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Methodology for Developing an Occlusal Appliance With CBD Active Carrier (CBD-OCC-APP)

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ClinicalTrials.gov Identifier: NCT04775030
Recruitment Status : Recruiting
First Posted : March 1, 2021
Last Update Posted : March 1, 2021
Sponsor:
Information provided by (Responsible Party):
Aleksandra Nitecka-Buchta, Medical University of Silesia

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

Condition or disease Intervention/treatment Phase
Temporomandibular Disorder Myofascial Pain Cannabis Electromyography Occlusal Appliance CBD Drug: CBD occlusal appliance Device: Acrylic resin occlusal appliance 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: experimental and control group
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Methodology for Developing an Occlusal Appliance With CBD Active Carrier
Actual Study Start Date : January 1, 2021
Estimated Primary Completion Date : January 1, 2022
Estimated Study Completion Date : January 1, 2023

Resource links provided by the National Library of Medicine


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 Name: CBD OCC APP

Placebo Comparator: occlusal appliance
Traditional material occlusal appliance
Device: Acrylic resin occlusal appliance
Acrylic resin occlusal appliance during sleep time
Other Name: ACRYLIC OCC APP




Primary Outcome Measures :
  1. Reduction of sEMG activity of masseter muscle [ Time Frame: 40 days ]
    Reduction of sEMG activity of masseter muscle


Secondary Outcome Measures :
  1. Reduction of pain intensity in VAS [ Time Frame: 40 days ]
    Reduction of pain intensity in VAS



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04775030


Contacts
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Contact: Aleksandra Nitecka-Buchta, Adiunct 601899069 aleksandranitecka@poczta.onet.pl
Contact: Stefan Baron, Prof 0048322717217 sbaron@sum.edu.pl

Locations
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Poland
Department of TMD Silesian Medical University Recruiting
Zabrze, Poland, 41-800
Contact: Stefan Baron, Prof    0048322717217    s.baron@sum.edu.pl   
Principal Investigator: Aleksandra Nitecka-Buchta, D.M.D.         
Sponsors and Collaborators
Medical University of Silesia
Investigators
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Principal Investigator: Magdalena Antonowicz, Adiunct Technical University of Silesia
Publications:
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.

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Responsible Party: Aleksandra Nitecka-Buchta, dr n. med., Medical University of Silesia
ClinicalTrials.gov Identifier: NCT04775030    
Other Study ID Numbers: CBD-OCC-APP
First Posted: March 1, 2021    Key Record Dates
Last Update Posted: March 1, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Aleksandra Nitecka-Buchta, Medical University of Silesia:
Temporomandibular Disorder
Myofascial Pain
Cannabis
Electromyography
Occlusal appliance
CBD
Additional relevant MeSH terms:
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Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Craniomandibular Disorders
Mandibular Diseases
Jaw Diseases
Musculoskeletal Diseases
Joint Diseases
Muscular Diseases
Stomatognathic Diseases
Myofascial Pain Syndromes
Salicylic Acid
Anti-Infective Agents
Antifungal Agents
Keratolytic Agents
Dermatologic Agents