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Vitamin B1-6-12 and vitamin B12 to improve the reduced sensation from Bilateral Sagittal Split Ramus Osteotomy: a prospective randomised double blind controlled clinical trial

Phase 4
Recruiting
Conditions
nerve injury
recovery of neurosensory disturbance after Bilateral Sagittal Split Ramus Osteotomy.
vitamin B
orthognathic surgery
neurosensory disturbance
Registration Number
TCTR20181030001
Lead Sponsor
Chulalongkorn University
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
90
Inclusion Criteria

1.BSSRO procedure with or without maxillary procedure (without genioplasty) and have reduced sensation after surgery (GSS≤12)
2.Aged between 20-50 years
3.Healthy patient, no medical problems
4.No numbness or unusual feeling on the face before surgery
5.No psychological problems
6.No infection problems
7.No sensitivity to vitamin B

Exclusion Criteria

1.Perioperative complications such as bone exposed, partial or complete nerve dissection, excessive bleeding or unfavorable bone fracture
2.Postoperative complications such as postoperative infection, the operation that need second operation (for example: broken bur)
3.Patient with postoperative dysesthesia that need microneurosurgery
4.Patient who receive other medication that influence nerve healing
5.Patient lost follow-up in 6 months after surgery
6.Non co-operative patients

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The recovery of neurosensory disturbance immediately, 1 week, 1 month, 3 months and 6 months after BSSRO Clinical Neurosensory Test with static and moving 2 point discrimination, light touch and pinprick
Secondary Outcome Measures
NameTimeMethod
Quality of life of patients immediately, 1 week, 1 months, 3 months and 6 months after BSSRO Questionaire
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