NCT03995511

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 20, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 24, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

October 15, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 17, 2020

Completed
Last Updated

September 27, 2022

Status Verified

September 1, 2022

Enrollment Period

12 months

First QC Date

June 20, 2019

Last Update Submit

September 25, 2022

Conditions

Sensory Deficit

Keywords

Sensory deficitOrthognathic surgeryMandibular osteotomyInferior alveolar nerve

Outcome Measures

Primary Outcomes (12)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Study Arms (1)

Bilateral sagittal split

EXPERIMENTAL
Procedure: Bilateral Sagittal Split Osteotomy

Interventions

Bilateral Sagittal Split OsteotomyPROCEDURE

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

Bilateral sagittal split

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with lower jaw deformity requiring bilateral sagittal split osteotomy

You may not qualify if:

  • 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 the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riyadh Elm University

Riyadh, 11681, Saudi Arabia

Location

Study Officials

  • Ra'ed G Salma

    Riyadh Elm University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 20, 2019

First Posted

June 24, 2019

Study Start

October 15, 2019

Primary Completion

September 30, 2020

Study Completion

December 17, 2020

Last Updated

September 27, 2022

Record last verified: 2022-09

Locations

SA(1)