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临床试验/NCT05830604
NCT05830604已完成不适用

Evaluation of the Effect of Muscle Activity on Subjective Tinnitus in Temporomandibular Disorders

Kutahya Health Sciences University2 个研究点 分布在 2 个国家目标入组 70 人开始时间: 2021年12月21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
70
试验地点
2
主要终点
Masseters Activity

研究概览

简要总结

Treatment of Temporomandibular Joint Disorder can help reduce subjective tinnitus levels. This treatment changes the electrical activity of the patient's chewing muscles. For this reason, the relationship between muscular change and tinnitus levels can be evaluated.

详细描述

The study will be conducted with patients who routinely apply to Kütahya Health Sciences University Faculty of Dentistry. 70 patients with temporomandibular disease accompanied by tinnitus and bruxism will be included in the study. Demographic data such as age, gender, and systemic disease, drug and trauma history data will be collected.

TMD findings of the patients will be classified according to Wilkes classification. The Wilkes classification is as follows:

  1. Stage 1 (early period): No pain or limitation of jaw movements, only reciprocal click during or after chewing. Mild anterior disc displacement in radiological evaluation.
  2. Stage 2 (early/intermediate): Mild to moderate pain with reciprocal clicking and periodic locking. Change in disc position.
  3. Stage 3 (intermediate): Joint tenderness with frequent pain. Ongoing crash. On the radiological image, changes in disc position and deformation with adhesions.
  4. Stage 4 (intermediate/late): Chronic pain that gets worse from time to time and limitation in jaw movements. Change in the shape and position of the disc and the shape of the condyle. Multiple adhesions with hard tissue changes.
  5. Stage 5 (late stage): pain that occurs from time to time with crepitation.

Bruxism data (time of onset, whether it is felt during the day/night, fatigue, difficulty in opening the mouth in the morning, stressful period) are questioned and examination findings (disc displacement, masseter hypertrophy on inspection, linea alba, attrition of teeth, fractures in restorations and teeth, muscle and joint pain) , facial asymmetry, mouth opening) will be recorded. The characteristics of tinnitus (objective/subjective, duration, in which ear, increasing and decreasing factors, type) and hearing loss, vertigo will be questioned.

Patients will be divided into two groups. Group I will consist of Wilkes Stage 1-2 patients with temporomandibular intra-articular disorder. Group II will consist of patients with both Wilkes Stage 1-2 temporomandibular intra-articular disorder and bruxism.

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

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

入选标准

  • Patients older than 18 years
  • Patients with chronic subjective tinnitus
  • Patients with Wilkes Stage 1-2

排除标准

  • Patients with Wilkes Stage 3-4-5
  • Patients with tinnitus due to audiological, neurological, metabolic or pathological reasons
  • Patients with objective tinnutus
  • Patients with normal tinnitus
  • Mentally retarded patients
  • Hearing loss, use of ototoxic drugs
  • Those with ear diseases such as acute ostitis media, perforated tympanic membrane
  • Those with Meniere's disease
  • Patients with middle ear pathology
  • Those with intracranial pathology
  • Those with traumatic cervical spine injury
  • Patients with severe depression diagnosed by a psychologist
  • Patients who have received TMB treatment in the last two months

结局指标

主要结局

Masseters Activity

时间窗: 6th months

To evaluate the symmetry and electrical activity of masseters by surface EMG

次要结局

未报告次要终点

研究者

发起方
Kutahya Health Sciences University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Berkan Altay, DDS

DDS, Assist. Prof. Department of Oral and Maxillofacial Surgery

Kutahya Health Sciences University

研究点 (2)

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