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临床试验/NCT03096301
NCT03096301Unknown不适用

Photomodulation in the Treatment of Pain in Patients With Tmd: Analysis of Cost-effectiveness.

University of Nove de Julho2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2017年10月10日最近更新:
适应症

试验速览

阶段
不适用
入组人数
45
试验地点
2
主要终点
Pain

研究概览

简要总结

The general purpose of this project is to evaluate the cost-effectiveness of LIL treatment and occlusal plates in the treatment of pain in patients between 15 and 25 years of age with TMD.

详细描述

Temporomandibular disorder (TMD) affects a significant portion of the population. Epidemiological data show that the signs and symptoms of TMD start to become apparent from six years of age, and in adolescence these signs and symptoms are similar to those of adults. The painful conditions of TMD can affect the quality of life of young patients, compromising the daily activities of these individuals. The present project aims (1) to estimate the direct costs of treatment of muscle pain in patients with TMD with low-intensity laser and with occlusal plate and a placebo group; (2) to evaluate the effectiveness of the treatments with low-intensity laser and occlusal plate for muscle pain in patients with TMD; (3) to analyze the cost-effectiveness of the two proposed treatments for pain; and (4) to describe and compare the results of analyses of treatments for pain in patients with TMD. The study will be conducted at the Odontological Clinic of Universidade Nove de Julho. It is a prospective trial of clinical and economic analysis. It will include 30 patients aged between 15 and 25 years with TMD, randomly assigned to a treatment group: G1 (low-power laser), G2 (occlusal plate) and G3 (placebo). The analysis will be based on the direct costs of each treatment during the 12-month period, estimating the cost of each treatment. The outcome for the analysis of the effectiveness will be the pain, measured periodically by means of the clinical examination of the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD). The cost-effectiveness ratio will be calculated using, as endpoints, pain and the calculation of the ratio between the difference in costs between the groups studied. The evaluation of the impact of the treatment on quality of life will be determined by applying the adapted EuroQol-5D.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
15 Years 至 25 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • people between 15 and 25 years
  • diagnosis of TMD in group I

排除标准

  • Individuals with dental-facial anomalies
  • orthodontic or orthopedic treatment
  • Individuals who were taking muscle relaxants or anti-inflammatory medications

结局指标

主要结局

Pain

时间窗: 12 months after treatment

Muscle pain will be analyzed by clinical criteria of the Research Diagnostic Criteria for Temporomandibular Disorders

次要结局

  • Cost-effectviness(12 months after treatment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lara Jansiski Motta

Professor

University of Nove de Julho

研究点 (2)

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