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

Medical University of Silesia

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Bruxism; Orofacial Pain; Temporomandibular Disorder; CBD; Myofascial Pain

Treatments: Combination Product: Placebo intervention; Combination Product: 10% polymer gel with CBD application; Combination Product: 5% polymer gel with CBD application

Study type: Interventional

Funder types: Other

Identifiers

NCT05562635

CBD (Cannabidiol)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 3 patient groups, including a placebo group

5 % polymers with CBD application

Experimental group

Description:

Bilateral application of 5% polymer gel with CBD intraorally, on the masseter muscle

Treatment:

Combination Product: 5% polymer gel with CBD application

10 % polymers with CBD application

Experimental group

Description:

Bilateral application of 10% polymer gel with CBD intraorally, on the masseter muscle

Treatment:

Combination Product: 10% polymer gel with CBD application

Placebo group

Placebo Comparator group

Description:

Application of polymers without CBD on the masseter muscles, bilaterally

Treatment:

Combination Product: Placebo intervention