
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)?
6 secondary outcomes
Clinical predictors of persistency
Time frame: 10 years
Legal action
Time frame: 10 years
Survival analysis
Time frame: 10 years
Influence of imaging on treatment decision
Time frame: 10 years
PROMS comparison between cohorts
Time frame: 10 years
Quality of life between cohorts
Time frame: 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
- Background: PubMed 29523381Klazen 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.
- Results publication: PubMed 32687637Van 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.
- Derived from this study: PubMed 34393199Van 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.
- Study website of the dep. of Oral and Maxillofacial surgery, UZ Leuven, BelgiumLink provided by the sponsor.
- Website of the research group OMFS-IMPATHLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Source data will be directly accessible to the rightful instance or person on request. All medical data, the data collected in the course of the study is treated with the utmost confidentiality. The medical secrecy, the international guidelines (ICH-GCP) and the Belgian legislation are complied with. The investigators undertake to respect the conditions in the European General Data Protection Regulation (Europese Algemene Verordening Gegevensbescherming, AVG) and the Belgian legislation on the protection of natural persons with regard to the processing of personal data. The CastorEDC (www.castoredc.com) platform will be used to ensure a systematic approach towards entering datapoints after accessing the patient record. After reading the patient record in KWS, all data will be coded immediately in the CastorEDC database by creating a new and unique identifier, the study ID.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nerve Injury and Orofacial Pain, run by KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healthcare costs (time frame: 10 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04612855, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2020.