Neurosensory Function of Inferior Alveolar NerveNCT02634840
Assessment of Nerve Function After Mandible Surgery With a Modified Bilateral Sagittal Split Osteotomy Technique
A study testing bilateral sagittal split osteotomy in people with Neurosensory Function of Inferior Alveolar Nerve, run by Chang Gung Memorial Hospital.
Trial summary
Several technical modifications based on the anatomical position of the neurovascular bundle and its bony mandibular canal have been developed, aiming to prevent injury to the intraalveolar nerve We hypothesized that the incidence of neurosensory disturbance (NSD) should be reduced using our bilateral sagittal split… Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Neurosensory Function of Inferior Alveolar Nerve
- What is being tested?
- bilateral sagittal split osteotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Feb 2015
- Phase
- Interventional
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients receiving mandibular bilateral sagittal split osteotomy during orthognathic surgery with normal preoperative intraalveolar nerve function
- patients with cleft lip/palate or hemifacial microsomia were also included
Who cannot join
- craniofacial syndromic condition, abnormal psychomotor development or previous history of mandibular fracture
About this study
Official title: A Modified Technique of Mandibular Ramus Sagittal Split Osteotomy for Prevention of Inferior Alveolar Nerve Injury: A Prospective Cohort Study and Outcome Assessment
Several technical modifications based on the anatomical position of the neurovascular bundle and its bony mandibular canal have been developed, aiming to prevent injury to the intraalveolar nerve We hypothesized that the incidence of neurosensory disturbance (NSD) should be reduced using our bilateral sagittal split osteotomy (BSSO) technique, because direct intra-alveolar nerve injury can be avoided. The aim of this study was to introduce our modified BSSO technique and evaluate the subsequent incidence of postoperative neurosensory disturbance of the IAN.
Read the detailed description
The study was designed as a prospective cohort study. Consecutive patients scheduled for orthognathic surgery (OGS) conducted by the senior author at the Craniofacial Center, Department of Plastic and Reconstructive Surgery, Chang Gung Memorial Hospital between January and August 2013 were asked to participate. OGS procedures included mandibular BSSO with or without maxillary LeFort I osteotomy or genioplasty. Fifty-seven patients were enrolled. All patients received cone-beam computed tomography before surgery for intra-alveolar nerve (IAN) assessment and virtual surgery planning.
During surgery, corticotomy and osteotomy lines are modified from the Obwegeser-Dal Pont method. After corticotomy completion, a Dautrey osteotome is driven into the mandible medulla via the anterior corticotomy, keeping constant contact to the inner side of the buccal ramus cortex for the first 10mm. The osteotome, located anterior and lateral to the IAN, is then twisted with moderate force, gradually separating the proximal and distal segment cortices along the anterior opening to facilitate visualization. Possible resistance to open the cortices indicates incomplete corticotomies located in the medial cortex, or the posterior and inferior aspects of both corticotomy lines. Before the complete split, the IAN is evaluated for any exposure through the anterior opening . If the IAN is exposed or attached to the outer cortex, it can gently be replaced into the distal segment. Under visualization through the anterior opening, a straight 4 or 6 mm osteotome is then inserted lateral to and passed beyond the IAN, and then hit to split the posterior ramus cortex along the inner surface of the proximal segment to reach the posterior border.
A standardized record form was provided to all subjects before and after surgery. Gender, preoperative diagnosis and operative details were collected, including surgical plan, mandibular movement extent and concomitant surgical procedures i.e. LeFort I and genioplasty, problematic mandibular splitting and type of fixation. All BSSO procedures were divided into independent left and right sides. After successful splitting of the mandibular ramus, splitting results were categorized.
A 5-point scale self-assessment questionnaire was used during the routine follow up visits to evaluate IAN neurosensory disturbance (NSD) after the BSSO procedure. The subjective neurosensory status evaluation was performed preoperatively, one week, 6 and 12 months postoperatively or until normal sensation returned.
- Being tested
- bilateral sagittal split osteotomy
- Keywords
- inferior alveolar nerve, neurosensory disturbance, bilateral sagittal spilt osteotomy, mandibular surgery, neurosensory function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bilateral sagittal split osteotomyProcedure or surgery
Also called bilateral ramus sagittal split osteotomy
surgical technique to split the mandibular ramus through three osteotomy lines on the medial-cranial, buccal-caudal and anterior surface to facilitate a split of the posterior border of the mandible without injury of the inferior alveolar nerve
| Study group | Role | What they receive |
|---|---|---|
| Surgical intervention | Experimental | Patients receiving our modified bilateral sagittal split osteotomy procedure during orthognathic surgery, "intervention arm" in prospective cohort study Receives: Procedure: bilateral sagittal split osteotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of NSD 12 months postoperatively in relation to IAN exposure during surgery
For every patient, the incidence of IAN exposure is recorded. The incidence of NSD is evaluated 12 months after the procedure. The relation and statistical significance is documented with Chi-square-test.
Measured: preoperative to at least 12 months after surgery or return of normal sensation; if no return of normal sensation, reevaluation after another 3 months with computer tomography and clinical exam
Secondary outcomes (3)
Longitudinal incidence of NSD in relation to gender, age, affected side, preexisting deformity, third molar extraction and genioplasty
Subanalysis of the patients in the above mentioned fashion. Clinical evaluation of neurosensory disturbance level of the intraalveolar nerve is carried out with self-assessment questionnaire grading as 1. Affected mandibular side is completely numb, 2. Affected mandibular side is numb with almost no sensation, 3. Affected mandibular side sensation is reduced with some intact sensation, 4. Affected mandibular side has almost normal sensation, 5. Completely normal sensation, no change at all. Subjective neurosensory status evaluation is performed preoperatively, one week, 6 and 12 months postoperatively or until normal sensation return, and absence of neurosensory disturbance was defined with the cutoff at 5 points in the scale. Neurosensory disturbance scores of 1 to 4 are considered abnormal. If the disturbance persists over 12 months, computed tomography and clinical evaluation are performed after additional 3 months.
Measured: preoperative to at least 12 months after surgery or return of normal sensation; if no return of normal sensation, reevaluation after another 3 months with computer tomography and clinical exam
Longitudinal incidence of NSD in relation to split type during surgery
Subanalysis of the patients in the above mentioned fashion. After blinding and light touch on the areas with an 18 gauge needle, participants were asked to choose a score for each one of the tested sites from a scale of 1 to 5. The lowest score was rated as the neurosensory status score at the time of evaluation. Subjective neurosensory status evaluation is performed preoperatively, one week, 6 and 12 months postoperatively or until normal sensation return, and absence of neurosensory disturbance was defined with the cutoff at 5 points in the scale. Neurosensory disturbance scores of 1 to 4 are considered abnormal. If the disturbance persists over 12 months, computed tomography and clinical evaluation are performed after additional 3 months.
Measured: preoperative to at least 12 months after surgery or return of normal sensation; if no return of normal sensation, reevaluation after another 3 months with computer tomography and clinical exam
Longitudinal incidence of NSD in relation to IAN exposure
Subanalysis of the patients in the above mentioned fashion. After blinding and light touch on the areas with an 18 gauge needle, participants were asked to choose a score for each one of the tested sites from a scale of 1 to 5. The lowest score was rated as the neurosensory status score at the time of evaluation. Subjective neurosensory status evaluation is performed preoperatively, one week, 6 and 12 months postoperatively or until normal sensation return, and absence of neurosensory disturbance was defined with the cutoff at 5 points in the scale. Neurosensory disturbance scores of 1 to 4 are considered abnormal. If the disturbance persists over 12 months, computed tomography and clinical evaluation are performed after additional 3 months.
Measured: preoperative to at least 12 months after surgery or return of normal sensation; if no return of normal sensation, reevaluation after another 3 months with computer tomography and clinical exam
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2015 (estimated)
- Study startJan 2013
- Primary completionDec 2014
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Neurosensory Function of Inferior Alveolar NerveStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lun-Jou Lo, MD, Study director, Chairman, Department of Surgery, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02634840
- Sponsor's protocol ID
- CMRPG381601-3
- Other IDs
- CGMH-IRB-101-5264B
- Status last verified
- Dec 2015
- First submitted
- 16 Dec 2015
- Last updated
- 6 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Obwegeser HL. Orthognathic surgery and a tale of how three procedures came to be: a letter to the next generations of surgeons. Clin Plast Surg. 2007 Jul;34(3):331-55. doi: 10.1016/j.cps.2007.05.014.
PubMed 17692696Westermark A, Bystedt H, von Konow L. Inferior alveolar nerve function after sagittal split osteotomy of the mandible: correlation with degree of intraoperative nerve encounter and other variables in 496 operations. Br J Oral Maxillofac Surg. 1998 Dec;36(6):429-33. doi: 10.1016/s0266-4356(98)90458-2.
PubMed 9881784Ylikontiola L, Kinnunen J, Oikarinen K. Factors affecting neurosensory disturbance after mandibular bilateral sagittal split osteotomy. J Oral Maxillofac Surg. 2000 Nov;58(11):1234-9; discussion 1239-40. doi: 10.1053/joms.2000.16621.
PubMed 11078134Kane AA, Lo LJ, Chen YR, Hsu KH, Noordhoff MS. The course of the inferior alveolar nerve in the normal human mandibular ramus and in patients presenting for cosmetic reduction of the mandibular angles. Plast Reconstr Surg. 2000 Oct;106(5):1162-74; discussion 1175-6. doi: 10.1097/00006534-200010000-00029.
PubMed 11039388Hanzelka T, Foltan R, Pavlikova G, Horka E, Sedy J. The role of intraoperative positioning of the inferior alveolar nerve on postoperative paresthesia after bilateral sagittal split osteotomy of the mandible: prospective clinical study. Int J Oral Maxillofac Surg. 2011 Sep;40(9):901-6. doi: 10.1016/j.ijom.2011.04.002. Epub 2011 May 13.
PubMed 21570811Colella G, Cannavale R, Vicidomini A, Lanza A. Neurosensory disturbance of the inferior alveolar nerve after bilateral sagittal split osteotomy: a systematic review. J Oral Maxillofac Surg. 2007 Sep;65(9):1707-15. doi: 10.1016/j.joms.2007.05.009.
PubMed 17719387Agbaje JO, Salem AS, Lambrichts I, Jacobs R, Politis C. Systematic review of the incidence of inferior alveolar nerve injury in bilateral sagittal split osteotomy and the assessment of neurosensory disturbances. Int J Oral Maxillofac Surg. 2015 Apr;44(4):447-51. doi: 10.1016/j.ijom.2014.11.010. Epub 2014 Dec 9.
PubMed 25496848
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Modified Technique of Mandibular Ramus Sagittal Split Osteotomy for Prevention of Inferior Alveolar Nerve Injury: A Prospective Cohort Study and Outcome Assessment
- ClinicalTrials.gov ID
- NCT02634840
- Acronym / sponsor ID
- CMRPG381601-3
- Keywords
- inferior alveolar nerve, neurosensory disturbance, bilateral sagittal spilt osteotomy, mandibular surgery, neurosensory function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 18 Dec 2015 (estimated)
- 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.
Several technical modifications based on the anatomical position of the neurovascular bundle and its bony mandibular canal have been developed, aiming to prevent injury to the intraalveolar nerve We hypothesized that the incidence of neurosensory disturbance (NSD) should be reduced using our bilateral sagittal split osteotomy (BSSO) technique, because direct intra-alveolar nerve injury can be avoided. The aim of this study was to introduce our modified BSSO technique and evaluate the subsequent incidence of postoperative neurosensory disturbance of the IAN.
Detailed description
The study was designed as a prospective cohort study. Consecutive patients scheduled for orthognathic surgery (OGS) conducted by the senior author at the Craniofacial Center, Department of Plastic and Reconstructive Surgery, Chang Gung Memorial Hospital between January and August 2013 were asked to participate. OGS procedures included mandibular BSSO with or without maxillary LeFort I osteotomy or genioplasty. Fifty-seven patients were enrolled. All patients received cone-beam computed tomography before surgery for intra-alveolar nerve (IAN) assessment and virtual surgery planning.
During surgery, corticotomy and osteotomy lines are modified from the Obwegeser-Dal Pont method. After corticotomy completion, a Dautrey osteotome is driven into the mandible medulla via the anterior corticotomy, keeping constant contact to the inner side of the buccal ramus cortex for the first 10mm. The osteotome, located anterior and lateral to the IAN, is then twisted with moderate force, gradually separating the proximal and distal segment cortices along the anterior opening to facilitate visualization. Possible resistance to open the cortices indicates incomplete corticotomies located in the medial cortex, or the posterior and inferior aspects of both corticotomy lines. Before the complete split, the IAN is evaluated for any exposure through the anterior opening . If the IAN is exposed or attached to the outer cortex, it can gently be replaced into the distal segment. Under visualization through the anterior opening, a straight 4 or 6 mm osteotome is then inserted lateral to and passed beyond the IAN, and then hit to split the posterior ramus cortex along the inner surface of the proximal segment to reach the posterior border.
A standardized record form was provided to all subjects before and after surgery. Gender, preoperative diagnosis and operative details were collected, including surgical plan, mandibular movement extent and concomitant surgical procedures i.e. LeFort I and genioplasty, problematic mandibular splitting and type of fixation. All BSSO procedures were divided into independent left and right sides. After successful splitting of the mandibular ramus, splitting results were categorized.
A 5-point scale self-assessment questionnaire was used during the routine follow up visits to evaluate IAN neurosensory disturbance (NSD) after the BSSO procedure. The subjective neurosensory status evaluation was performed preoperatively, one week, 6 and 12 months postoperatively or until normal sensation returned.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgical intervention | Experimental | Procedure: bilateral sagittal split osteotomyPatients receiving our modified bilateral sagittal split osteotomy procedure during orthognathic surgery, "intervention arm" in prospective cohort study |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- patients receiving mandibular bilateral sagittal split osteotomy during orthognathic surgery with normal preoperative intraalveolar nerve function
- patients with cleft lip/palate or hemifacial microsomia were also included
Key exclusion criteria (1 listed)
- craniofacial syndromic condition, abnormal psychomotor development or previous history of mandibular fracture
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 |
|---|---|---|
| bilateral sagittal split osteotomyAlso: bilateral ramus sagittal split osteotomysurgical technique to split the mandibular ramus through three osteotomy lines on the medial-cranial, buccal-caudal and anterior surface to facilitate a split of the posterior border of the mandible without injury of the inferior alveolar nerve | Procedure or surgery | Surgical intervention |
Primary outcome
Incidence of NSD 12 months postoperatively in relation to IAN exposure during surgery
Time frame: preoperative to at least 12 months after surgery or return of normal sensation; if no return of normal sensation, reevaluation after another 3 months with computer tomography and clinical exam
For every patient, the incidence of IAN exposure is recorded. The incidence of NSD is evaluated 12 months after the procedure. The relation and statistical significance is documented with Chi-square-test.
3 secondary outcomes
Longitudinal incidence of NSD in relation to gender, age, affected side, preexisting deformity, third molar extraction and genioplasty
Time frame: preoperative to at least 12 months after surgery or return of normal sensation; if no return of normal sensation, reevaluation after another 3 months with computer tomography and clinical exam
Longitudinal incidence of NSD in relation to split type during surgery
Time frame: preoperative to at least 12 months after surgery or return of normal sensation; if no return of normal sensation, reevaluation after another 3 months with computer tomography and clinical exam
Longitudinal incidence of NSD in relation to IAN exposure
Time frame: preoperative to at least 12 months after surgery or return of normal sensation; if no return of normal sensation, reevaluation after another 3 months with computer tomography and clinical exam
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 6 Jan 2016.
- Background: PubMed 17692696Obwegeser HL. Orthognathic surgery and a tale of how three procedures came to be: a letter to the next generations of surgeons. Clin Plast Surg. 2007 Jul;34(3):331-55. doi: 10.1016/j.cps.2007.05.014.
- Background: PubMed 9881784Westermark A, Bystedt H, von Konow L. Inferior alveolar nerve function after sagittal split osteotomy of the mandible: correlation with degree of intraoperative nerve encounter and other variables in 496 operations. Br J Oral Maxillofac Surg. 1998 Dec;36(6):429-33. doi: 10.1016/s0266-4356(98)90458-2.
- Background: PubMed 11078134Ylikontiola L, Kinnunen J, Oikarinen K. Factors affecting neurosensory disturbance after mandibular bilateral sagittal split osteotomy. J Oral Maxillofac Surg. 2000 Nov;58(11):1234-9; discussion 1239-40. doi: 10.1053/joms.2000.16621.
- Background: PubMed 11039388Kane AA, Lo LJ, Chen YR, Hsu KH, Noordhoff MS. The course of the inferior alveolar nerve in the normal human mandibular ramus and in patients presenting for cosmetic reduction of the mandibular angles. Plast Reconstr Surg. 2000 Oct;106(5):1162-74; discussion 1175-6. doi: 10.1097/00006534-200010000-00029.
- Background: PubMed 21570811Hanzelka T, Foltan R, Pavlikova G, Horka E, Sedy J. The role of intraoperative positioning of the inferior alveolar nerve on postoperative paresthesia after bilateral sagittal split osteotomy of the mandible: prospective clinical study. Int J Oral Maxillofac Surg. 2011 Sep;40(9):901-6. doi: 10.1016/j.ijom.2011.04.002. Epub 2011 May 13.
- Background: PubMed 17719387Colella G, Cannavale R, Vicidomini A, Lanza A. Neurosensory disturbance of the inferior alveolar nerve after bilateral sagittal split osteotomy: a systematic review. J Oral Maxillofac Surg. 2007 Sep;65(9):1707-15. doi: 10.1016/j.joms.2007.05.009.
- Background: PubMed 25496848Agbaje JO, Salem AS, Lambrichts I, Jacobs R, Politis C. Systematic review of the incidence of inferior alveolar nerve injury in bilateral sagittal split osteotomy and the assessment of neurosensory disturbances. Int J Oral Maxillofac Surg. 2015 Apr;44(4):447-51. doi: 10.1016/j.ijom.2014.11.010. Epub 2014 Dec 9.
- Individual participant dataSharing planned: No
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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.
Lun-Jou Lo, MD study director
Chairman, Department of Surgery, Chang Gung Memorial Hospital
Questions about this trial
What is this clinical trial studying?
A study testing bilateral sagittal split osteotomy in people with Neurosensory Function of Inferior Alveolar Nerve, run by Chang Gung Memorial Hospital.
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 2 inclusion and 1 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 6 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Incidence of NSD 12 months postoperatively in relation to IAN exposure during surgery (time frame: preoperative to at least 12 months after surgery or return of normal sensation; if no return of normal sensation, reevaluation after another 3 months with computer tomography and clinical exam). 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 NCT02634840, which also lists 7 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 6 Jan 2016.