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Effectiveness of Vitamin B in Reducing Temporomandibular Joint Disorder Pain

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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

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.

Condition or disease Intervention/treatment Phase
Temporomandibular Joint Disorder Drug: Neurovit Forte Drug: Corn Starch Phase 2

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 : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Vitamin B in Reducing Temporomandibular Joint Disorder Pain
Actual Study Start Date : September 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Drug: Neurovit Forte
Other Name: Vitamin B Complex

Placebo Comparator: Placebo
Capsule containing 250mg corn starch
Drug: Corn Starch



Primary Outcome Measures :
  1. Visual Analog Scale(VAS) Pain Score [ Time Frame: baseline ]
    assessment of pain level with VAS score at baseline (week 0)

  2. Visual Analog Scale(VAS) Pain Score [ Time Frame: week 2 ]
    assessment of pain level with VAS score at week2

  3. Visual Analog Scale(VAS) Pain Score [ Time Frame: week 4 ]
    assessment of pain level with VAS score at week4

  4. Visual Analog Scale(VAS) Pain Score [ Time Frame: week 6 ]
    assessment of pain level with VAS score at week6


Secondary Outcome Measures :
  1. mouth opening measurement in millimeter (mm) [ Time Frame: baseline ]
    assessment of mouth opening in millimeter (mm) at baseline (week0)

  2. mouth opening measurement in millimeter (mm) [ Time Frame: week 2 ]
    assessment of mouth opening in millimeter (mm) at week 2

  3. mouth opening measurement in millimeter (mm) [ Time Frame: week4 ]
    assessment of mouth opening in millimeter (mm) at week 4

  4. mouth opening measurement in millimeter (mm) [ Time Frame: week 6 ]
    assessment of mouth opening in millimeter (mm) at week 6

  5. 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

  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02794922


Locations
China
Prince Philip Dental Hospital
Hong Kong, China
Sponsors and Collaborators
The University of Hong Kong
Investigators
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

Responsible Party: Dr. Winnie W.S. Choi, Clinical Assistant Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT02794922     History of Changes
Other Study ID Numbers: UW 15 - 266
First Posted: June 9, 2016    Key Record Dates
Last Update Posted: May 4, 2018
Last Verified: May 2018

Keywords provided by Dr. Winnie W.S. Choi, The University of Hong Kong:
Vitamin B
Temporomandibular joint disorder
trpv1

Additional relevant MeSH terms:
Disease
Joint Diseases
Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Pathologic Processes
Musculoskeletal Diseases
Craniomandibular Disorders
Mandibular Diseases
Jaw Diseases
Muscular Diseases
Stomatognathic Diseases
Myofascial Pain Syndromes
Vitamins
Vitamin B Complex
Micronutrients
Growth Substances
Physiological Effects of Drugs