Sensory DeficitNCT03995511

Neurosensory Deficit of Inferior Alveolar Nerve Following Mandibular Orthognathic Surgery.

A study testing Bilateral Sagittal Split Osteotomy in people with Sensory Deficit, run by Riyadh Colleges of Dentistry and Pharmacy at 1 site in Saudi Arabia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for: Sensory Deficit
What is being tested?: Bilateral Sagittal Split Osteotomy
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteSaudi Arabia
Study dates: 15 Oct 2019to 17 Dec 2020
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 40 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Patients with lower jaw deformity requiring bilateral sagittal split osteotomy

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Saudi Arabia1 site

Riyadh Elm University
Riyadh, 11681

Other trials in Saudi Arabia

About this study

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

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.

Conditions: Sensory Deficit
Being tested: Bilateral Sagittal Split Osteotomy
Keywords: Sensory deficit, Orthognathic surgery, Mandibular osteotomy, Inferior alveolar nerve

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Bilateral Sagittal Split OsteotomyProcedure or surgery
Surgical correction of lower jaw deformity by performing bilateral intraoral sagittal osteotomy of the mandible under general anesthesia.

Study groups in NCT03995511
Study group	Role	What they receive
Bilateral sagittal split	Experimental	Not described Receives: Procedure: Bilateral Sagittal Split Osteotomy

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Three months after the surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Oct 201917 Dec 2020

First posted24 Jun 2019
Study start15 Oct 2019
Primary completion30 Sep 2020
Study completion17 Dec 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Sensory DeficitStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03995511
Sponsor's protocol ID: FPGRP/43836005/325
Status last verified: Sep 2022
First submitted: 20 Jun 2019
Last updated: 27 Sep 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Translation and Cultural Adaptation of the Erasmus Modified Nottingham Sensory Assessment Scale for the Lower Limb in Acquired Brain Injury Into French
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All Sensory Deficit trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Neurosensory Deficit of Inferior Alveolar Nerve Following Mandibular Orthognathic Surgery. A Prospective Longitudinal Clinical Trial.
ClinicalTrials.gov ID: NCT03995511
Acronym / sponsor ID: FPGRP/43836005/325
Conditions: Sensory Deficit
Keywords: Sensory deficit, Orthognathic surgery, Mandibular osteotomy, Inferior alveolar nerve
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Riyadh Colleges of Dentistry and PharmacyUniversity, hospital or other
Collaborators: King Saud Medical City
Study start: 15 Oct 2019 (actual)
Primary completion: 30 Sep 2020 (actual)
Study completion: 17 Dec 2020 (actual)
First posted: 24 Jun 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Bilateral sagittal split	Experimental	Procedure: Bilateral Sagittal Split Osteotomy

Who may qualify

Ages: 18 to 40 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

Patients with lower jaw deformity requiring bilateral sagittal split osteotomy

Key exclusion criteria (7 listed)

Medically compromised patients
Previous neurosurgical procedure
Patients on chronic medications
Patients with a mental or psychiatric disorder
Pregnant and lactating female

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Bilateral Sagittal Split OsteotomySurgical correction of lower jaw deformity by performing bilateral intraoral sagittal osteotomy of the mandible under general anesthesia.	Procedure or surgery	Bilateral sagittal split

Primary outcome

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.
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.
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.
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
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
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
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.
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.
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.
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.
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.
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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2022.

Related trials for Sensory Deficit

Recruiting
Walking Sensation Study
Aging, Sensory Deficit
RecruitingPhase 2
Efficacy of Reboxetine and Methylphenidate Treatment on Attentional, Sensory and Emotional Dysregulation in Adults With PTSD
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Recruiting
Patients At Risk for Sensory Screening (HPARSS) to Enhance Sensory Deficit Screening in Childhood Cancer Survivors
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Not yet recruitingObservational study
Translation and Cultural Adaptation of the Erasmus Modified Nottingham Sensory Assessment Scale for the Lower Limb in Acquired Brain Injury Into French
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ra'ed G Salma study director

Riyadh Elm University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Bilateral Sagittal Split Osteotomy in people with Sensory Deficit, run by Riyadh Colleges of Dentistry and Pharmacy at 1 site in Saudi Arabia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Light touch sensation first week (time frame: One week after the surgery). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03995511.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2022.