CBD-OCC-APP: Methodology for Developing an Occlusal Appliance With CBD Active Carrier
Study Details
Study Description
Brief Summary
Evaluation of the efficacy of the occlusal appliance with active cannabidiol (CBD) molecules in TMD patients
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2/Phase 3 |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: CBD occlusal appliance CBD occlusal appliance |
Drug: CBD occlusal appliance
Occlusal appliance manufactured with CBD molecules released from material to patients oral cavity during sleep time
Other Names:
|
| Placebo Comparator: occlusal appliance Traditional material occlusal appliance |
Device: Acrylic resin occlusal appliance
Acrylic resin occlusal appliance during sleep time
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Reduction of sEMG activity of masseter muscle [40 days]
Reduction of sEMG activity of masseter muscle
Secondary Outcome Measures
- Reduction of pain intensity in VAS [40 days]
Reduction of pain intensity in VAS
Eligibility Criteria
Criteria
Inclusion Criteria:
-
patient agreement to take part in the study
-
RDC/TMD group Ia and Ib
-
Bruxism Index> 3 ( Brux-off polysomnography)
Exclusion Criteria:
-
CBD allergy/hypersensitivity/ addiction
-
Therapy with analgesic drugs
-
Therapy with drugs affecting muscle function
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Fixed or removable dental prosthesis
-
Ongoing orthodontic treatment
-
Other general disorders affecting muscle tension
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of TMD Silesian Medical University | Zabrze | Poland | 41-800 |
Sponsors and Collaborators
- Medical University of Silesia
Investigators
- Principal Investigator: Magdalena Antonowicz, Adiunct, Technical University of Silesia
Study Documents (Full-Text)
None provided.More Information
Publications
- Koppel 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: 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. Review.
- Lobbezoo 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.
- Nitecka-Buchta A, Nowak-Wachol A, Wachol K, Walczyńska-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). pii: E1886. doi: 10.3390/jcm8111886.
- Schiffman 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 Group†. J Oral Facial Pain Headache. 2014 Winter;28(1):6-27. doi: 10.11607/jop.1151.
- 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.
- CBD-OCC-APP