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NCT Number: NCT03995511

Neurosensory Deficit of Inferior Alveolar Nerve Following Mandibular Orthognathic Surgery.

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.

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Key information

Conditions

Sensory Deficit

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Riyadh Elm University

Riyadh, 11681, Saudi Arabia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bilateral sagittal split osteotomy

Procedure

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

Primary outcomes

  1. Light touch sensation first week

    Time frame: 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.

  2. Light touch sensation first month

    Time frame: 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.

  3. Light touch sensation three months

    Time frame: 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.

  4. Pinprick sensation first week

    Time frame: 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

  5. Pinprick sensation first month

    Time frame: 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

  6. Pinprick sensation three months

    Time frame: 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

  7. Static two points discrimination first week

    Time frame: 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.

  8. Static two points discrimination first month

    Time frame: 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.

  9. Static two points discrimination three months

    Time frame: 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.

  10. Warm/cold test first week

    Time frame: 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.

  11. Warm/cold test first month

    Time frame: 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.

  12. Warm/cold test three months

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Riyadh Colleges of Dentistry and Pharmacy

Other

Collaborators

  • King Saud Medical City

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jun 24, 2019
Registry last updated
Sep 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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