Clinical trial NCT04775030: Methodology for Developing an Occlusal Appliance With CBD Active Carrier
Official title: Methodology for Developing an Occlusal Appliance With CBD Active Carrier
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Temporomandibular Disorder
Myofascial Pain
Cannabis
Electromyography
Occlusal Appliance
CBD
Keywords: Temporomandibular Disorder
Myofascial Pain
Cannabis
Electromyography
Occlusal appliance
CBD
Lead sponsor: Medical University of Silesia
Sponsor class: OTHER
First posted: 2021-03-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: experimental and control group
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility 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
* Fixed or removable dental prosthesis
* Ongoing orthodontic treatment
* Other general disorders affecting muscle tension

Primary outcomes:
measure: Reduction of sEMG activity of masseter muscle
timeFrame: 40 days
Secondary outcomes:
measure: Reduction of pain intensity in VAS
timeFrame: 40 days
Other outcomes:
Locations:
city: Zabrze
country: Poland
facility: Department of TMD Silesian Medical University
Study officials:
affiliation: Technical University of Silesia
name: Magdalena Antonowicz, Adiunct
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1191/1352458504ms1048oa.
citation: 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 [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.
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 Groupdagger. J Oral Facial Pain Headache. 2014 Winter;28(1):6-27. doi: 10.11607/jop.1151.
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.
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):1886. doi: 10.3390/jcm8111886.