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临床试验/NCT07827495
NCT07827495已完成不适用

Synchronous vs Asynchronous Telerehabilitation for Bruxism: A Randomized Controlled Trial

Gazi University1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2025年8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
34
试验地点
1
主要终点
Change in Pain Intensity

研究概览

简要总结

The goal of this clinical trial was to learn if online exercise and self-massage programs could lower pain and improve jaw movement in adults with bruxism (teeth grinding or clenching). The main questions it aimed to answer were:

Did live video exercise guided by a physical therapist lower jaw pain more than an independent video exercise program? Did live video exercise guided by a physical therapist improve mouth opening more than an independent video exercise program? Researchers compared live video sessions to independent video exercises to see which approach worked better for improving jaw function, sleep quality, and daily life.

Participants:

Completed an 8-session exercise and self-massage program over 4 weeks (2 times each week).

Either practiced live with a physical therapist over video calls or followed recorded video exercises on their own at home.

Answered surveys about pain, sleep quality, and oral health before and after the 4-week program.

Had their mouth opening, jaw muscle sensitivity, and muscle activity tested before and after the program.

详细描述

Bruxism is characterized by repetitive masticatory muscle activity leading to masticatory muscle pain, restricted mandibular range of motion, and impaired oral health-related quality of life. Telerehabilitation represents a promising alternative to conventional face-to-face physiotherapy to overcome accessibility barriers.

In this prospective, randomized, two-arm parallel-group controlled trial, individuals diagnosed with clinically-based bruxism were randomly assigned to either the Synchronous Telerehabilitation Group (S-TRG) or the Asynchronous Telerehabilitation Group (A-TRG).

Both groups completed an 8-session intervention protocol over 4 weeks (2 sessions per week). The intervention protocol comprised:

Breathing training protocol (deep diaphragmatic breathing), Cervical region stretching and chin-tuck exercises, Temporomandibular joint range of motion and stretching exercises, Bilateral self-massage techniques (sliding, kneading, friction, and ischemic compression to masseter and temporalis muscles), Scapular stabilization exercises (W, T, and Y exercises).

In the S-TRG, sessions were conducted in real time under the direct supervision of a physiotherapist via live video calls. In the A-TRG, participants were taught the exercises in an initial recorded live video session and subsequently performed the protocol independently using their personalized instructional video recordings, with weekly phone/text check-ins to monitor adherence and screen for adverse events. Additionally, all participants received a standardized patient education brochure on TMJ care and behavioral modifications.

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
None

入排标准

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

入选标准

  • Diagnosed with clinically-based bruxism
  • Aged 18 years or older
  • Voluntarily agreed to participate and provided written informed consent

排除标准

  • Prior or concurrent neurological, psychiatric, or systemic diseases
  • Ongoing dental treatment
  • Currently receiving physical therapy
  • Regular use of medications such as analgesics or muscle relaxants
  • History of surgery or trauma involving the temporomandibular joint (TMJ) or neck region
  • Pregnancy
  • Active cancer
  • Planned surgical procedures
  • Visual, auditory, or cognitive impairments that could potentially confound the study outcomes
  • History of receiving treatment for the TMJ within the preceding 3 months

研究组 & 干预措施

Synchronous Telerehabilitation Group (S-TRG)

Experimental

Participants completed an 8-session therapeutic exercise and self-massage program over 4 weeks (2 sessions per week) via real-time live video calls under the direct supervision of a physiotherapist. They also received TMJ patient education and behavioral modification brochures.

干预措施: Synchronous Telerehabilitation Protocol (Behavioral)

Asynchronous Telerehabilitation Group (A-TRG)

Active Comparator

Participants were taught the same 8-session exercise and self-massage protocol in an initial live recorded video session and subsequently performed the exercises independently at home for 4 weeks using personalized video recordings, supported by weekly check-ins. They also received TMJ patient education and behavioral modification brochures.

干预措施: Asynchronous Telerehabilitation Protocol (Behavioral)

结局指标

主要结局

Change in Pain Intensity

时间窗: Baseline and post-intervention (Week 4)

Assessed using the Numeric Rating Scale (NRS), an 11-point scale ranging from 0 (no pain) to 10 (worst possible pain). Pain intensity is evaluated at rest, during the night, in the morning upon waking, and during jaw activity/function.

次要结局

  • Change in Maximum Mouth Opening (MMO)(Baseline and post-intervention (Week 4))
  • Change in Pressure Pain Threshold (PPT)(Baseline and post-intervention (Week 4))
  • Change in Pressure Pain Tolerance (PPTol)(Baseline and post-intervention (Week 4))
  • Change in Masticatory Muscle Activity (sEMG)(Baseline and post-intervention (Week 4))
  • Change in Oral Health-Related Quality of Life (OHIP-14)(Baseline and post-intervention (Week 4))
  • Change in Subjective Sleep Quality (PSQI)(Baseline and post-intervention (Week 4))

研究者

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

Gamze COBANOGLU

Assistant Professor

Gazi University

研究点 (1)

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