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Neurosensory Deficit of Inferior Alveolar Nerve Following Mandibular Orthognathic Surgery.
This clinical study investigates the sensation deficit in the lower lip and chin area after surgical correction of lower jaw deformity.
The primary null hypothesis is: Lower jaw osteotomy cause no sensory deficit in the inferior alveolar nerve.
The secondary null hypothesis is: Concurrent genioplasty with sagittal split does not increase the risk of sensory deficit in the inferior alveolar nerve.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Sensory Deficit | Procedure: Bilateral Sagittal Split Osteotomy | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 40 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Supportive Care |
| Official Title: | Neurosensory Deficit of Inferior Alveolar Nerve Following Mandibular Orthognathic Surgery. A Prospective Longitudinal Clinical Trial. |
| Actual Study Start Date : | October 15, 2019 |
| Estimated Primary Completion Date : | August 2020 |
| Estimated Study Completion Date : | September 2020 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: Bilateral sagittal split |
Procedure: Bilateral Sagittal Split Osteotomy
Surgical correction of lower jaw deformity by performing bilateral intraoral sagittal osteotomy of the mandible under general anesthesia.
|
- Light touch sensation first week [ Time Frame: One week after the surgery ]
Light touch sensation will be measured using cotton wisp applied to the chin and lower lip area divided into four quadrants: upper right, upper left, lower right, and lower left.
The cotton wisp will be in touch with skin in the four quadrants and will be moved in four directions for each quadrant.
The score will be recorded as 0 = No response to stimuli, 1= serious perception loss, 2 = hardly perceive sensation, 3 = perceive touch sensation at a lower degree than preoperative, and 4 = normal sensation.
- Light touch sensation first month [ Time Frame: One month after the surgery ]
Light touch sensation will be measured using cotton wisp applied to the chin and lower lip area divided into four quadrants: upper right, upper left, lower right, and lower left.
The cotton wisp will be in touch with skin in the four quadrants and will be moved in four directions for each quadrant.
The score will be recorded as 0 = No response to stimuli, 1= serious perception loss, 2 = hardly perceive sensation, 3 = perceive touch sensation at a lower degree than preoperative, and 4 = normal sensation.
- Light touch sensation three months [ Time Frame: Three months after the surgery ]
Light touch sensation will be measured using cotton wisp applied to the chin and lower lip area divided into four quadrants: upper right, upper left, lower right, and lower left.
The cotton wisp will be in touch with skin in the four quadrants and will be moved in four directions for each quadrant.
The score will be recorded as 0 = No response to stimuli, 1= serious perception loss, 2 = hardly perceive sensation, 3 = perceive touch sensation at a lower degree than preoperative, and 4 = normal sensation.
- Pinprick sensation first week [ Time Frame: One week after the surgery ]A tip of sharp dental explorer will be used to measure the pinprick sensation applied to the chin and lower lip area divided into four quadrants: upper right, upper left, lower right, and lower left. The measurement will be recorded as a positive or negative response
- Pinprick sensation first month [ Time Frame: One month after the surgery ]A tip of sharp dental explorer will be used to measure the pinprick sensation applied to the chin and lower lip area divided into four quadrants: upper right, upper left, lower right, and lower left. The measurement will be recorded as a positive or negative response
- Pinprick sensation three months [ Time Frame: Three months after the surgery ]A tip of sharp dental explorer will be used to measure the pinprick sensation applied to the chin and lower lip area divided into four quadrants: upper right, upper left, lower right, and lower left. The measurement will be recorded as a positive or negative response
- Static two points discrimination first week [ Time Frame: One week after the surgery ]
A Vernier caliper will be used to measure static two-point discrimination applied to the chin and lower lip area divided into four quadrants: upper right, upper left, lower right, and lower left. Instrument spikes of the caliper will be set open on different separation distances.
The score will be recorded as 0 = more than 15 mm, 1 = 10-15 mm, 2 = 9-10 mm, 3 = 7-9 mm, 4 = 6-7 mm, 5 = equal or less than 5 mm.
- Static two points discrimination first month [ Time Frame: One month after the surgery ]
A Vernier caliper will be used to measure static two-point discrimination applied to the chin and lower lip area divided into four quadrants: upper right, upper left, lower right, and lower left. Instrument spikes of the caliper will be set open on different separation distances.
The score will be recorded as 0 = more than 15 mm, 1 = 10-15 mm, 2 = 9-10 mm, 3 = 7-9 mm, 4 = 6-7 mm, 5 = equal or less than 5 mm.
- Static two points discrimination three months [ Time Frame: Three months after the surgery ]
A Vernier caliper will be used to measure static two-point discrimination applied to the chin and lower lip area divided into four quadrants: upper right, upper left, lower right, and lower left. Instrument spikes of the caliper will be set open on different separation distances.
The score will be recorded as 0 = more than 15 mm, 1 = 10-15 mm, 2 = 9-10 mm, 3 = 7-9 mm, 4 = 6-7 mm, 5 = equal or less than 5 mm.
- Warm/cold test first week [ Time Frame: One week after the surgery ]
The measure will be preformed using test tube filled with hot water at temperature 45-50 degrees Celsius, and an ice cube applied to the chin and lower lip area divided into four quadrants: upper right, upper left, lower right, and lower left.
The measurement will be recorded as a positive or negative response.
- Warm/cold test first month [ Time Frame: One month after the surgery ]
The measure will be preformed using test tube filled with hot water at temperature 45-50 degrees Celsius, and an ice cube applied to the chin and lower lip area divided into four quadrants: upper right, upper left, lower right, and lower left.
The measurement will be recorded as a positive or negative response.
- Warm/cold test three months [ Time Frame: Three months after the surgery ]
The measure will be preformed using test tube filled with hot water at temperature 45-50 degrees Celsius, and an ice cube applied to the chin and lower lip area divided into four quadrants: upper right, upper left, lower right, and lower left.
The measurement will be recorded as a positive or negative response.
| Ages Eligible for Study: | 18 Years to 40 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Patients with lower jaw deformity requiring bilateral sagittal split osteotomy
Exclusion Criteria:
- Medically compromised patients
- Previous neurosurgical procedure
- Patients on chronic medications
- Patients with a mental or psychiatric disorder
- Pregnant and lactating female
- Previous neurosensory deficit due to trauma, pathology, or surgery
- Patients with facial pain disorders including trigeminal neuralgia, temporomandibular disorder, or atypical facial pain
| Contact: Ra'ed G Salma | +966567197272 | rsalma@yahoo.com |
| Saudi Arabia | |
| Riyadh Elm University | Recruiting |
| Riyadh, Saudi Arabia, 11681 | |
| Contact: Ashraf Kamel, MD +966592606170 ashraf.kamel@riyadh.edu.sa | |
| Principal Investigator: Ra'ed G Salma | |
| Sub-Investigator: Abdullah Hanfesh | |
| Study Director: | Ra'ed G Salma | Riyadh Elm University |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 20, 2019 | ||||
| First Posted Date ICMJE | June 24, 2019 | ||||
| Last Update Posted Date | March 10, 2020 | ||||
| Actual Study Start Date ICMJE | October 15, 2019 | ||||
| Estimated Primary Completion Date | August 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
|
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Neurosensory Deficit of Inferior Alveolar Nerve Following Mandibular Orthognathic Surgery. | ||||
| Official Title ICMJE | Neurosensory Deficit of Inferior Alveolar Nerve Following Mandibular Orthognathic Surgery. A Prospective Longitudinal Clinical Trial. | ||||
| Brief Summary |
This clinical study investigates the sensation deficit in the lower lip and chin area after surgical correction of lower jaw deformity. The primary null hypothesis is: Lower jaw osteotomy cause no sensory deficit in the inferior alveolar nerve. The secondary null hypothesis is: Concurrent genioplasty with sagittal split does not increase the risk of sensory deficit in the inferior alveolar nerve. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Supportive Care |
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| Condition ICMJE | Sensory Deficit | ||||
| Intervention ICMJE | Procedure: Bilateral Sagittal Split Osteotomy
Surgical correction of lower jaw deformity by performing bilateral intraoral sagittal osteotomy of the mandible under general anesthesia.
|
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| Study Arms ICMJE | Experimental: Bilateral sagittal split
Intervention: Procedure: Bilateral Sagittal Split Osteotomy
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE |
40 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | September 2020 | ||||
| Estimated Primary Completion Date | August 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 40 Years (Adult) | ||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | Saudi Arabia | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03995511 | ||||
| Other Study ID Numbers ICMJE | FPGRP/43836005/325 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||
| Responsible Party | Ra'ed Salma, Riyadh Colleges of Dentistry and Pharmacy | ||||
| Study Sponsor ICMJE | Riyadh Colleges of Dentistry and Pharmacy | ||||
| Collaborators ICMJE | King Saud Medical City | ||||
| Investigators ICMJE |
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| PRS Account | Riyadh Colleges of Dentistry and Pharmacy | ||||
| Verification Date | March 2020 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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