Evaluation of the Efficacy of Different Drugs in the Treatment of the Pain in Patients With Temporomandibular Disorder
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Pain Evaluation
研究概览
简要总结
The most important step in the treatment of TMJ (temporomandibular joint) disease in clinical dentistry is diagnosis and planning. The clinical findings, drug requirement and biological risk of the patients determine the examination methods to be used in the Treatment of Temporomandibular Joint Disorders. In this context, it is thought that studies in the field of dentistry should be increased in order to increase the success in the treatment of TMJ Disorders. The aim of the study is to evaluate the efficacy of of different pain relievers as Dexketoprofen Trometamol + Thiocolchicoside, dexketoprofen trometamol + paracetamol and Dexketoprofen Trometamol in the treatment of pain in TMJ disorders.
详细描述
The study was carried out on 200 patients aged 18 and over, who applied to Van Yuzuncu Yıl University, Faculty of Dentistry, Department of Oral and Maxillofacial Surgery, with complaints of pain due to temporomandibular disease. When patients first applied to the clinic, their anamnesis were taken and they were directed to MR (Magnetic Resonance) imaging after clinical evaluation. Patients who meet the inclusion criteria and volunteer were included in the study. Patients were randomly divided into 4 groups. Medications were given to patients by auxiliary staff and the study was double-blind. Medicines were given as follows. Dexketoprofen Trometamol + Thiocolchicoside (25mg + 4mg, 2x1) in the 1st group, Dexketoprofen Trometamol + Paracetamol (25mg + 300mg, 2x1) in the 2nd group, only Dexketoprofen Trometamol (25mg, 2x1) in the 3rd group and paracetamol 500 mg in the 4th control group (4x1) were given. In addition, patients in each group used occlusal plate for a minimum of 8 hours per day (at night). Medicines were used regularly for 2 weeks. Paracetamol 500 mg was used only if needed for the next 2 weeks. The pain values of the patients was evaluated with the VAS scale, and the amount of mouth opening was evaluated by measuring the distance between the incisal edges of the lower and upper central teeth. Evaluations have been done at the beginning of the treatment and at the 1st week, 2nd week, 1st month and the 3rd month and the findings were recorded. After the 1st month, the patients were followed up to the 3rd month and the treatment of those who need additional treatment were continued. Obtained data will be analyzed and evaluated statistically.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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 40 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals aged 18 and over
- •Individuals without any systemic disease
- •Individuals without missing teeth
- •Individuals who have not used any medication in the last week
- •Individuals with normal TMJ MR imaging
- •Patients who applied to our clinic and had pain due to temporomandibular disease.
排除标准
- •Individuals who do not come to their check-ups regularly
- •Individuals allergic to any of the study drugs
- •Pregnant and lactating individuals
研究组 & 干预措施
Dexketoprofen Trometamol + Thiocolchicoside
(25mg + 4mg, 2x1)
干预措施: Dexketoprofen Trometamol + Thiocolchicoside (Drug)
Dexketoprofen Trometamol + Paracetamol
(25mg + 300mg, 2x1)
干预措施: Dexketoprofen Trometamol + Paracetamol (Drug)
Dexketoprofen Trometamol
(25mg, 2x1)
干预措施: Dexketoprofen Trometamol (25mg) (Drug)
Paracetamol
(500 mg, 4x1)
干预措施: Paracetamol (Drug)
结局指标
主要结局
Pain Evaluation
时间窗: 3rd month
Patients were requested to mark their pain intensity on a pain assessment form using a visual analogue scale (VAS) ranging between 0 (no pain) to 10 (most severe pain).
Trismus Evaluation
时间窗: 3rd month
Postoperative trismus will evaluated by the maximum distance between the incisive borders of the upper and lower right incisive teeth which was measured with a caliper.
Pain Evaluation (at masticatory muscles by palpation)
时间窗: 3rd month
The presence of pain in the masticatory muscles was evaluated by palpation of the muscles.
Clicking-Crepitus Evaluation
时间窗: 3rd month
Presence or absence of clicking and/or crepitus sounds detected with auscultation at temporomandibular joint.
次要结局
未报告次要终点
研究者
levent Cigerim
Head of Oral and Maxillofacial Surgery Department
Yuzuncu Yıl University
