Neurosensory Deficit of Inferior Alveolar Nerve Following Mandibular Orthognathic Surgery.

Sensory Deficit Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03995511
• Other study ID #: FPGRP/43836005/325
• Status: Completed
• Phase: N/A
• Start date: October 15, 2019
• Est. completion date: December 17, 2020

Study information

• Verified date: September 2022
• Source: Riyadh Colleges of Dentistry and Pharmacy
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 17, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Sensory Deficit

Intervention

Procedure:
• Bilateral Sagittal Split Osteotomy
Surgical correction of lower jaw deformity by performing bilateral intraoral sagittal osteotomy of the mandible under general anesthesia.

Locations

Country	Name	City	State
Saudi Arabia	Riyadh Elm University	Riyadh

Sponsors (2)

Lead Sponsor	Collaborator
Riyadh Colleges of Dentistry and Pharmacy	King Saud Medical City

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Light touch sensation first week	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.	One week after the surgery
Primary	Light touch sensation first month	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.	One month after the surgery
Primary	Light touch sensation three months	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.	Three months after the surgery
Primary	Pinprick sensation first week	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	One week after the surgery
Primary	Pinprick sensation first month	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	One month after the surgery
Primary	Pinprick sensation three months	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	Three months after the surgery
Primary	Static two points discrimination first week	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.	One week after the surgery
Primary	Static two points discrimination first month	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.	One month after the surgery
Primary	Static two points discrimination three months	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.	Three months after the surgery
Primary	Warm/cold test first week	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.	One week after the surgery
Primary	Warm/cold test first month	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.	One month after the surgery
Primary	Warm/cold test three months	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.	Three months after the surgery