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Status unknownNCT01586598Updated Apr 27, 2012

Sensory Retraining Facilitates Sensory Recovery After Mandibular Nerve Injury

An interventional study of sensory retraining protocol in Injury of Trigeminal Nerve, Surgery and Mandibular Prognathism, sponsored by Chang Gung Memorial Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2012-04-27.

Sponsored by Chang Gung Memorial Hospital · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Apr 2012), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
01

Study summary

The purpose of this study is to determine whether sensory retraining exercise could improve lip numbness caused by bilateral sagittal split of mandible.

Read the detailed description

The study is a prospective randomized controlled trial. The patients receiving bilateral sagittal split osteotomy and having lip numbness or paraesthesia will be included in this study. 80 patients will be included and randomized into two groups and there are 40 patients in each group. The control group is to maintain follow up in clinic and do not receive any sensory retraining exercise. The experimental group is requested to perform sensory retraining at home by themselves.

02

Conditions studied

  • Injury of Trigeminal Nerve
  • Surgery
  • Mandibular Prognathism

Keywords

  • Mandibular Nerve
  • Orthognathic Surgery
  • Sagittal Split Osteotomy
  • Sensory Retraining
03

In context

Malocclusion, Angle Class III

59 studies on the registry are indexed under Malocclusion, Angle Class III; 13 are open to participants now.

This study's planned enrollment of 80 is above the median of 32 across 54 interventional studies indexed under Malocclusion, Angle Class III.

Browse Malocclusion, Angle Class III studies →

Lead sponsor

Chang Gung Memorial Hospital is the lead sponsor of 1,091 studies on the registry; 237 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Taiwanese adult (18-40 y/o)
  2. Developmental dentofacial disharmony (Class III)
  3. Patients received orthognathic surgery (BSSO alone or with maxillary procedure)

Exclusion criteria

Exclusion Criteria:

  1. Medical condition associated with systemic neuropathy
  2. Unwilling to sign informed consent
  3. Congenital anomaly or acute trauma affecting the face
  4. Previous facial surgery
  5. Positive pain sensation at first week of post-surgery
  6. Altered sensation before OGS as numbness or unusual feeling
  7. Cleft lip and palate
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
80 participants (estimated)

Study arms

  • No intervention
    control group

    No intervention will be given to this control group. Spontaneous recovery of mandibular nerve will be assessed for sensory function.

  • Experimental
    sensory retraining group

    Sensory retraining protocol will be applied this group. Any facilitation of sensory function in mandibular nerve will be assessed.

    Behavioral: sensory retraining protocol

Interventions

  • Behavioralsensory retraining protocol

    1. within one month after the surgery: facial massage and physical stimulation over lower face and lip, four times (20 minutes each time) a day 2. one to three months after the surgery: brush and physical stimulation over lower face and lip, four times (20 minutes each time) a day 3. three to six months after the surgery: brush, pin and physical stimulation over lower face and lip, four times (20 minutes each time) a day

    Also known as: sensory retraining

06

What researchers measure

Primary outcomes

  1. sensory function test

    The sensory function evaluation include objective and subjective examinations as the followings: 1. Questionnaire 2. Visual analogue scale (VAS) 3. Two-point discrimination (2PD) 4. Pain detection threshold (PD) tests 5. Touch sensory threshold

    Time frame: one year after surgery

07

Study locations

1 site
  • Chang Gung Memorial Hospital
    Taipei, Taiwan 10507, Taiwan
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Apr 2012, a primary completion of Sep 2014 and a completion of Sep 2015. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 15, 2012
First posted
Apr 27, 2012
Start
Apr 2012
Primary completionEst.
Sep 2014
CompletionEst.
Sep 2015
Last update
Apr 27, 2012
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 27, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01586598
Responsible party
Sponsor
First posted
Apr 27, 2012
Start date
Apr 2012
Primary completion
Sep 2014 (estimated)
Completion
Sep 2015 (estimated)
Last update
Apr 27, 2012

Study contacts

Chiung Shing Huang, PhD, DDS
principal investigator · Chang Gung Memorial Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2012. You cannot join it, but the record below documents what was studied.

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