CBD (Cannabidiol) Intraoral Application and TMD (Temporomandibular Disorders)

Study Overview
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Brief Summary
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The aim of the project is to assess the effectiveness of reducing the masseter muscles tension and hyperactivity in patients with a painful form of TMD by using polymers containing CBD compared to placebo polymers.

Detailed Description
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Since the healing properties of CBD have been known for a long time, the assumption of the proposed research is to reduce the tension of the masseter muscles, reduce the bruxism index and occlusal strength, as well as reduce pain, from which patients with TMD suffer. CBD intraoral application therapy seems promising in that field. Patients attending The Department of TMD in Zabrze, Polska will be randomly divided into two groups: experimental and placebo. sEMG activity values will be compared during 14 and 30 days therapy with polymers. the efficacy of the cannabis cream used in the study. Positive results will confirm the efficacy of CBD relaxing properties used in the study, compared to placebo.

Official Title
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Assesment of ODF ( Oral Dissolvable Film) With Long-term CBD Release in the Treatment of Temporomandibular Disorders

Conditions
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Temporomandibular Disorder, Myofascial Pain, Orofacial Pain, CBD, Bruxism

Intervention / Treatment
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* Combination Product: 5% polymer gel with CBD application
* Combination Product: 10% polymer gel with CBD application
* Combination Product: Placebo intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient agreement to participate into the research study Age ≥18 and ≤ 60 Good general health, Temporomandibular disorder-positive RDC/TMD examination for group Ia and Ib Presence of all teeth (with the exception of the third molars) Exclusion Criteria: Cannabis cream/ placebo cream allergy Hypersensitivity to substances to be used in the study Wounds intra oral cavity Addiction to cannabis Patients being treated with analgesic drugs and/or drugs that affect muscle function

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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: two groups parallel study: experimental and control group
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 5 % polymers with CBD application<br>Bilateral application of 5% polymer gel with CBD intraorally, on the masseter muscle | Combination Product: 5% polymer gel with CBD application<br>* Bilateral application of 5% polymer gel with CBD intraorally, on the masseter muscle<br>|
| Experimental: 10 % polymers with CBD application<br>Bilateral application of 10% polymer gel with CBD intraorally, on the masseter muscle | Combination Product: 10% polymer gel with CBD application<br>* Bilateral application of 10% polymer gel with CBD intraorally, on the masseter muscle<br>|
| Placebo Comparator: Placebo group<br>Application of polymers without CBD on the masseter muscles, bilaterally | Combination Product: Placebo intervention<br>* Application of placebo without CBD<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in masseter muscle electromyographic activity- sEMG examination | Change in masseter muscle electromyographic activity-sEMG examination | 30 days | 
| Orofacial pain changes | Changes of felt pain recorded by means of VAS scale | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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temporomandibular disorder, orofacial pain, CBD, bruxism, masticatory muscles