Effectiveness of Vitamin B in Reducing Temporomandibular Joint Disorder Pain

May 1, 2018 updated by: Dr. Winnie W.S. Choi, The University of Hong Kong
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.

Study Overview

Status

Completed

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

Enrollment (Actual)

27

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Hong Kong, China
        • Prince Philip Dental Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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
Other Names:
  • Vitamin B Complex
Placebo Comparator: Placebo
Capsule containing 250mg corn starch

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale(VAS) Pain Score
Time Frame: baseline
assessment of pain level with VAS score at baseline (week 0)
baseline
Visual Analog Scale(VAS) Pain Score
Time Frame: week 2
assessment of pain level with VAS score at week2
week 2
Visual Analog Scale(VAS) Pain Score
Time Frame: week 4
assessment of pain level with VAS score at week4
week 4
Visual Analog Scale(VAS) Pain Score
Time Frame: week 6
assessment of pain level with VAS score at week6
week 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mouth opening measurement in millimeter (mm)
Time Frame: baseline
assessment of mouth opening in millimeter (mm) at baseline (week0)
baseline
mouth opening measurement in millimeter (mm)
Time Frame: week 2
assessment of mouth opening in millimeter (mm) at week 2
week 2
mouth opening measurement in millimeter (mm)
Time Frame: week4
assessment of mouth opening in millimeter (mm) at week 4
week4
mouth opening measurement in millimeter (mm)
Time Frame: week 6
assessment of mouth opening in millimeter (mm) at week 6
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
6 weeks
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
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2015

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

July 1, 2017

Study Registration Dates

First Submitted

May 30, 2016

First Submitted That Met QC Criteria

June 5, 2016

First Posted (Estimate)

June 9, 2016

Study Record Updates

Last Update Posted (Actual)

May 4, 2018

Last Update Submitted That Met QC Criteria

May 1, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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