Neurosensory Deficit of Inferior Alveolar Nerve Following Mandibular Orthognathic Surgery.

Not Applicable

Completed

• Conditions: Sensory Deficit
• Interventions: Procedure: Bilateral Sagittal Split Osteotomy

• Registration Number: NCT03995511
• Lead Sponsor: Riyadh Colleges of Dentistry and Pharmacy

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-06-20
• Study First Submitted QC: 2019-06-20
• Study First Posted: 2019-06-24
• Study Start: 2019-10-15
• Primary Completion: 2020-09-30
• Study Completion: 2020-12-17
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-25
• Last Update Posted: 2022-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bilateral sagittal split	Bilateral Sagittal Split Osteotomy	-

Primary Outcome Measures

Name	Time	Method
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.
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 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
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.
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 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.
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.
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 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.

Trial Locations

Locations (1)

Riyadh Elm University; 🇸🇦 Riyadh, Saudi Arabia