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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

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

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20181030001
Enrollment
90
Registered
2018-10-30
Start date
2018-10-29
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

recovery of neurosensory disturbance after Bilateral Sagittal Split Ramus Osteotomy. vitamin B orthognathic surgery nerve injury neurosensory disturbance

Interventions

Each patient will be prescribed vitamin B1&#45
12 (SAMBEE® tablet) as 1 tab tid pc after BSSRO for 6 months. ,Each patient will be prescribed vitamin B 12 (Methylcobal® 500 mg tablet) as 1 tab tid pc after BSSRO for 6 months. ,Each patient will
Active Comparator Dietary Supplement,Active Comparator Dietary Supplement,No Intervention Dietary Supplement
vitamin B1&#45
12 ,vitamin B12,Control

Sponsors

Chulalongkorn University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 50 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Quality of life of patients immediately, 1 week, 1 months, 3 months and 6 months after BSSRO Questionaire

Countries

Thailand

Contacts

Public ContactPaksinee Kamolratanakul

Department of Oral and Maxillofacial Surgery

Orepaksinee@yahoo.com+668158441

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026