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临床试验/NCT05529290
NCT05529290已完成4 期

Evaluation of the Efficacy of Different Drugs in the Treatment of the Pain in Patients With Temporomandibular Disorder

Yuzuncu Yıl University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2019年7月16日最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

(25mg + 4mg, 2x1)

干预措施: Dexketoprofen Trometamol + Thiocolchicoside (Drug)

Dexketoprofen Trometamol + Paracetamol

Active Comparator

(25mg + 300mg, 2x1)

干预措施: Dexketoprofen Trometamol + Paracetamol (Drug)

Dexketoprofen Trometamol

Active Comparator

(25mg, 2x1)

干预措施: Dexketoprofen Trometamol (25mg) (Drug)

Paracetamol

Active Comparator

(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

发起方
Yuzuncu Yıl University
申办方类型
Other
责任方
Principal Investigator
主要研究者

levent Cigerim

Head of Oral and Maxillofacial Surgery Department

Yuzuncu Yıl University

研究点 (1)

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