Effectiveness of Vitamin B in Reducing Temporomandibular Joint Disorder Pain
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Visual Analog Scale(VAS) Pain Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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
干预措施: Neurovit Forte (Drug)
Placebo
Capsule containing 250mg corn starch
干预措施: Corn Starch (Drug)
结局指标
主要结局
Visual Analog Scale(VAS) Pain Score
时间窗: week 6
assessment of pain level with VAS score at week6
次要结局
- mouth opening measurement in millimeter (mm)(week 6)
- number of participants with treatment related adverse events as assessed by CTCAE v4.03(6 weeks)
- tablet count measurements to check complaince(6 weeks)
研究者
Dr. Winnie W.S. Choi
Clinical Assistant Professor
The University of Hong Kong