Interventional Recruiting Phase 2/Phase 3
NCT05562635 on ClinicalTrials.gov
CBD (Cannabidiol) Intraoral Application and TMD (Temporomandibular Disorders)
Official title: Assesment of ODF ( Oral Dissolvable Film) With Long-term CBD Release in the Treatment of Temporomandibular Disorders
- Sponsor: Medical University of Silesia
- Enrollment: 30 (Estimated)
- Study start: 2023-07-18 (Estimated)
- Primary completion: 2023-07-30 (Estimated)
- Study completion: 2023-08-30 (Estimated)
- Allocation: Randomized
- InterventionModel: Parallel
- InterventionModelDescription: two groups parallel study: experimental and control group
- Masking: Triple (Participant, Care Provider, Investigator)
- PrimaryPurpose: Treatment
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.
Conditions
- Temporomandibular Disorder
- Myofascial Pain
- Orofacial Pain
- CBD
- Bruxism
Intervention / Treatment
- Combination Product: 5% polymer gel with CBD application
- Combination Product: 10% polymer gel with CBD application
- Combination Product: Placebo intervention
Primary Outcome Measures
-
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
Locations and Investigators
-
Department of TMD, Zabrze, Poland (Recruiting)
- Karolina Walczyńska-Dragon, PhD
- Aleksandra Nitecka-Buchta, dr hab. n. med.
- Stefan Baron, Prof