Neurosensory Deficit of Inferior Alveolar Nerve Following Mandibular Orthognathic Surgery.
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- Light touch sensation first week [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
- Patients with lower jaw deformity requiring bilateral sagittal split osteotomy
Exclusion Criteria:
-
Medically compromised patients
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Previous neurosurgical procedure
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Patients on chronic medications
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Patients with a mental or psychiatric disorder
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Pregnant and lactating female
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Previous neurosensory deficit due to trauma, pathology, or surgery
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Patients with facial pain disorders including trigeminal neuralgia, temporomandibular disorder, or atypical facial pain
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Riyadh Elm University | Riyadh | Saudi Arabia | 11681 |
Sponsors and Collaborators
- Riyadh Colleges of Dentistry and Pharmacy
- King Saud Medical City
Investigators
- Study Director: Ra'ed G Salma, Riyadh Elm University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- FPGRP/43836005/325