Temporomandibular Joint Disorder Clinical Trial
Official title:
Effectiveness of Vitamin B in Reducing Temporomandibular Joint Disorder Pain
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.
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.
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