A multicenter, randomized, double-blind, sham-controlled, Superiority, confirmatory clinical trial to evaluate the safety and effectiveness of a Clickless DTx digital therapy device for patients diagnosed with temporomandibular disorders (TMD)

Beyondmedicine0 个研究点目标入组 102 人开始时间: 待定最近更新: 2024年6月24日

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•1) Adults aged 19 to 65 years old.
•2) Patients diagnosed with temporomandibular joint disorders.
•3) Patients diagnosed with temporomandibular muscle disorders, temporomandibular joint internal derangement, or temporomandibular joint inflammation based on clinical and radiological examinations.
•4) Individuals who voluntarily decide to participate in this clinical trial and provide written consent.

•1.Structural disorders of the temporomandibular joint: Ankylosis, tumors.
•2.Traumatic disorders of the temporomandibular joint: Mandibular Condylar Fracture, severe trauma to the maxillofacial region (e.g., from motor vehicle accidents, assault).
•3.Individuals with rare muscular disorders such as Myasthenia gravis, Eaton-Lambert syndrome, and Amyotrophic lateral sclerosis
•4.Individuals with severe hypertension, diabetes, or other metabolic disorders.
•5.Individuals diagnosed with neurological disorders (such as Parkinson's disease, Alzheimer's disease) or psychiatric disorders.
•6.Individuals currently taking medications for sleep disorders (e.g., benzodiazepines, neuroleptic, tricyclic antidepressants) or potentially using medications not previously agreed upon, alcohol, or narcotics.
•7.Individuals undergoing orthodontic treatment or wearing other intraoral devices (except for Occlusion stabilization splint)).
•8.Individuals who have participated in another clinical trial within the past 4 weeks prior to screening.
•9.Pregnant women or individuals planning pregnancy during the clinical trial period.
•10. Any other individuals deemed unsuitable for participation in this clinical trial by the principal investigator.

发起方

Beyondmedicine