Assesment of ODF ( Oral Dissolvable Film) With Long-term CBD Release in the Treatment of Temporomandibular Disorders
Status: Unknown
Location: See location...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: t
View:
• 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)
Locations
Other Locations
Poland
Department of TMD
RECRUITING
Zabrze
Time Frame
Start Date: 2023-07-18
Completion Date: 2023-08-30
Participants
Target number of participants: 30
Treatments
Experimental: 5 % polymers with CBD application
Bilateral application of 5% polymer gel with CBD intraorally, on the masseter muscle
Experimental: 10 % polymers with CBD application
Bilateral application of 10% polymer gel with CBD intraorally, on the masseter muscle
Placebo_comparator: Placebo group
Application of polymers without CBD on the masseter muscles, bilaterally
Sponsors
Leads: Medical University of Silesia