Bruxism, CBD, Myofascial Pain, Orofacial Pain, Temporomandibular Disorder
Conditions
Keywords
temporomandibular disorder, orofacial pain, CBD, bruxism, masticatory muscles
Brief summary
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
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.
Interventions
COMBINATION_PRODUCT5% polymer gel with CBD application
Bilateral application of 5% polymer gel with CBD intraorally, on the masseter muscle
COMBINATION_PRODUCT10% polymer gel with CBD application
Bilateral application of 10% polymer gel with CBD intraorally, on the masseter muscle
COMBINATION_PRODUCTPlacebo intervention
Application of placebo without CBD
Sponsors
Medical University of Silesia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Double masking
Intervention model description
two groups parallel study: experimental and control group
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in masseter muscle electromyographic activity- sEMG examination | 30 days | Change in masseter muscle electromyographic activity-sEMG examination |
| Orofacial pain changes | 30 days | Changes of felt pain recorded by means of VAS scale |
Countries
Poland
Outcome results
None listed