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Effectiveness of Vitamin B in Reducing Temporomandibular Joint Disorder Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02794922
Recruitment Status : Completed
First Posted : June 9, 2016
Last Update Posted : May 4, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Winnie W.S. Choi, The University of Hong Kong

Tracking Information
First Submitted Date  ICMJE May 30, 2016
First Posted Date  ICMJE June 9, 2016
Last Update Posted Date May 4, 2018
Actual Study Start Date  ICMJE September 2015
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 5, 2016)
  • Visual Analog Scale(VAS) Pain Score [ Time Frame: baseline ]
    assessment of pain level with VAS score at baseline (week 0)
  • Visual Analog Scale(VAS) Pain Score [ Time Frame: week 2 ]
    assessment of pain level with VAS score at week2
  • Visual Analog Scale(VAS) Pain Score [ Time Frame: week 4 ]
    assessment of pain level with VAS score at week4
  • Visual Analog Scale(VAS) Pain Score [ Time Frame: week 6 ]
    assessment of pain level with VAS score at week6
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 5, 2016)
  • mouth opening measurement in millimeter (mm) [ Time Frame: baseline ]
    assessment of mouth opening in millimeter (mm) at baseline (week0)
  • mouth opening measurement in millimeter (mm) [ Time Frame: week 2 ]
    assessment of mouth opening in millimeter (mm) at week 2
  • mouth opening measurement in millimeter (mm) [ Time Frame: week4 ]
    assessment of mouth opening in millimeter (mm) at week 4
  • mouth opening measurement in millimeter (mm) [ Time Frame: week 6 ]
    assessment of mouth opening in millimeter (mm) at week 6
  • number of participants with treatment related adverse events as assessed by CTCAE v4.03 [ Time Frame: 6 weeks ]
    Subjects will be assessed for any adverse events related to intervention , by using CYCAE v4.03, at week 0, week 2, week 4 and week 6
  • tablet count measurements to check complaince [ Time Frame: 6 weeks ]
    remaining tablets will be counted at end of Week 6 to check compliance rate towards treatment
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness of Vitamin B in Reducing Temporomandibular Joint Disorder Pain
Official Title  ICMJE Effectiveness of Vitamin B in Reducing Temporomandibular Joint Disorder Pain
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.
Detailed Description

Type of study : Prospective double blinded randomized control trial Sample population : patients with temporomandibular joint disorder pain who are currently undergoing treatment in Oral & Maxillofacial surgery unit, Prince Philip Dental Hospital Study Period : 2 year (1st may2015 to 1st may 2017)

Data Collection All new cases or existing TMD patients treated in oral maxillofacial surgery department, Prince Philip Dental Hospital will be acquired and screened based on inclusion and exclusion criteria. Selected patients will be categorised based on TMD axis 1 diagnosis and divided into two groups - group 1(Vitamin B) and group 2(placebo) randomly . Allocation of patients into the group will be based on computer generated by random block sequence.

Complete social demographic background of the patient will recorded according to the following format age, gender, race, education, and job.

Clinical assessment will be done to check 1. Mouth opening 2. Lateral excursion (right and left) 3. Protrusion 4. Deviation of lower jaw on opening 5. Tenderness of muscle of mastication 6. Pain - based on 10cm visual analog score.

After initial assessments, patients will be started on either vitamin B complex or placebo based on their group.

  • Both group of patients will be also prescribed with Tab Ibuprofen 400mg to be taken during acute Temporomandibular joint (TMJ) pain symptoms.
  • These patients will be reviewed on week 0,2,4 and 6.
  • All the patients will be reviewed by blinded assessor. Each patient will be given a log book to document frequency of TMJ pain attack, maximum pain score on each attack and amount of analgesics (Ibuprofen 400mg tabs) taken.
  • Log book record will be checked on their review.
  • Amount of analgesics recorded in log book and compliance of Vitamin B or placebo will be cross checked with remaining tablet count.

Data Evaluation/ Statistical Analyses The statistical analysis of this study will use the standard version of Statistical Package for the Social Sciences (SPSS) version 17.0 for windows. All the data will be gathered and entered in into this software.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Temporomandibular Joint Disorder
Intervention  ICMJE
  • Drug: Neurovit Forte
    Other Name: Vitamin B Complex
  • Drug: Corn Starch
Study Arms  ICMJE
  • Experimental: Interventional
    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
    Intervention: Drug: Neurovit Forte
  • Placebo Comparator: Placebo
    Capsule containing 250mg corn starch
    Intervention: Drug: Corn Starch
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 1, 2018)
27
Original Estimated Enrollment  ICMJE
 (submitted: June 5, 2016)
40
Actual Study Completion Date  ICMJE July 2017
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02794922
Other Study ID Numbers  ICMJE UW 15 - 266
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Winnie W.S. Choi, The University of Hong Kong
Study Sponsor  ICMJE The University of Hong Kong
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Winnie Wing Shan Choi, BDS, MDS Faculty of Dentistry, The University of Hong Kong
Principal Investigator: Jothi R Rajaran, DDS Faculty of Dentistry, The University of Hong Kong
PRS Account The University of Hong Kong
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP