Comparative Evaluation of Topical Magnesium Sulphate Gel With and Without Iontophoresis in Management of Masseter Myalgia in Temporomandibular Joint Disorders A Randomized Controlled Study
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 62
- 试验地点
- 1
研究概览
简要总结
62 Clinically proven cases of temporomandibular joint disorder cases reporting to department of Oral Medicine and Radiology with Baseline assessment of clinical parameters VAS score, maximum mouth opening MMO and quality of life randomised allocation of 62 participants of GROUP I 31 participants Topical magnesium sulphate gel iontophoresis done twice weekly for 4 weeks and GROUP II 31 participants Topical magnesium sulphate gel application done twice weekly for 4 weeks. For both the groups assessment of the outcome measuments VAS score, maximum mouth opening MMO and quality of life Will be done before treatment immediately after first session and finally after treatment. Data collected will be compiled onto an MS Office 365 Excel worksheet and will be subjected to statistical analysis using SPSS 26.0 software. drop-outs ,if there is 5% loss of subjects during the follow up, ethical clearance obtained from the Institutional Ethical Committee and review board of Government Dental College and Research Institute, Bengaluru.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants with TMDs having unilateral or bilateral masseter myalgia based on DC/TMD criteria.1( Annexure III)
- •Participants 18 to 60 years of age of either gender .
排除标准
- •EXCLUSION CRITERIA:
- •The presence of congenital abnormalities affecting TMJ and associated structures.
- •The presence of systemic diseases like cervicalgia or rheumatological diseases like rheumatoid arthritis, ankylosing spondylitis, lupus erythematosus, viral myalgia etc.
- •Any history of trauma ,cervical spine or TMJ surgery
- •Patients who are undergoing orthodontic treatment or recent extractions .
- •Patients currently under treatment for temporomandibular disorders.
- •Patients with history of radiation treatment to head and neck region.
- •Individuals with pacemakers and metal implants.
- •Pregnant and lactating women.
- •Patients who have limited mouth opening due to non-TMD causes such as odontogenic infections,OSMF,fractures etc.
- •Patients under medications which can affect muscle activity like muscle relaxants, antidepressants, etc
- •Patients with history of skin allergy/allergic to medications used in present treatment .
- •Patients who had any infection, lesion or trauma in the region of electrode placement.
研究者
Dr Swathy M S
Government dental college and research institute bangalore