Methodology for Developing an Occlusal Appliance With CBD Active Carrier

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

Detailed Description
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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.

Official Title
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Methodology for Developing an Occlusal Appliance With CBD Active Carrier

Conditions
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CBD, Temporomandibular Disorder, Myofascial Pain, Cannabis, Electromyography, Occlusal Appliance

Intervention / Treatment
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* Drug: CBD occlusal appliance
* Device: Acrylic resin occlusal appliance


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: experimental and control group
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBD occlusal appliance<br>CBD occlusal appliance | Drug: CBD occlusal appliance<br>* Occlusal appliance manufactured with CBD molecules released from material to patients oral cavity during sleep time<br>* Other names: CBD OCC APP;|
| Placebo Comparator: occlusal appliance<br>Traditional material occlusal appliance | Device: Acrylic resin occlusal appliance<br>* Acrylic resin occlusal appliance during sleep time<br>* Other names: ACRYLIC OCC APP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of sEMG activity of masseter muscle | Reduction of sEMG activity of masseter muscle | 40 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of pain intensity in VAS | Reduction of pain intensity in VAS | 40 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Temporomandibular Disorder, Myofascial Pain, Cannabis, Electromyography, Occlusal appliance, CBD