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NCT05562635 Clinical Trial

CBD (Cannabidiol) Intraoral Application and TMD (Temporomandibular Disorders)

Temporomandibular Disorder Clinical Trial

Official title:
Assesment of ODF ( Oral Dissolvable Film) With Long-term CBD Release in the Treatment of Temporomandibular Disorders

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05562635
Other study ID # CBD (Cannabidiol)
Secondary ID
Status Recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date July 18, 2023
Est. completion date August 30, 2023

Study information
Verified date January 2023
Source Medical University of Silesia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 30
Est. completion date August 30, 2023
Est. primary completion date July 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Combination Product:
• 5% polymer gel with CBD application
Bilateral application of 5% polymer gel with CBD intraorally, on the masseter muscle
• 10% polymer gel with CBD application
Bilateral application of 10% polymer gel with CBD intraorally, on the masseter muscle
• Placebo intervention
Application of placebo without CBD

Locations
Country Name City State
Poland Department of TMD Zabrze

Sponsors (1)
Lead Sponsor Collaborator
Medical University of Silesia

Country where clinical trial is conducted

Poland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in masseter muscle electromyographic activity- sEMG examination Change in masseter muscle electromyographic activity-sEMG examination 30 days
Primary Orofacial pain changes Changes of felt pain recorded by means of VAS scale 30 days
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