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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04775030
Other study ID # CBD-OCC-APP
Secondary ID
Status Recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date January 1, 2021
Est. completion date January 1, 2023

Study information

Verified date February 2021
Source Medical University of Silesia
Contact Aleksandra Nitecka-Buchta, Adiunct
Phone 601899069
Email aleksandranitecka@poczta.onet.pl
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Evaluation of the efficacy of the occlusal appliance with active cannabidiol (CBD) molecules in TMD patients


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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
CBD occlusal appliance
Occlusal appliance manufactured with CBD molecules released from material to patients oral cavity during sleep time
Device:
Acrylic resin occlusal appliance
Acrylic resin occlusal appliance during sleep time

Locations

Country Name City State
Poland Department of TMD Silesian Medical University Zabrze

Sponsors (1)

Lead Sponsor Collaborator
Medical University of Silesia

Country where clinical trial is conducted

Poland, 

References & Publications (5)

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

Outcome

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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