Temporomandibular Disorder Clinical Trial
— CBD-OCC-APPOfficial title:
Methodology for Developing an Occlusal Appliance With CBD Active Carrier
Evaluation of the efficacy of the occlusal appliance with active cannabidiol (CBD) molecules in TMD patients
Status | Recruiting |
Enrollment | 40 |
Est. completion date | January 1, 2023 |
Est. primary completion date | January 1, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 - Fixed or removable dental prosthesis - Ongoing orthodontic treatment - Other general disorders affecting muscle tension |
Country | Name | City | State |
---|---|---|---|
Poland | Department of TMD Silesian Medical University | Zabrze |
Lead Sponsor | Collaborator |
---|---|
Medical University of Silesia |
Poland,
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. — View Citation
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. — View Citation
Nitecka-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). pii: E1886. doi: 10.3390/jcm8111886. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reduction of sEMG activity of masseter muscle | Reduction of sEMG activity of masseter muscle | 40 days | |
Secondary | Reduction of pain intensity in VAS | Reduction of pain intensity in VAS | 40 days |
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