Effectiveness of Vitamin B in Reducing Temporomandibular Joint Disorder Pain

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effectiveness of Vitamin B in Reducing Temporomandibular Joint Disorder Pain

Conditions
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Temporomandibular Joint Disorder

Intervention / Treatment
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* Drug: Neurovit Forte
* Drug: Corn Starch


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventional<br>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<br> <br> * Other names: Vitamin B Complex;|
| Placebo Comparator: Placebo<br>Capsule containing 250mg corn starch | Drug: Corn Starch<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mouth opening measurement in millimeter (mm) | assessment of mouth opening in millimeter (mm) at baseline (week0) | baseline | 
| mouth opening measurement in millimeter (mm) | assessment of mouth opening in millimeter (mm) at week 2 | week 2 | 
| mouth opening measurement in millimeter (mm) | assessment of mouth opening in millimeter (mm) at week 4 | week4 | 
| mouth opening measurement in millimeter (mm) | 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 | 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 | remaining tablets will be counted at end of Week 6 to check compliance rate towards treatment | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitamin B, Temporomandibular joint disorder, trpv1