NCT02794922

Brief Summary

The purpose of this study is to determine effectiveness of vitamin B in reducing temporomandibular joint disorder (TMD) pain. Patients will be randomised to receive the study drug or placebo. The study drug we are using is a combination of vitamin B1(thiamine mononitrate)-242.5mg; vitamin B6(pyridoxineHCl)-250mg, and vitamin B12(cyanocobalamin)-1mg. We will assess patient's pain level, range of jaw movement and record any side effects from using this medication.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 30, 2016

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 9, 2016

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

May 4, 2018

Status Verified

May 1, 2018

Enrollment Period

9 months

First QC Date

May 30, 2016

Last Update Submit

May 1, 2018

Conditions

Temporomandibular Joint Disorder

Keywords

Vitamin BTemporomandibular joint disordertrpv1

Outcome Measures

Primary Outcomes (4)

  • Visual Analog Scale(VAS) Pain Score

    assessment of pain level with VAS score at baseline (week 0)

    baseline

  • Visual Analog Scale(VAS) Pain Score

    assessment of pain level with VAS score at week2

    week 2

  • Visual Analog Scale(VAS) Pain Score

    assessment of pain level with VAS score at week4

    week 4

  • Visual Analog Scale(VAS) Pain Score

    assessment of pain level with VAS score at week6

    week 6

Secondary Outcomes (6)

  • mouth opening measurement in millimeter (mm)

    baseline

  • mouth opening measurement in millimeter (mm)

    week 2

  • mouth opening measurement in millimeter (mm)

    week4

  • mouth opening measurement in millimeter (mm)

    week 6

  • number of participants with treatment related adverse events as assessed by CTCAE v4.03

    6 weeks

  • +1 more secondary outcomes

Study Arms (2)

Interventional

EXPERIMENTAL

Name: Neurovit Forte tab Dosage: Each tablet contains Vitamin B1 242.5mg, Vitamin B6 250mg, Vitamin B12 1mg Frequency: One tab, once per day Duration: 6 weeks

Drug: Neurovit Forte

Placebo

PLACEBO COMPARATOR

Capsule containing 250mg corn starch

Drug: Corn Starch

Interventions

Neurovit ForteDRUG
Also known as: Vitamin B Complex
Interventional
Corn StarchDRUG
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • minimum age of 18
  • temporomandibular joint disorder with pain
  • chronic condition- symptoms lasting more than 3 months with at least 2 episodes of pain in last 1 month
  • language competence- in Cantonese or English
  • all ethnicity

You may not qualify if:

  • ankylosis of the joint
  • limited mental capacity
  • pregnancy and lactating mothers
  • inability to take medications (NSAIDS-Ibuprofen or Vitamin B)
  • undergoing concurrent pharmacotherapy with anti inflammatory or muscle relaxant medications
  • poor general health
  • history of TMJ trauma or TMJ surgery
  • subjects taking Vitamin B for other uses

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince Philip Dental Hospital

Hong Kong, China

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

Vitamin B ComplexStarch

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

VitaminsMicronutrientsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesGlucansBiopolymersPolymersMacromolecular SubstancesDietary CarbohydratesCarbohydratesPolysaccharides

Study Officials

  • Winnie Wing Shan Choi, BDS, MDS

    Faculty of Dentistry, The University of Hong Kong

    STUDY DIRECTOR

  • Jothi R Rajaran, DDS

    Faculty of Dentistry, The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

May 30, 2016

First Posted

June 9, 2016

Study Start

September 1, 2015

Primary Completion

June 1, 2016

Study Completion

July 1, 2017

Last Updated

May 4, 2018

Record last verified: 2018-05

Locations

CN(1)