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临床试验/NCT03000790
NCT03000790Unknown不适用

Clinical Evaluation of Lingual Ring Splint For Management Anterior Disc Displacement With Reduction (Pilot Study Clinical Trial)

Cairo University0 个研究点目标入组 10 人开始时间: 2016年12月最近更新:
适应症

试验速览

阶段
不适用
入组人数
10
主要终点
Patients' subjective pain experience.

研究概览

简要总结

To evaluate the effectiveness of Lingual Ring Splint For Management of Anterior Disc Displacement With Reduction

详细描述

To evaluate the effectiveness of Lingual Ring Splint For Management of Anterior Disc Displacement With Reduction.

PICO P- Patient with symptomatic anterior disc displacement with reduction . I- use of Michigan splint C- use of anterior repositioning splint (ARS) . O- Clinical outcome. Pain relief and improvement of mouth opening , lateral excursion and protrusion

Outcome:

  • 1ry outcome: Patients' subjective pain experience. Each patient will be asked to rate his or her current and worst pain intensity on numerical rating scale (NRS) of 0-10 with zero being no pain and ten corresponds to the worst pain that the patient ever had.
  • 2ry outcome:
  1. Maximum mouth opening (MMO). Assessment of MMO will be performed by measuring the distance in mm between the incisal edges of the upper and lower central incisors using a ruler.
  2. lateral excursion . Assessment of lateral excursion will be performed by measuring the distance in mm between midline of upper and lower jaws
  3. protrusion. The distance in mm from the incisal edge of the maxillary central incisor to the incisor edge of the mandibular incisor will measured in the maximum protruded position.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Adult patient from 15 to 50 years old.
  • Report of pain in preauricular region, in the last 30 days, worsened by functional activities, such as chewing and talking.
  • Presence of disc displacement with reduction, arthralgia and joint clicking that occurred at both middle to late opening and late closing (near maximum cuspation) and pain in the TMJ area aggravated by jaw movement and function.
  • positive diagnosis of unilateral or bilateral anterior disc displacement with reduction by means of magnetic resonance imaging (MRI).

排除标准

  • Individuals with a recent history of trauma in the face and/or neck area.
  • Individuals with systemic diseases that can affect TMJ.
  • History of TMJ surgery.
  • Individuals with dental pain.
  • Individuals with myofascial pain, disc displacement with reduction or osteoarthritis.
  • Individuals under dental or TMD management.
  • Individuals wearing full or partial dentures.
  • Individuals with major psychological disorders.
  • Nonreducing dislocations of the articular disk in the acute form of TMD
  • Consequences of condoyle fractures and/or fracture of another maxillofacial zone.
  • In therapy for the same pathologies.
  • Articular pathologies of systemic nature (e.g., rheumatoid arthritis, arthrosis, psoriasis arthritis).
  • Well-known pathologies of neurologic and/or psychic nature and other forms of migraine.

结局指标

主要结局

Patients' subjective pain experience.

时间窗: 3 months

Each patient will be asked to rate his or her current and worst pain intensity on numerical rating scale (NRS) of 0-10 with zero being no pain and ten corresponds to the worst pain that the patient ever had.

次要结局

  • Protrusion.(3 months)
  • Lateral excursion.(3 months)
  • Maximum mouth opening.(3 months)

研究者

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

Ahmed Gamal Nassar

Dentist at ministry of health

Cairo University

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