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
|Condition or disease||Intervention/treatment||Phase|
|Temporomandibular Joint Disorder||Drug: Neurovit Forte Drug: Corn Starch||Phase 2|
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|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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
- 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
- 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
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
|Prince Philip Dental Hospital|
|Hong Kong, China|
|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|