COMPARISON OF THE EFFECTS OF OROFACIAL AND TONGUE EXERCISES APPLIED AS AN ADDITION TO MYOFUNCTIONAL TREATMENT IN TEMPOROMANDIBULAR JOINT DISORDERS ON PAIN, JOINT AND TONGUE FUNCTIONS: A RANDOMIZED CONTROLLED TRIAL
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- orofacial myofunctional evaluation with scores
研究概览
简要总结
The goal of this clinical trial is to learn if orofacial exercises works to treat temporomandibular disorders in adults. It will also learn about the safety of orofacial exercises on temporomandibular disorders. The main questions it aims to answer are:
Does orofacial exercises improve function of temporomandibular disorders ? Does orofacial exercises decrease pain in temporomandibular disorders?
Researchers will compare orofacial exercises and manual therapy to manual therapy.
Participants will:
Take manual therapy and orofacial exercises or manual therapy two days in every week for 6 weeks Assessment once every 2 weeks for tests
详细描述
The study will be conducted with two groups. While the control group will receive myofunctional therapy, the intervention group will receive orofacial and tongue exercises in addition to myofunctional therapy. The inclusion of orofacial and tongue exercises in the intervention group constitutes the main hypothesis of the study. The myofunctional therapy consists of home exercises, normal cervical joint movements, and massage techniques targeting the masticatory muscles.
At baseline, participants' eligibility for inclusion will be assessed. Individuals who meet the inclusion criteria will be randomly assigned to one of the two groups using a sealed envelope randomization method. Evaluation of participants will begin with the collection of demographic data. After recording the demographic information, further assessments will be conducted through questionnaires and instrumental measurements.
The first assessment will focus on pain evaluation, using three different methods.
- Numerical Pain Scale (NPS): This scale assesses pain intensity in three different conditions - during chewing, at rest, and during sleep. Participants will rate their pain on a scale from "0" (no pain) to "10" (worst imaginable pain).
- Pain Catastrophizing Scale (PCS): This self-administered questionnaire evaluates the participant's thoughts and emotional responses related to pain.
- Algometry: The pain thresholds of the superficial masticatory muscles (masseter and temporalis) will be determined. Three measurements will be taken from the most prominent point of each muscle with the algometer applied perpendicularly to the skin. The highest value among the three will be recorded as the pain threshold for that muscle.
Jaw function will be another measured parameter, assessed using two different methods-one questionnaire and one physical evaluation.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 - 65 aged people
- •Not having received physical therapy for the neck or jaw within the past three months.
- •No history of surgical or oncological treatment related to the neck or jaw.
- •Having a diagnosis of temporomandibular disorder according to the RDC/TMD criteria, specifically Group Ia, Group Ib, or Group IIa under Axis I.
排除标准
- •Individuals who are pregnant or suspected to be pregnant.
- •Individuals with rheumatologic diseases affecting the temporomandibular joint.
- •Individuals with a diagnosed psychiatric disorder.
结局指标
主要结局
orofacial myofunctional evaluation with scores
时间窗: From enrolment to the end of treatment at 6 weeks, in every two weeks
The Orofacial Myofunctional Evaluation with Scores (OMES) protocol is designed to assess oral dysfunctions through multiple subdomains. These subdomains include appearance and posture, mobility, function, swallowing, mastication, functional occlusion, and mandibular movement. Higher scores indicate better functional status. The protocol has not yet been validated in Turkish. It was first used in a pediatric population and has also demonstrated validity in individuals with temporomandibular disorders.
次要结局
- Pain threshold level of temporomandibular joint and temporal regions(From enrollment to the end of treatment at 6 weeks, once every two weeks.)
- Pain Level of Numerical Pain Scale(From enrollment to the end of treatment at 6 weeks, once in every two weeks)
研究者
Tayfun ISIK
Master of Science, Lecturer
Ankara Medipol University