CBD (Cannabidiol) Intraoral Application and TMD (Temporomandibular Disorders)
Primary Purpose
Temporomandibular Disorder, Myofascial Pain, Orofacial Pain
Status
Recruiting
Phase
Phase 2
Locations
Poland
Study Type
Interventional
Intervention
5% polymer gel with CBD application
10% polymer gel with CBD application
Placebo intervention
Sponsored by
About this trial
This is an interventional treatment trial for Temporomandibular Disorder focused on measuring temporomandibular disorder, orofacial pain, CBD, bruxism, masticatory muscles
Eligibility Criteria
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
Sites / Locations
- Department of TMDRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
5 % polymers with CBD application
10 % polymers with CBD application
Placebo group
Arm Description
Bilateral application of 5% polymer gel with CBD intraorally, on the masseter muscle
Bilateral application of 10% polymer gel with CBD intraorally, on the masseter muscle
Application of polymers without CBD on the masseter muscles, bilaterally
Outcomes
Primary Outcome Measures
Change in masseter muscle electromyographic activity- sEMG examination
Change in masseter muscle electromyographic activity-sEMG examination
Orofacial pain changes
Changes of felt pain recorded by means of VAS scale
Secondary Outcome Measures
Full Information
NCT ID
NCT05562635
First Posted
August 31, 2022
Last Updated
July 20, 2023
Sponsor
Medical University of Silesia
1. Study Identification
Unique Protocol Identification Number
NCT05562635
Brief Title
CBD (Cannabidiol) Intraoral Application and TMD (Temporomandibular Disorders)
Official Title
Assesment of ODF ( Oral Dissolvable Film) With Long-term CBD Release in the Treatment of Temporomandibular Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 18, 2023 (Anticipated)
Primary Completion Date
July 30, 2023 (Anticipated)
Study Completion Date
August 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Silesia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Disorder, Myofascial Pain, Orofacial Pain, CBD, Bruxism
Keywords
temporomandibular disorder, orofacial pain, CBD, bruxism, masticatory muscles
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
two groups parallel study: experimental and control group
Masking
ParticipantCare ProviderInvestigator
Masking Description
Double masking
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
5 % polymers with CBD application
Arm Type
Experimental
Arm Description
Bilateral application of 5% polymer gel with CBD intraorally, on the masseter muscle
Arm Title
10 % polymers with CBD application
Arm Type
Experimental
Arm Description
Bilateral application of 10% polymer gel with CBD intraorally, on the masseter muscle
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Application of polymers without CBD on the masseter muscles, bilaterally
Intervention Type
Combination Product
Intervention Name(s)
5% polymer gel with CBD application
Intervention Description
Bilateral application of 5% polymer gel with CBD intraorally, on the masseter muscle
Intervention Type
Combination Product
Intervention Name(s)
10% polymer gel with CBD application
Intervention Description
Bilateral application of 10% polymer gel with CBD intraorally, on the masseter muscle
Intervention Type
Combination Product
Intervention Name(s)
Placebo intervention
Intervention Description
Application of placebo without CBD
Primary Outcome Measure Information:
Title
Change in masseter muscle electromyographic activity- sEMG examination
Description
Change in masseter muscle electromyographic activity-sEMG examination
Time Frame
30 days
Title
Orofacial pain changes
Description
Changes of felt pain recorded by means of VAS scale
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Department of TMD
City
Zabrze
ZIP/Postal Code
41-800
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karolina Walczyńska-Dragon, PhD
Phone
0048609289137
Email
karolina.dragon@sum.edu.pl
First Name & Middle Initial & Last Name & Degree
Aleksandra Nitecka-Buchta, dr hab. n. med.
First Name & Middle Initial & Last Name & Degree
Stefan Baron, Prof
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
CBD (Cannabidiol) Intraoral Application and TMD (Temporomandibular Disorders)
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