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临床试验/NCT02908568
NCT02908568Unknown2 期

Effect of Stimulation of the Proprioceptive Trigeminocardiac Reflex Through Medical Device for the Pain of Patients With Temporomandibular Disorders

Azienda USL 12 Versilia0 个研究点目标入组 36 人开始时间: 2016年9月1日最近更新:
适应症
干预措施

试验速览

阶段
2 期
发起方
入组人数
36
主要终点
Mandibular stretching influences the temporomandibular disorders

研究概览

简要总结

Study over muscular stretching to reduce pain the oral cavity.

详细描述

It is a current opinion that muscular stretching is able to reduce pain and to allow increase of the opening excursion at the joints. To investigate this possibility in the face, the investigators developed a method of stretching associated with large dynamic jaws during chewing using a special device (Spring Device ®) for ten minutes, allowing the muscles of the oral cavity to relax. The height of the bite was set as two-thirds of the maximum opening (max. 2 cm.) of the mouth at rest (without forcing) thus avoiding maintaining the head of the condyle at maximum aperture for a long time. The subjects were then analyzed by means of kinesiography to determine the changes in the vertical dimension. Increasing stretching produces neuromuscular relaxation and a reduction of pain. This study showed that this therapy induces oral and extraoral pain reduction and increases neck mobility and mouth opening. The stimulation of trigeminal receptors is an important drive for therapy in the trigeminocardiac reflex (TCR).

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 (Investigator)

入排标准

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

入选标准

  • •All the subjets up to seventy years

排除标准

  • •Subjects under eight years

研究组 & 干预措施

Spring device

Experimental

Brisk dilatation of fhe mouth.

干预措施: Spring device (Device)

Mandible stimulator

Sham Comparator

Stimulation of fhe mouth.

干预措施: Mandible stimulator (Device)

结局指标

主要结局

Mandibular stretching influences the temporomandibular disorders

时间窗: up to 24 weeks

It is a current opinion that muscular stretching is able to reduce pain and to allow increase of the opening excursion at the joints. To investigate this possibility in the face, the investigators developed a method of stretching associated with large dynamic jaws during chewing using a special device (Spring Device ®) for ten minutes, allowing the muscles of the oral cavity to relax.

次要结局

  • mandibular stretching induces a reduction of facial contraction and decrease of heart rate(up to 24 weeks)

研究者

发起方
Azienda USL 12 Versilia
申办方类型
Other
责任方
Principal Investigator
主要研究者

PROF. UGO COVANI

Azienda USL 12 Versilia

Azienda USL 12 Versilia

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