Sensory Retraining Facilitates Sensory Recovery After Mandibular Nerve Injury

NCT ID: NCT01586598

Last Updated: 2012-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2015-09-30

Brief Summary

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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

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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

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Injury of Trigeminal Nerve Surgery Mandibular Prognathism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

sensory retraining group

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

Group Type EXPERIMENTAL

sensory retraining protocol

Intervention Type BEHAVIORAL

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

Interventions

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sensory 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

Intervention Type BEHAVIORAL

Other Intervention Names

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sensory retraining

Eligibility Criteria

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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

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chiung Shing Huang, PhD, DDS

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Memorial Hospital

Locations

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Chang Gung Memorial Hospital

Taipei, Taiwan, Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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CGMH-IRB-100-2302A3

Identifier Type: -

Identifier Source: org_study_id

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