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Neurosensory Deficit of Inferior Alveolar Nerve Following Mandibular Orthognathic Surgery.

Neurosensory Deficit of Inferior Alveolar Nerve Following Mandibular Orthognathic Surgery. A Prospective Longitudinal Clinical Trial.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03995511
Enrollment
40
Registered
2019-06-24
Start date
2019-10-15
Completion date
2020-12-17
Last updated
2022-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sensory Deficit

Keywords

Sensory deficit, Orthognathic surgery, Mandibular osteotomy, Inferior alveolar nerve

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.

Interventions

Surgical correction of lower jaw deformity by performing bilateral intraoral sagittal osteotomy of the mandible under general anesthesia.

Sponsors

King Saud Medical City
CollaboratorOTHER_GOV
Riyadh Colleges of Dentistry and Pharmacy
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Pinprick sensation first weekOne week after the surgeryA 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
Light touch sensation first weekOne week after the surgeryLight 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 monthOne month after the surgeryLight 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 monthsThree months after the surgeryLight 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 monthOne month after the surgeryA 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 monthsThree months after the surgeryA 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 weekOne week after the surgeryA 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 monthOne month after the surgeryA 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 monthsThree months after the surgeryA 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 weekOne week after the surgeryThe 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 monthOne month after the surgeryThe 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 monthsThree months after the surgeryThe 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.

Countries

Saudi Arabia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026