Third Division of Fifth Cranial Nerve DisorderNCT01875965
IAN Injury After BSSO in Oral Clefts
An observational study of Third Division of Fifth Cranial Nerve Disorder, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Background and Purposes: Orthognathic surgery is necessary in more than 25% of patients with cleft lip and palate (CLP) to correct skeletal discrepancy and to obtain harmonious facial esthetics in the final phase treatment. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Third Division of Fifth Cranial Nerve Disorder
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2013to Mar 2017
- How long will I take part?
- 24 Months
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: recruit patients with nonsyndromic CLP (age, >16 for females, >18 for males), who will undergo Dal Pont type BSSO as a part of the correction of their dentofacial deformities, from Chang Gung Craniofacial Center, Taoyuan.
Who may be able to join
- patients with nonsyndromic CLP (age, >16 for females, >18 for males), who will undergo Dal Pont type BSSO as a part of the correction of their dentofacial deformities, from Chang Gung Craniofacial Center, Taoyuan.
Who cannot join
- (1) patients with history of previous BSSO or mandibular fracture; (2) patients with craniofacial anomaly; (3) patients with IAN disturbances before BSSO; (4) patients with IAN being cut or drilled at BSSO; (5) patients who are non-compliant with test or test schedule; and (6) patients who are reluctant to sign informed consent.
Trial locations and contacts
1 site in 1 country.
Yuh-Jia Hsieh, MS contact
Taiwan1 site
Chang Gung Memorial Hospital
Taoyuan
Yu-Jia Hsieh, MS, +886-3-3196200 ext. 3500
Yu-Jia Hsieh, MS
About this study
Official title: Inferior Alveolar Nerve Injury After Bilateral Sagittal Split Osteotomy in Oral Clefts
Background and Purposes: Orthognathic surgery is necessary in more than 25% of patients with cleft lip and palate (CLP) to correct skeletal discrepancy and to obtain harmonious facial esthetics in the final phase treatment. A setback of mandible by bilateral sagittal split osteotomy (BSSO) along with maxillary osteotomy is usually performed when large skeletal discrepancies or associated mandibular deformities (e.g., asymmetries, canting of the mandibular occlusal plane) are present. Although the surgical technique of BSSO is well-developed, the neurosensory disturbances of the inferior alveolar nerve (IAN) remain one of the major postoperative complications. The purpose of this study is to identify the risk factors of IAN disturbances after BSSO and in turn to help clinicians to avoid such complication and to raise the satisfaction level of patients.
Design: Prospective prognosis study. Setting: Chang Gung Craniofacial Center, Taoyuan. Patients: Two hundred Taiwanese patients with nonsyndromic CLP (age, >16 for females, >18 for males), who will undergo a BSSO as a part of the correction of their dentofacial deformities Measurements: All patients will undergo subjective (e.g., questionnaire) and objective (e.g., 2-point discrimination, light touch detection, and sharp/blunt detection) neurosensory assessments before surgery, and 1, 3, 6, 12 and 24 months after surgery. Cone beam computed tomography is performed before surgery and 1 week after surgery. Peri-operative factors including type of BSSO, extent of surgical correction, extent of split and fixation screws, concomitant genioplasty or third molar extraction are assessed. Patient-related factors including age, gender, bone quality of inferior alveolar canal are recorded as well.
Data Analysis: Univariate and multivariate analyses will be performed. Statistical significance is assumed for a p value of less than 0.05.
Read the detailed description
Orthognathic surgery is usually the final phase of treatment for patients with cleft lip and palate (CLP). More than 25% of patients with CLP develop a significant maxillary hypoplasia that requires surgical intervention, and maxillary osteotomy is, therefore, most commonly performed for these patients. If the sagittal discrepancy is too large or if there are associated mandibular deformities (e.g., asymmetries, canting of the mandibular occlusal plane), a simultaneous setback of the mandible is performed. The bilateral sagittal split osteotomy (BSSO) has become the preferred mandibular osteotomy in many centers for the treatment of mandibular deformities. Nevertheless, this treatment is known to give rise to various complications; sensory disturbance of the inferior alveolar nerve (IAN) is probably the most common one with the incidence ranging from 8% to 85%. Such sensory disturbances may affect patients' quality of life due to the difficulties in speech, eating and drinking. Patients may also complain about the inability to assess tactile stimuli such as putting on lipstick, shaving or kissing, which may lead to psychological and social issues.
IAN disturbance is believed to be caused by iatrogenic injury to the nerve including excessive nerve manipulation, nerve laceration, fixation of segments by incorrect placement of position screws, large mandibular movement and bad splits. Identification of risk factors for IAN disturbance after BSSO can help clinician to prevent it and raise the satisfaction level of patients. It is generally thought that the injury to IAN inside the mandibular ramus and body during surgery are highly correlated to variations in preoperative anatomy (ie, patient-related factors). Previous computed tomography (CT) studies have reported the anatomical variations including the thickness and length of ramus, the position and bone density of inferior alveolar nerve canal (IAC) and thickness of buccal and lingual cortical plate. However, few studies tried to identify surgery-related factors such as types of BSSO, extent of surgical correction, extent of split, concomitant genioplasty or third molar extraction. Furthermore, most of the studies were retrospective in design or had limited number of patients to conduct multivariate analysis to recognize the influences of patient- and surgery-related risk factors on IAN disturbance. Moreover, heterogeneity of the assessment timing and methods for IAN disturbance in previous studies prevented from overall assessment of the degree of IAN recovery. We therefore aim to (1) determine the incidence of IAN injury after BSSO, (2) identify the risk factors associated with such injuries, and (3) understand the consequences of such injuries including the degree of neurologic recovery by performing a prospective, longitudinal study.
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Changes in Neurosensory Function
- Subjective assessment
- Objective assessment (1)Two-point (2-PD) discrimination (2)Light touch (LT) detection (3)Sharp-and-blunt nociception test
Measured: before surgery and 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionMar 2016 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Third Division of Fifth Cranial Nerve DisorderStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yu-Fang Liao, PHD, Study director, Department of Craniofacial orthodontics, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01875965
- Sponsor's protocol ID
- 101-4707A3
- Status last verified
- Feb 2013
- First submitted
- 23 May 2013
- Last updated
- 12 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inferior Alveolar Nerve Injury After Bilateral Sagittal Split Osteotomy in Oral Clefts
- ClinicalTrials.gov ID
- NCT01875965
- Acronym / sponsor ID
- 101-4707A3
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 12 Jun 2013 (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.
Background and Purposes: Orthognathic surgery is necessary in more than 25% of patients with cleft lip and palate (CLP) to correct skeletal discrepancy and to obtain harmonious facial esthetics in the final phase treatment. A setback of mandible by bilateral sagittal split osteotomy (BSSO) along with maxillary osteotomy is usually performed when large skeletal discrepancies or associated mandibular deformities (e.g., asymmetries, canting of the mandibular occlusal plane) are present. Although the surgical technique of BSSO is well-developed, the neurosensory disturbances of the inferior alveolar nerve (IAN) remain one of the major postoperative complications. The purpose of this study is to identify the risk factors of IAN disturbances after BSSO and in turn to help clinicians to avoid such complication and to raise the satisfaction level of patients.
Design: Prospective prognosis study. Setting: Chang Gung Craniofacial Center, Taoyuan. Patients: Two hundred Taiwanese patients with nonsyndromic CLP (age, >16 for females, >18 for males), who will undergo a BSSO as a part of the correction of their dentofacial deformities Measurements: All patients will undergo subjective (e.g., questionnaire) and objective (e.g., 2-point discrimination, light touch detection, and sharp/blunt detection) neurosensory assessments before surgery, and 1, 3, 6, 12 and 24 months after surgery. Cone beam computed tomography is performed before surgery and 1 week after surgery. Peri-operative factors including type of BSSO, extent of surgical correction, extent of split and fixation screws, concomitant genioplasty or third molar extraction are assessed. Patient-related factors including age, gender, bone quality of inferior alveolar canal are recorded as well.
Data Analysis: Univariate and multivariate analyses will be performed. Statistical significance is assumed for a p value of less than 0.05.
Detailed description
Orthognathic surgery is usually the final phase of treatment for patients with cleft lip and palate (CLP). More than 25% of patients with CLP develop a significant maxillary hypoplasia that requires surgical intervention, and maxillary osteotomy is, therefore, most commonly performed for these patients. If the sagittal discrepancy is too large or if there are associated mandibular deformities (e.g., asymmetries, canting of the mandibular occlusal plane), a simultaneous setback of the mandible is performed. The bilateral sagittal split osteotomy (BSSO) has become the preferred mandibular osteotomy in many centers for the treatment of mandibular deformities. Nevertheless, this treatment is known to give rise to various complications; sensory disturbance of the inferior alveolar nerve (IAN) is probably the most common one with the incidence ranging from 8% to 85%. Such sensory disturbances may affect patients' quality of life due to the difficulties in speech, eating and drinking. Patients may also complain about the inability to assess tactile stimuli such as putting on lipstick, shaving or kissing, which may lead to psychological and social issues.
IAN disturbance is believed to be caused by iatrogenic injury to the nerve including excessive nerve manipulation, nerve laceration, fixation of segments by incorrect placement of position screws, large mandibular movement and bad splits. Identification of risk factors for IAN disturbance after BSSO can help clinician to prevent it and raise the satisfaction level of patients. It is generally thought that the injury to IAN inside the mandibular ramus and body during surgery are highly correlated to variations in preoperative anatomy (ie, patient-related factors). Previous computed tomography (CT) studies have reported the anatomical variations including the thickness and length of ramus, the position and bone density of inferior alveolar nerve canal (IAC) and thickness of buccal and lingual cortical plate. However, few studies tried to identify surgery-related factors such as types of BSSO, extent of surgical correction, extent of split, concomitant genioplasty or third molar extraction. Furthermore, most of the studies were retrospective in design or had limited number of patients to conduct multivariate analysis to recognize the influences of patient- and surgery-related risk factors on IAN disturbance. Moreover, heterogeneity of the assessment timing and methods for IAN disturbance in previous studies prevented from overall assessment of the degree of IAN recovery. We therefore aim to (1) determine the incidence of IAN injury after BSSO, (2) identify the risk factors associated with such injuries, and (3) understand the consequences of such injuries including the degree of neurologic recovery by performing a prospective, longitudinal study.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 24 Months
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- recruit patients with nonsyndromic CLP (age, >16 for females, >18 for males), who will undergo Dal Pont type BSSO as a part of the correction of their dentofacial deformities, from Chang Gung Craniofacial Center, Taoyuan.
Key inclusion criteria (1 listed)
- patients with nonsyndromic CLP (age, >16 for females, >18 for males), who will undergo Dal Pont type BSSO as a part of the correction of their dentofacial deformities, from Chang Gung Craniofacial Center, Taoyuan.
Key exclusion criteria (1 listed)
- (1) patients with history of previous BSSO or mandibular fracture; (2) patients with craniofacial anomaly; (3) patients with IAN disturbances before BSSO; (4) patients with IAN being cut or drilled at BSSO; (5) patients who are non-compliant with test or test schedule; and (6) patients who are reluctant to sign informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assessment of Changes in Neurosensory Function
Time frame: before surgery and 12 months after surgery
1. Subjective assessment 2. Objective assessment (1)Two-point (2-PD) discrimination (2)Light touch (LT) detection (3)Sharp-and-blunt nociception test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2013.
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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.
Yuh-Jia Hsieh, MS contact
Yu-Fang Liao, PHD study director
Department of Craniofacial orthodontics, Chang Gung Memorial Hospital
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 Third Division of Fifth Cranial Nerve Disorder, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 1 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: status not confirmed, as of the sponsor's last update on 12 Jun 2013. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuh-Jia Hsieh, MS (+886-3-3196200), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Changes in Neurosensory Function (time frame: before surgery and 12 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jun 2013.