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

  • STATUS
    Recruiting
  • day left to enroll
    1
  • participants needed
    30
  • sponsor
    Medical University of Silesia
Updated on 24 October 2022
Accepts healthy volunteers

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.

Details
Condition Temporomandibular Disorder, Myofascial Pain, Orofacial Pain, CBD, Bruxism
Treatment placebo intervention, 5% polymer gel with CBD application, 10% polymer gel with CBD application
Clinical Study IdentifierNCT05562635
SponsorMedical University of Silesia
Last Modified on24 October 2022

Eligibility

Yes No Not Sure

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
Clear my responses

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