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

July 20, 2023 updated by: Medical University of Silesia

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Zabrze, Poland, 41-800
        • Recruiting
        • Department of TMD
        • Contact:
        • Sub-Investigator:
          • Aleksandra Nitecka-Buchta, dr hab. n. med.
        • Sub-Investigator:
          • Stefan Baron, Prof

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 56 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 5 % polymers with CBD application
Bilateral application of 5% polymer gel with CBD intraorally, on the masseter muscle
Combination product: 5% polymer gel 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
Combination product: 10% polymer gel 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
Combination product: Placebo intervention
Application of placebo without CBD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in masseter muscle electromyographic activity- sEMG examination
Time Frame: 30 days
Change in masseter muscle electromyographic activity-sEMG examination
30 days
Orofacial pain changes
Time Frame: 30 days
Changes of felt pain recorded by means of VAS scale
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Silesia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 18, 2023

Primary Completion (Estimated)

July 30, 2023

Study Completion (Estimated)

August 30, 2023

Study Registration Dates

First Submitted

August 31, 2022

First Submitted That Met QC Criteria

September 28, 2022

First Posted (Actual)

October 3, 2022

Study Record Updates

Last Update Posted (Actual)

July 21, 2023

Last Update Submitted That Met QC Criteria

July 20, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CBD (Cannabidiol)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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