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临床试验/NCT07677228
NCT07677228已完成不适用

Effectiveness of Telerehabilitation-Based Rocabado Exercises Compared With Home-Based Rocabado Exercises in Patients With Myofascial Temporomandibular Dysfunction Accompanied by Bruxism: A Randomised Controlled Trial

Mehmet Turgut1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年12月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
Pain intensity (Visual Analogue Scale)

研究概览

简要总结

This study looked at whether jaw exercises (the Rocabado exercise programme) work better when delivered through supervised online video sessions than when done at home with written instructions alone, in adults who have jaw-joint pain (temporomandibular disorder) together with teeth grinding (bruxism). Thirty adults were randomly placed into one of two groups. Both groups were taught the same exercises and asked to do them twice a day for four weeks. One group also took part in supervised video sessions three times a week, where a physiotherapist watched their exercises and gave feedback; the other group used printed exercise leaflets with weekly text-message reminders. The researchers measured jaw pain, how wide participants could open their mouth, jaw movement, stress, sleep quality and oral habits before treatment, after two weeks and after four weeks, to see which approach gave better results.

详细描述

This single-centre, parallel-group, randomised controlled trial was conducted at the Faculty of Dentistry, Nevşehir Hacı Bektaş Veli University. Participants who met the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) for myofascial temporomandibular disorder with concurrent bruxism were randomly allocated in a 1:1 ratio using a computer-generated simple randomisation sequence. Allocation was concealed using sequentially numbered, opaque, sealed envelopes that were opened only after enrolment. The outcome assessor was blinded to group allocation; participants were not blinded owing to the nature of the intervention. Both groups received identical initial face-to-face training in the Rocabado 6×6 exercise programme and were instructed to perform the exercises twice daily for four weeks. The telerehabilitation group additionally received supervised video sessions, whereas the comparator group followed the programme at home with printed materials and reminders only. Assessments were performed in person at baseline, at week 2 (mid-treatment) and at week 4 (post-treatment). The sample size was estimated using G*Power, and data were analysed with within-group and between-group statistical comparisons.

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 (Outcomes Assessor)

盲法说明

The outcome assessor was blinded to group allocation. Participants and the treating physiotherapist were not blinded owing to the nature of the intervention.

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 18-60 years
  • Diagnosis of myofascial temporomandibular disorder (TMD) with bruxism according to the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD)
  • Visual Analogue Scale (VAS) pain score ≥ 3
  • No medical treatment for TMD in the preceding 6 months
  • Access to a smartphone with internet connectivity
  • Turkish literacy and communication ability

排除标准

  • Active orthodontic or splint treatment
  • History of temporomandibular joint surgery
  • Systemic inflammatory disease
  • Pregnancy
  • Major psychiatric disorders
  • Neurological deficits in the cervical region

结局指标

主要结局

Pain intensity (Visual Analogue Scale)

时间窗: Baseline, week 2 (mid-treatment) and week 4 (post-treatment)

Pain intensity assessed using the Visual Analogue Scale (VAS), scored from 0 to 10 cm, for morning pain, pain during chewing (mastication) and night pain. Higher scores indicate greater pain.

Maximum mouth opening

时间窗: Baseline, week 2 (mid-treatment) and week 4 (post-treatment)

Maximum mouth opening measured in millimetres using a digital calliper (Mitutoyo, Japan); the mean of three consecutive measurements was recorded.

次要结局

  • Temporomandibular joint range of motion(Baseline, week 2 (mid-treatment) and week 4 (post-treatment))
  • TMD severity (Fonseca Anamnestic Index)(Baseline and week 4 (post-treatment))
  • Perceived stress (Perceived Stress Scale)(Baseline and week 4 (post-treatment))
  • Sleep quality (Jenkins Sleep Scale)(Baseline and week 4 (post-treatment))
  • Oral parafunctional habits (Oral Behaviours Checklist)(Baseline and week 4 (post-treatment))

研究者

发起方
Mehmet Turgut
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Mehmet Turgut

Prof. Dr. Mehmet Turgut

Nevsehir Haci Bektas Veli University

研究点 (1)

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