跳至主要内容
临床试验/NCT03891121
NCT03891121已完成不适用

Which One is Effective in Treatment of Bruxism? Occlusal Splints or Botulinum Toxin

Ankara University1 个研究点 分布在 1 个国家目标入组 73 人开始时间: 2018年4月5日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
73
试验地点
1
主要终点
VAS

研究概览

简要总结

73 patients with myofascial pain due to bruxism were included in this study. The patient were allocated into three groups. Group A was treated with occlusal splint, Group B was treated with botulinum toxin injection, Group C was treated with occlusal splint and botulinum toxin injection together. Temporomandibular Disorder Pain Screener (TMD-PS), Graded Chronic Pain Scale (GCPS), Oral Behavior Checklist (OBC), Jaw Function Limitation Scale (JFLS), Visual Analog Scale (VAS) by palpation of the chewing muscles were administered to all patients before treatment and at 6 months after treatment.

详细描述

A number of 173 patients were examined for myofascial pain due to TMD in the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Ankara University between April-August 2018. An informed consent was taken from all the patients after obtaining Institutional Ethical Committee approval. The study was performed in accordance with the Helsinki Declaration and all participants signed an informed consent agreement. Patients were included in this randomized, blinded, prospective study accordance with the Consolidated Standards of Reporting Trials (CONSORT) statement and the study was performed by blinded three examiners.

Patients older than 18 years with chronic myofascial pain, more than 6 months with myofascial pain, diagnosis of myofascial pain according to the Research Diagnostic Criteria (RDC) of TMD were included to the study. Patients having intracapsular TMD (disc displacement with or without reduction), a history of any treatment for bruxism, patients taking aminoglycosides, penicillamine, quinine and calcium blockers, pregnant or lactating mothers, having neuromuscular disorder (e.g. Orofacial tardive dyskinesia, Lambert-Eaton Syndrome, Myasthenia gravis), having rheumatoid arthritis, having temporomandibular joint osteoarthrosis with radiographic signs, history of previous joint surgery, patients who had undergone botulinum toxin (BTX) treatment before or an allergy to BTX-A were excluded from the study.

The patients who have myofascial pain were diagnosed and examined with using RDC/TMD diagnostic categories I in the RDC/ TMD by first examiner (M.E.Y) and 102 patients fulfilled inclusion criteria. 8 patients did not agree to participate. 94 patients were allocated to 3 groups according to a computer-generated randomization code. Block randomization was done. Patient groups were as follows:

Group A was treated with occlusal splint Group B was treated with botulinum toxin injection, Group C was treated with occlusal splint and botulinum toxin injection together Visual Analog Scale (VAS), TMD Pain Screener(TMD-PS), Graded Chronic Pain Scale (GCPS), Oral Behavior Checklist (OBC), Jaw Function Limitation Scale (JFLS) were administered to all patients before treatment and at 6th months after treatment by third examiner (K.T.S). Patients' pain was examined by palpation of the chewing muscles and the pain was marked from 0 to 10 on the VAS before and after the treatment.

Questionnaires TMD Pain Screener is a self-report, simple, reliable questionnaire used to assess for the presence of any pain-related TMD. Full version with 6 questions were applied. The total score is between 0 and 7. If the total score is between 0 and 3 points, there is no TMD. If the total score is between 4 and 7, there is TMD.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

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

  • Patients older than 18 years with chronic myofascial pain
  • More than 6 months with myofascial pain
  • Diagnosis of myofascial pain according to the RDC/TMD

排除标准

  • Patients having intracapsular TMD (disc displacement with or without reduction)
  • A history of any treatment for bruxism, patients taking aminoglycosides
  • Penicillamine
  • Quinine and calcium blockers
  • Pregnant or lactating mothers
  • Having neuromuscular disorder (e.g. Orofacial tardive dyskinesia, Lambert-Eaton Syndrome, Myasthenia gravis)
  • Having rheumatoid arthritis
  • Having temporomandibular joint osteoarthrosis with radiographic signs
  • History of previous joint surgery
  • Patients who had undergone BTX treatment before or an allergy to BTX-A

研究组 & 干预措施

Botulinum toxin

Experimental

Patients were treated with botulinum toxin injection.

干预措施: Botulinum toxin type A (Drug)

Occlusal splint

Experimental

Patients were treated with occlusal splint.

干预措施: Occlusal Splint (Device)

Both

Experimental

Patients were treated with occlusal splint and botulinum toxin injection together.

干预措施: Occlusal Splint (Device)

Both

Experimental

Patients were treated with occlusal splint and botulinum toxin injection together.

干预措施: Botulinum toxin type A (Drug)

结局指标

主要结局

VAS

时间窗: 1 minute

Visual Analog Scale:Patients' pain was examined by palpation of the chewing muscles and the pain was marked from 0 to 10 on the VAS before and after the treatment. Higher values represent a worse outcome.

TMD-PS

时间窗: 2 minutes

TMD Pain Screener is a self-report, simple, reliable questionnaire used to assess for the presence of any pain-related TMD. Full version with 6 questions were applied. The total score is between 0 and 7. If the total score is between 0 and 3 points, there is no TMD. If the total score is between 4 and 7, there is TMD. Higher values represent a worse outcome.

JFLS

时间窗: 3 minutes

Jaw Function Limitation Scale evaluates the universal limitations on chewing, jaw mobility, verbal and emotional expression. The patient indicates the level of limitation the mentioned activities from 0 to 10.Higher values represent a worse outcome.

OBC

时间窗: 5 minutes

Oral Behaviors Checklist evaluates the effects of oral parafunctional habits on the masticatory system and the frequency of these habits. Scoring can be computed as the sum of the number of 21 items and the total score is between 21 and 105. Higher values represent a worse outcome.

GCPS

时间窗: 2 minutes

Graded Chronic Pain Scale is a reliable, short and valid tool that evaluates pain intensity and pain related disability with 7 questions. After the scoring, it is classified to 5 grades. Grade 0 with no intensity and disability, Grade 1 with low intensity and low disability, Grade 2 high intensity and low disability, Grade 3 with high disability and moderately limiting, Grade 4 with high disability and severely limiting. Higher values represent a worse outcome.

次要结局

未报告次要终点

研究者

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

Mehmet Emre Yurttutan

DDS, PhD, Oral and Maxillofacial Surgery Specialist

Ankara University

研究点 (1)

Loading locations...

相似试验