Trials / Unknown
UnknownNCT05562635
CBD (Cannabidiol) Intraoral Application and TMD (Temporomandibular Disorders)
Assesment of ODF ( Oral Dissolvable Film) With Long-term CBD Release in the Treatment of Temporomandibular Disorders
- Status
- Unknown
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- Medical University of Silesia · Academic / Other
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| COMBINATION_PRODUCT | 5% polymer gel with CBD application | Bilateral application of 5% polymer gel with CBD intraorally, on the masseter muscle |
| COMBINATION_PRODUCT | 10% polymer gel with CBD application | Bilateral application of 10% polymer gel with CBD intraorally, on the masseter muscle |
| COMBINATION_PRODUCT | Placebo intervention | Application of placebo without CBD |
Timeline
- Start date
- 2023-07-18
- Primary completion
- 2023-07-30
- Completion
- 2023-08-30
- First posted
- 2022-10-03
- Last updated
- 2023-07-21
Locations
1 site across 1 country: Poland
Source: ClinicalTrials.gov record NCT05562635. Inclusion in this directory is not an endorsement.