Methodology for Developing an Occlusal Appliance With CBD Active Carrier (CBD-OCC-APP)

Medical University of Silesia

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Occlusal Appliance; Cannabis; Temporomandibular Disorder; CBD; Myofascial Pain; Electromyography

Treatments: Device: Acrylic resin occlusal appliance; Drug: CBD occlusal appliance

Study type: Interventional

Funder types: Other

Identifiers

NCT04775030

CBD-OCC-APP

Details and patient eligibility

About

Evaluation of the efficacy of the occlusal appliance with active cannabidiol (CBD) molecules in TMD patients

Full description

Occlusal appliance therapies are used in TMD patients. In this research the active CBD molecules will be released from the occlusal appliance during nighttime, in population of patients suffering from TMD. The effectiveness of the myorelaxation (sEMG of mastcatory muscles activity) and analgesic effect( VAS analysis) of occlusal appliance with the CBD molecules will be compared to the traditional acrylic-resin material used so far for occlusal appliance manufacture. The aim of the research is the evaluation of the innovative material effectiveness, used for the production of the occlusal appliance.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• patient agreement to take part in the study
• RDC/TMD group Ia and Ib
• Bruxism Index> 3 ( Brux-off polysomnography)

Exclusion criteria

• CBD allergy/hypersensitivity/ addiction
• Therapy with analgesic drugs
• Therapy with drugs affecting muscle function
• Fixed or removable dental prosthesis
• Ongoing orthodontic treatment
• Other general disorders affecting muscle tension

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

CBD occlusal appliance

Experimental group

Description:

CBD occlusal appliance

Treatment:

Drug: CBD occlusal appliance

occlusal appliance

Placebo Comparator group

Description:

Traditional material occlusal appliance

Treatment:

Device: Acrylic resin occlusal appliance