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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 5 % polymers with CBD application | Experimental | Bilateral application of 5% polymer gel with CBD intraorally, on the masseter muscle |
|
| 10 % polymers with CBD application | Experimental | Bilateral application of 10% polymer gel with CBD intraorally, on the masseter muscle |
|
| Placebo group | Placebo Comparator | Application of polymers without CBD on the masseter muscles, bilaterally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5% polymer gel with CBD application | Combination Product | Bilateral application of 5% polymer gel with CBD intraorally, on the masseter muscle |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of TMD | Recruiting | Zabrze | 41-800 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41517391 | Derived | Walczynska-Dragon K, Grzyb A, Dawiec K, Pawlowska M, Fiegler-Rudol J, Hadzik P, Nitecka-Buchta A, Baron S. Halloysite-Assisted Delivery of Cannabidiol for the Management of Temporomandibular Pain: A Pilot Study. J Clin Med. 2025 Dec 24;15(1):145. doi: 10.3390/jcm15010145. |
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two groups parallel study: experimental and control group
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Double masking
| 10% polymer gel with CBD application | Combination Product | Bilateral application of 10% polymer gel with CBD intraorally, on the masseter muscle |
|
| Placebo intervention | Combination Product | Application of placebo without CBD |
|
| ID | Term |
|---|---|
| D013705 | Temporomandibular Joint Disorders |
| D005157 | Facial Pain |
| D002012 | Bruxism |
| ID | Term |
|---|---|
| D017271 | Craniomandibular Disorders |
| D008336 | Mandibular Diseases |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D007592 | Joint Diseases |
| D009135 | Muscular Diseases |
| D009057 | Stomatognathic Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014076 | Tooth Diseases |
| D006184 | Habits |
| D001519 | Behavior |
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