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

Sponsor

Medical University of Silesia (Other)

Overall Status

Recruiting

CT.gov ID

NCT05562635

Collaborator

(none)

Enrollment

Location

Arms

5.4

Anticipated Duration (Months)

5.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Temporomandibular Disorder Myofascial Pain Orofacial Pain CBD Bruxism	Combination Product: 5% polymer gel with CBD application Combination Product: 10% polymer gel with CBD application Combination Product: Placebo intervention	Phase 2/Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

two groups parallel study: experimental and control grouptwo groups parallel study: experimental and control group

Masking:

Triple (Participant, Care Provider, Investigator)

Masking Description:

Double masking

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Oct 17, 2022

Anticipated Primary Completion Date :

Jan 30, 2023

Anticipated Study Completion Date :

Mar 30, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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