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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.
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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional | Experimental | 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 |
|
| Placebo | Placebo Comparator | Capsule containing 250mg corn starch |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neurovit Forte | Drug |
|
| |
| Corn Starch |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Winnie Wing Shan Choi, BDS, MDS | Faculty of Dentistry, The University of Hong Kong | Study Director |
| Jothi R Rajaran, DDS | Faculty of Dentistry, The University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prince Philip Dental Hospital | Hong Kong | China |
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| ID | Term |
|---|---|
| D013705 | Temporomandibular Joint Disorders |
| ID | Term |
|---|---|
| D017271 | Craniomandibular Disorders |
| D008336 | Mandibular Diseases |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D014803 | Vitamin B Complex |
| D013213 | Starch |
| ID | Term |
|---|---|
| D014815 | Vitamins |
| D018977 | Micronutrients |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
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| Drug |
|
| 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 |
| D007592 |
| Joint Diseases |
| D009135 | Muscular Diseases |
| D009057 | Stomatognathic Diseases |
| D020164 |
| Chemical Actions and Uses |
| D005936 | Glucans |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D011134 | Polysaccharides |