Temporomandibular DisorderPhase 2/3CBD-OCC-APPNCT04775030
Methodology for Developing an Occlusal Appliance With CBD Active Carrier
A Phase 2/3 study testing CBD occlusal appliance and Acrylic resin occlusal appliance in people with Temporomandibular Disorder and Myofascial Pain, run by Medical University of Silesia at 1 site in Poland.
Trial summary
Evaluation of the efficacy of the occlusal appliance with active cannabidiol (CBD) molecules in TMD patients Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Temporomandibular Disorder, Myofascial Pain, Cannabis
- What is being tested?
- CBD occlusal appliance and Acrylic resin occlusal appliance
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jan 2021to 1 Jan 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patient agreement to take part in the study
- RDC/TMD group Ia and Ib
- Bruxism Index> 3 ( Brux-off polysomnography)
Who cannot join
- CBD allergy/hypersensitivity/ addiction
- Therapy with analgesic drugs
- Therapy with drugs affecting muscle function
- Fixed or removable dental prosthesis
- Ongoing orthodontic treatment
- Other general disorders affecting muscle tension
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Department of TMD Silesian Medical University
Zabrze, 41-800
Stefan Baron, Prof, 0048322717217, s.baron@sum.edu.pl
Aleksandra Nitecka-Buchta, D.M.D.
About this study
Evaluation of the efficacy of the occlusal appliance with active cannabidiol (CBD) molecules in TMD patients
Read the detailed description
Occlusal appliance therapies are used in TMD patients. In this research the active CBD molecules will be released from the occlusal appliance during nighttime, in population of patients suffering from TMD. The effectiveness of the myorelaxation (sEMG of mastcatory muscles activity) and analgesic effect( VAS analysis) of occlusal appliance with the CBD molecules will be compared to the traditional acrylic-resin material used so far for occlusal appliance manufacture. The aim of the research is the evaluation of the innovative material effectiveness, used for the production of the occlusal appliance.
- Conditions
- Temporomandibular Disorder, Myofascial Pain, Cannabis, Electromyography, Occlusal Appliance, CBD
- Being tested
- CBD occlusal appliance, Acrylic resin occlusal appliance
- Keywords
- Temporomandibular Disorder, Myofascial Pain, Cannabis, Electromyography, Occlusal appliance, CBD
- Medical subject headings
- Temporomandibular Joint Disorders, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBD occlusal applianceDrug
Also called CBD OCC APP
Occlusal appliance manufactured with CBD molecules released from material to patients oral cavity during sleep time
Acrylic resin occlusal applianceDevice
Also called ACRYLIC OCC APP
Acrylic resin occlusal appliance during sleep time
| Study group | Role | What they receive |
|---|---|---|
| CBD occlusal appliance | Experimental | CBD occlusal appliance Receives: Drug: CBD occlusal appliance |
| occlusal appliance | Placebo comparator | Traditional material occlusal appliance Receives: Device: Acrylic resin occlusal appliance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of sEMG activity of masseter muscle
Reduction of sEMG activity of masseter muscle
Measured: 40 days
Secondary outcomes (1)
Reduction of pain intensity in VAS
Reduction of pain intensity in VAS
Measured: 40 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start1 Jan 2021
- Primary completion1 Jan 2022 (estimated)
- Study completion1 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- experimental and control group
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Silesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aleksandra Nitecka-Buchta, Medical University of Silesia
- Investigators
- Magdalena Antonowicz, Adiunct, Principal investigator, Technical University of Silesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04775030
- Sponsor's protocol ID
- CBD-OCC-APP
- Acronym
- CBD-OCC-APP
- Status last verified
- Feb 2021
- First submitted
- 25 Feb 2021
- Last updated
- 1 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vaney C, Heinzel-Gutenbrunner M, Jobin P, Tschopp F, Gattlen B, Hagen U, Schnelle M, Reif M. Efficacy, safety and tolerability of an orally administered cannabis extract in the treatment of spasticity in patients with multiple sclerosis: a randomized, double-blind, placebo-controlled, crossover study. Mult Scler. 2004 Aug;10(4):417-24. doi: 10.1191/1352458504ms1048oa.
PubMed 15327040Koppel BS, Brust JC, Fife T, Bronstein J, Youssof S, Gronseth G, Gloss D. Systematic review: efficacy and safety of medical marijuana in selected neurologic disorders [RETIRED]: report of the Guideline Development Subcommittee of the American Academy of Neurology. Neurology. 2014 Apr 29;82(17):1556-63. doi: 10.1212/WNL.0000000000000363.
PubMed 24778283Schiffman E, Ohrbach R, Truelove E, Look J, Anderson G, Goulet JP, List T, Svensson P, Gonzalez Y, Lobbezoo F, Michelotti A, Brooks SL, Ceusters W, Drangsholt M, Ettlin D, Gaul C, Goldberg LJ, Haythornthwaite JA, Hollender L, Jensen R, John MT, De Laat A, de Leeuw R, Maixner W, van der Meulen M, Murray GM, Nixdorf DR, Palla S, Petersson A, Pionchon P, Smith B, Visscher CM, Zakrzewska J, Dworkin SF; International RDC/TMD Consortium Network, International association for Dental Research; Orofacial Pain Special Interest Group, International Association for the Study of Pain. Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) for Clinical and Research Applications: recommendations of the International RDC/TMD Consortium Network* and Orofacial Pain Special Interest Groupdagger. J Oral Facial Pain Headache. 2014 Winter;28(1):6-27. doi: 10.11607/jop.1151.
PubMed 24482784Lobbezoo F, Ahlberg J, Raphael KG, Wetselaar P, Glaros AG, Kato T, Santiago V, Winocur E, De Laat A, De Leeuw R, Koyano K, Lavigne GJ, Svensson P, Manfredini D. International consensus on the assessment of bruxism: Report of a work in progress. J Oral Rehabil. 2018 Nov;45(11):837-844. doi: 10.1111/joor.12663. Epub 2018 Jun 21.
PubMed 29926505Nitecka-Buchta A, Nowak-Wachol A, Wachol K, Walczynska-Dragon K, Olczyk P, Batoryna O, Kempa W, Baron S. Myorelaxant Effect of Transdermal Cannabidiol Application in Patients with TMD: A Randomized, Double-Blind Trial. J Clin Med. 2019 Nov 6;8(11):1886. doi: 10.3390/jcm8111886.
PubMed 31698733
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methodology for Developing an Occlusal Appliance With CBD Active Carrier
- ClinicalTrials.gov ID
- NCT04775030
- Acronym / sponsor ID
- CBD-OCC-APP / CBD-OCC-APP
- Conditions
- Temporomandibular Disorder, Myofascial Pain, Cannabis, Electromyography, Occlusal Appliance, CBD
- Keywords
- Temporomandibular Disorder, Myofascial Pain, Cannabis, Electromyography, Occlusal appliance, CBD
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Medical University of SilesiaUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 1 Mar 2021 (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.
Evaluation of the efficacy of the occlusal appliance with active cannabidiol (CBD) molecules in TMD patients
Detailed description
Occlusal appliance therapies are used in TMD patients. In this research the active CBD molecules will be released from the occlusal appliance during nighttime, in population of patients suffering from TMD. The effectiveness of the myorelaxation (sEMG of mastcatory muscles activity) and analgesic effect( VAS analysis) of occlusal appliance with the CBD molecules will be compared to the traditional acrylic-resin material used so far for occlusal appliance manufacture. The aim of the research is the evaluation of the innovative material effectiveness, used for the production of the occlusal appliance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- experimental and control group
| Arm | Type | Receives |
|---|---|---|
| CBD occlusal appliance | Experimental | Drug: CBD occlusal applianceCBD occlusal appliance |
| occlusal appliance | Placebo comparator | Device: Acrylic resin occlusal applianceTraditional material occlusal appliance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patient agreement to take part in the study
- RDC/TMD group Ia and Ib
- Bruxism Index> 3 ( Brux-off polysomnography)
Key exclusion criteria (6 listed)
- CBD allergy/hypersensitivity/ addiction
- Therapy with analgesic drugs
- Therapy with drugs affecting muscle function
- Fixed or removable dental prosthesis
- Ongoing orthodontic treatment
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 |
|---|---|---|
| CBD occlusal applianceAlso: CBD OCC APPOcclusal appliance manufactured with CBD molecules released from material to patients oral cavity during sleep time | Drug | CBD occlusal appliance |
| Acrylic resin occlusal applianceAlso: ACRYLIC OCC APPAcrylic resin occlusal appliance during sleep time | Device | occlusal appliance |
Primary outcome
Reduction of sEMG activity of masseter muscle
Time frame: 40 days
Reduction of sEMG activity of masseter muscle
1 secondary outcome
Reduction of pain intensity in VAS
Time frame: 40 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2021.
- Background: PubMed 15327040Vaney C, Heinzel-Gutenbrunner M, Jobin P, Tschopp F, Gattlen B, Hagen U, Schnelle M, Reif M. Efficacy, safety and tolerability of an orally administered cannabis extract in the treatment of spasticity in patients with multiple sclerosis: a randomized, double-blind, placebo-controlled, crossover study. Mult Scler. 2004 Aug;10(4):417-24. doi: 10.1191/1352458504ms1048oa.
- Background: PubMed 24778283Koppel BS, Brust JC, Fife T, Bronstein J, Youssof S, Gronseth G, Gloss D. Systematic review: efficacy and safety of medical marijuana in selected neurologic disorders [RETIRED]: report of the Guideline Development Subcommittee of the American Academy of Neurology. Neurology. 2014 Apr 29;82(17):1556-63. doi: 10.1212/WNL.0000000000000363.
- Background: PubMed 24482784Schiffman E, Ohrbach R, Truelove E, Look J, Anderson G, Goulet JP, List T, Svensson P, Gonzalez Y, Lobbezoo F, Michelotti A, Brooks SL, Ceusters W, Drangsholt M, Ettlin D, Gaul C, Goldberg LJ, Haythornthwaite JA, Hollender L, Jensen R, John MT, De Laat A, de Leeuw R, Maixner W, van der Meulen M, Murray GM, Nixdorf DR, Palla S, Petersson A, Pionchon P, Smith B, Visscher CM, Zakrzewska J, Dworkin SF; International RDC/TMD Consortium Network, International association for Dental Research; Orofacial Pain Special Interest Group, International Association for the Study of Pain. Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) for Clinical and Research Applications: recommendations of the International RDC/TMD Consortium Network* and Orofacial Pain Special Interest Groupdagger. J Oral Facial Pain Headache. 2014 Winter;28(1):6-27. doi: 10.11607/jop.1151.
- Background: PubMed 29926505Lobbezoo F, Ahlberg J, Raphael KG, Wetselaar P, Glaros AG, Kato T, Santiago V, Winocur E, De Laat A, De Leeuw R, Koyano K, Lavigne GJ, Svensson P, Manfredini D. International consensus on the assessment of bruxism: Report of a work in progress. J Oral Rehabil. 2018 Nov;45(11):837-844. doi: 10.1111/joor.12663. Epub 2018 Jun 21.
- Background: PubMed 31698733Nitecka-Buchta A, Nowak-Wachol A, Wachol K, Walczynska-Dragon K, Olczyk P, Batoryna O, Kempa W, Baron S. Myorelaxant Effect of Transdermal Cannabidiol Application in Patients with TMD: A Randomized, Double-Blind Trial. J Clin Med. 2019 Nov 6;8(11):1886. doi: 10.3390/jcm8111886.
- 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.
Magdalena Antonowicz, Adiunct principal investigator
Technical University of Silesia
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 CBD occlusal appliance and Acrylic resin occlusal appliance 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 3 inclusion and 6 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 1 Mar 2021. 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?
Contact Aleksandra Nitecka-Buchta, Adiunct (601899069, aleksandranitecka@poczta.onet.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of sEMG activity of masseter muscle (time frame: 40 days). 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 NCT04775030, which also lists 5 linked publications.
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 1 Mar 2021.