CBD (Cannabidiol) Intraoral Application and TMD (Temporomandibular Disorders)
Assesment of ODF ( Oral Dissolvable Film) With Long-term CBD Release in the Treatment of Temporomandibular Disorders
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jul 2023
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 31, 2022
CompletedFirst Posted
Study publicly available on registry
October 3, 2022
CompletedStudy Start
First participant enrolled
July 18, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2023
CompletedJuly 21, 2023
January 1, 2023
12 days
August 31, 2022
July 20, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in masseter muscle electromyographic activity- sEMG examination
Change in masseter muscle electromyographic activity-sEMG examination
30 days
Orofacial pain changes
Changes of felt pain recorded by means of VAS scale
30 days
Study Arms (3)
5 % polymers with CBD application
EXPERIMENTALBilateral application of 5% polymer gel with CBD intraorally, on the masseter muscle
10 % polymers with CBD application
EXPERIMENTALBilateral application of 10% polymer gel with CBD intraorally, on the masseter muscle
Placebo group
PLACEBO COMPARATORApplication of polymers without CBD on the masseter muscles, bilaterally
Interventions
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
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of TMD
Zabrze, 41-800, Poland
Related Publications (1)
Walczynska-Dragon K, Grzyb A, Dawiec K, Pawlowska M, Fiegler-Rudol J, Hadzik P, Nitecka-Buchta A, Baron S. Halloysite-Assisted Delivery of Cannabidiol for the Management of Temporomandibular Pain: A Pilot Study. J Clin Med. 2025 Dec 24;15(1):145. doi: 10.3390/jcm15010145.
PMID: 41517391DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Masking Details
- Double masking
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 31, 2022
First Posted
October 3, 2022
Study Start
July 18, 2023
Primary Completion
July 30, 2023
Study Completion
August 30, 2023
Last Updated
July 21, 2023
Record last verified: 2023-01
Data Sharing
- IPD Sharing
- Will not share