Temporomandibular DisorderPhase 2/3NCT05562635
CBD (Cannabidiol) Intraoral Application and TMD (Temporomandibular Disorders)
A Phase 2/3 study testing 5% polymer gel with CBD application and 10% polymer gel with CBD application in people with Temporomandibular Disorder and Myofascial Pain, run by Medical University of Silesia at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Temporomandibular Disorder, Myofascial Pain, Orofacial Pain
- What is being tested?
- 5% polymer gel with CBD application and 10% polymer gel with CBD application
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 sitePoland
- Study dates
- 18 Jul 2023to 30 Aug 2023
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Department of TMD
Zabrze, 41-800
Karolina Walczyńska-Dragon, PhD, 0048609289137, karolina.dragon@sum.edu.pl
Aleksandra Nitecka-Buchta, dr hab. n. med.
About this study
Official title: 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.
Read the 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.
- Conditions
- Temporomandibular Disorder, Myofascial Pain, Orofacial Pain, CBD, Bruxism
- Being tested
- 5% polymer gel with CBD application, 10% polymer gel with CBD application, Placebo intervention
- Keywords
- temporomandibular disorder, orofacial pain, CBD, bruxism, masticatory muscles
- Medical subject headings
- Temporomandibular Joint Disorders, Facial Pain, Bruxism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5% polymer gel with CBD applicationCombination product
Bilateral application of 5% polymer gel with CBD intraorally, on the masseter muscle
10% polymer gel with CBD applicationCombination product
Bilateral application of 10% polymer gel with CBD intraorally, on the masseter muscle
Placebo interventionCombination product
Application of placebo without CBD
| Study group | Role | What they receive |
|---|---|---|
| 5 % polymers with CBD application | Experimental | Bilateral application of 5% polymer gel with CBD intraorally, on the masseter muscle Receives: Combination Product: 5% polymer gel with CBD application |
| 10 % polymers with CBD application | Experimental | Bilateral application of 10% polymer gel with CBD intraorally, on the masseter muscle Receives: Combination Product: 10% polymer gel with CBD application |
| Placebo group | Placebo comparator | Application of polymers without CBD on the masseter muscles, bilaterally Receives: Combination Product: Placebo intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in masseter muscle electromyographic activity- sEMG examination
Change in masseter muscle electromyographic activity-sEMG examination
Measured: 30 days
Orofacial pain changes
Changes of felt pain recorded by means of VAS scale
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2022
- Study start18 Jul 2023 (estimated)
- Primary completion30 Jul 2023 (estimated)
- Study completion30 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Temporomandibular DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- two groups parallel study: experimental and control group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Silesia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05562635
- Sponsor's protocol ID
- CBD (Cannabidiol)
- Status last verified
- Jan 2023
- First submitted
- 31 Aug 2022
- Last updated
- 21 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41517391
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assesment of ODF ( Oral Dissolvable Film) With Long-term CBD Release in the Treatment of Temporomandibular Disorders
- ClinicalTrials.gov ID
- NCT05562635
- Acronym / sponsor ID
- CBD (Cannabidiol)
- Conditions
- Temporomandibular Disorder, Myofascial Pain, Orofacial Pain, CBD, Bruxism
- Keywords
- temporomandibular disorder, orofacial pain, CBD, bruxism, masticatory muscles
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Medical University of SilesiaUniversity, hospital or other
- Study start
- 18 Jul 2023 (estimated)
- Primary completion
- 30 Jul 2023 (estimated)
- Study completion
- 30 Aug 2023 (estimated)
- First posted
- 3 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- two groups parallel study: experimental and control group
| Arm | Type | Receives |
|---|---|---|
| 5 % polymers with CBD application | Experimental | Combination Product: 5% polymer gel with CBD applicationBilateral application of 5% polymer gel with CBD intraorally, on the masseter muscle |
| 10 % polymers with CBD application | Experimental | Combination Product: 10% polymer gel with CBD applicationBilateral application of 10% polymer gel with CBD intraorally, on the masseter muscle |
| Placebo group | Placebo comparator | Combination Product: Placebo interventionApplication of polymers without CBD on the masseter muscles, bilaterally |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5% polymer gel with CBD applicationBilateral application of 5% polymer gel with CBD intraorally, on the masseter muscle | Combination product | 5 % polymers with CBD application |
| 10% polymer gel with CBD applicationBilateral application of 10% polymer gel with CBD intraorally, on the masseter muscle | Combination product | 10 % polymers with CBD application |
| Placebo interventionApplication of placebo without CBD | Combination product | Placebo group |
Primary outcome
Change in masseter muscle electromyographic activity- sEMG examination
Time frame: 30 days
Change in masseter muscle electromyographic activity-sEMG examination
Orofacial pain changes
Time frame: 30 days
Changes of felt pain recorded by means of VAS scale
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2023.
- Derived from this study: PubMed 41517391Walczynska-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing 5% polymer gel with CBD application and 10% polymer gel with CBD application in people with Temporomandibular Disorder and Myofascial Pain, run by Medical University of Silesia at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in masseter muscle electromyographic activity- sEMG examination (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05562635, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2023.