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

Phase 2

Recruiting

• Conditions: Temporomandibular Disorder; Bruxism; Myofascial Pain; CBD; Orofacial Pain
• Interventions: Combination Product: 10% polymer gel with CBD application; Combination Product: 5% polymer gel with CBD application; Combination Product: Placebo intervention

• Registration Number: NCT05562635
• Lead Sponsor: Medical University of Silesia

Brief 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.

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 Timeline

• Study First Submitted: 2022-08-31
• Study First Submitted QC: 2022-09-28
• Study First Posted: 2022-10-03
• Status Verified: 2023-01
• Study Start: 2023-07-18
• Last Update Submitted: 2023-07-20
• Last Update Posted: 2023-07-21
• Primary Completion: 2023-07-30
• Study Completion: 2023-08-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
10 % polymers with CBD application	10% polymer gel with CBD application	Bilateral application of 10% polymer gel with CBD intraorally, on the masseter muscle
5 % polymers with CBD application	5% polymer gel with CBD application	Bilateral application of 5% polymer gel with CBD intraorally, on the masseter muscle
Placebo group	Placebo intervention	Application of polymers without CBD on the masseter muscles, bilaterally

Primary Outcome Measures

Name	Time	Method
Change in masseter muscle electromyographic activity- sEMG examination	30 days	Change in masseter muscle electromyographic activity-sEMG examination
Orofacial pain changes	30 days	Changes of felt pain recorded by means of VAS scale

Trial Locations

Locations (1)

Department of TMD; 🇵🇱 Zabrze, Poland