Methodology for Developing an Occlusal Appliance With CBD Active Carrier

Temporomandibular Disorder Clinical Trial

— CBD-OCC-APP  

Official title:

Methodology for Developing an Occlusal Appliance With CBD Active Carrier

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04775030
• Other study ID #: CBD-OCC-APP
• Status: Recruiting
• Phase: Phase 2/Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Cannabis
• CBD
• Electromyography
• Marijuana Abuse
• Myofascial Pain
• Occlusal Appliance
• Temporomandibular Disorder
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

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