Injury of Trigeminal NerveNCT01586598
Sensory Retraining Facilitates Sensory Recovery After Mandibular Nerve Injury
A study testing sensory retraining protocol in people with Injury of Trigeminal Nerve and Surgery, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Injury of Trigeminal Nerve, Surgery, Mandibular Prognathism
- What is being tested?
- sensory retraining protocol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2012to Sep 2015
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Taiwanese adult (18-40 y/o)
- Developmental dentofacial disharmony (Class III)
- Patients received orthognathic surgery (BSSO alone or with maxillary procedure)
Who cannot join
- Medical condition associated with systemic neuropathy
- Unwilling to sign informed consent
- Congenital anomaly or acute trauma affecting the face
- Previous facial surgery
- Positive pain sensation at first week of post-surgery
- Altered sensation before OGS as numbness or unusual feeling
- Cleft lip and palate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sensory Retraining Exercise Facilitates Sensory Recovery After Bilateral Sagittal Split Osteotomy - a Randomized Controlled Trial
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.
- Conditions
- Injury of Trigeminal Nerve, Surgery, Mandibular Prognathism
- Being tested
- sensory retraining protocol
- Keywords
- Mandibular Nerve, Orthognathic Surgery, Sagittal Split Osteotomy, Sensory Retraining
- Medical subject headings
- Trigeminal Nerve Injuries, Malocclusion, Angle Class III
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sensory retraining protocolBehavioural
Also called sensory retraining
- within one month after the surgery: facial massage and physical stimulation over lower face and lip, four times (20 minutes each time) a day
- one to three months after the surgery: brush and physical stimulation over lower face and lip, four times (20 minutes each time) a day
- 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
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | No intervention will be given to this control group. Spontaneous recovery of mandibular nerve will be assessed for sensory function. |
| sensory retraining group | Experimental | Sensory retraining protocol will be applied this group. Any facilitation of sensory function in mandibular nerve will be assessed. Receives: Behavioral: sensory retraining protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
sensory function test
The sensory function evaluation include objective and subjective examinations as the followings:
- Questionnaire
- Visual analogue scale (VAS)
- Two-point discrimination (2PD)
- Pain detection threshold (PD) tests
- Touch sensory threshold
Measured: one year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionSep 2014 (estimated)
- Study completionSep 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Injury of Trigeminal NerveStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chiung Shing Huang, PhD, DDS, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01586598
- Sponsor's protocol ID
- CGMH-IRB-100-2302A3
- Status last verified
- Apr 2012
- First submitted
- 15 Feb 2012
- Last updated
- 27 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensory Retraining Exercise Facilitates Sensory Recovery After Bilateral Sagittal Split Osteotomy - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01586598
- Acronym / sponsor ID
- CGMH-IRB-100-2302A3
- Conditions
- Injury of Trigeminal Nerve, Surgery, Mandibular Prognathism
- Keywords
- Mandibular Nerve, Orthognathic Surgery, Sagittal Split Osteotomy, Sensory Retraining
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Sep 2015 (estimated)
- First posted
- 27 Apr 2012 (estimated)
- 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.
The purpose of this study is to determine whether sensory retraining exercise could improve lip numbness caused by bilateral sagittal split of mandible.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –No intervention will be given to this control group. Spontaneous recovery of mandibular nerve will be assessed for sensory function. |
| sensory retraining group | Experimental | Behavioral: sensory retraining protocolSensory retraining protocol will be applied this group. Any facilitation of sensory function in mandibular nerve will be assessed. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Taiwanese adult (18-40 y/o)
- Developmental dentofacial disharmony (Class III)
- Patients received orthognathic surgery (BSSO alone or with maxillary procedure)
Key exclusion criteria (7 listed)
- Medical condition associated with systemic neuropathy
- Unwilling to sign informed consent
- Congenital anomaly or acute trauma affecting the face
- Previous facial surgery
- Positive pain sensation at first week of post-surgery
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 |
|---|---|---|
| sensory retraining protocolAlso: sensory retraining1. 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 | Behavioural | sensory retraining group |
Primary outcome
sensory function test
Time frame: one year after surgery
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2012.
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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.
Chiung Shing Huang, PhD, DDS principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sensory retraining protocol in people with Injury of Trigeminal Nerve and Surgery, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 3 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: status not confirmed, as of the sponsor's last update on 27 Apr 2012. 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 Taiwan. 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?
Results are not available in the source record.
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?
sensory function test (time frame: one year after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Apr 2012.