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临床试验/NCT02380105
NCT02380105已完成不适用

Effectiveness of a Counseling Program for TMD Treatment

Universidade Federal do Rio Grande do Norte0 个研究点目标入组 50 人开始时间: 2012年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
50
主要终点
Pain as measured by Visual Analogue Scale (VAS)

研究概览

简要总结

This study aims to evaluate the effectiveness of counseling on pain, function and well-fare outcomes for the management of patients with temporomandibular disorder (TMD).

详细描述

In this study, 51 patients were allocated to one of the research groups. In Group I, it was instituted counseling therapy. For Group II was conducted treatment as usual with occlusal splint. Patients were followed for returns at 7, 15, 30 and 60 days after baseline. At baseline, all patients were examined and assessed Research Diagnostic Criteria/Temporomandibular Disorder (RDC/TMD form). In addition, the patients were referred for specific treatment according to the group to which belonged. In each session, patients were also surveyed about pain intensity using a Numeric Scale. To analyze the impact of pain on quality of life, Oral Health Impact Profile (OHIP-14) questionnaire was used.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

性别
Female
接受健康志愿者
否

入选标准

  • •Female individuals
  • •Positive diagnosis of TMD according to RDC/TMD
  • •Presence of pain in the orofacial region persisting for at least a week of at least moderate intensity, according to the Numeric Scale of pain

排除标准

  • •TMD treatment for ongoing pain
  • •Presence of pulpal or periodontal disease
  • •Orthodontic treatment in progress
  • •Daily use of analgesics, antidepressants or muscle relaxants
  • •History of radiotherapy to the head and neck, or any adverse systemic condition that may favor presentation of symptoms involved

研究组 & 干预措施

Counseling Group

Experimental

Patients allocated to the counseling group (Group I) were informed about possible etiological factors and educated to not overload the temporomandibular joint and masticatory muscles. Techniques to relieve pain and tension were taught to correct postural habits, food and sleep irregularities. The patients received written instructions, as a way of reinforcing the information provided during the initial consultation. In subsequent returns at 7, 15, 30 and 60 days of follow-up, the instructions were given again and patients were asked whether they had detected any habits related to the initiation and maintenance of painful symptoms of TMD, as a way to further highlight the association between the presence of these harmful behaviors and the worsening signs and symptoms of TMD.

干预措施: Counseling (Behavioral)

Splint Group

Active Comparator

Patients allocated to the splint group (Group II) were treated using interocclusal appliances, according to the following protocol: At baseline, an anterior bite plate (front-plateau) was made from acrylic resin that was placed in the maxillary arch to include the the canine to canine region and promote the disocclusion of the posterior teeth. Patients were instructed to use the device for 24 hours, interspersed with rests of equal length during the first week. After 7 days, the device was removed. A hard splint was then made. At 30 days of follow-up, the splint was fitted and the patients were also asked to use it when they were sleeping.

干预措施: Interocclusal Appliances (Device)

结局指标

主要结局

Pain as measured by Visual Analogue Scale (VAS)

时间窗: Baseline, 7, 15, 30, 60 days

Visual Analogue Scale

次要结局

  • Quality of life measured by Oral Health Impact Profile (OHIP)(Baseline, 7, 15, 30, 60 days)
  • Functional Evaluation measured by TemporoMandibular Index (TMI)(Baseline, 7, 15, 30, 60 days)

研究者

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

Rodrigo Falcão Carvalho Porto de Freitas

de Freitas

Universidade Federal do Rio Grande do Norte

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