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

Primary Purpose

Temporomandibular Disorder, Myofascial Pain, Cannabis

Status
Unknown status
Phase
Phase 2
Locations
Poland
Study Type
Interventional
Intervention
CBD occlusal appliance
Acrylic resin occlusal appliance
Sponsored by
Medical University of Silesia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Temporomandibular Disorder focused on measuring Temporomandibular Disorder, Myofascial Pain, Cannabis, Electromyography, Occlusal appliance, CBD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Department of TMD Silesian Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

CBD occlusal appliance

occlusal appliance

Arm Description

CBD occlusal appliance

Traditional material occlusal appliance

Outcomes

Primary Outcome Measures

Reduction of sEMG activity of masseter muscle
Reduction of sEMG activity of masseter muscle

Secondary Outcome Measures

Reduction of pain intensity in VAS
Reduction of pain intensity in VAS

Full Information

First Posted
February 25, 2021
Last Updated
February 25, 2021
Sponsor
Medical University of Silesia
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1. Study Identification

Unique Protocol Identification Number
NCT04775030
Brief Title
Methodology for Developing an Occlusal Appliance With CBD Active Carrier
Acronym
CBD-OCC-APP
Official Title
Methodology for Developing an Occlusal Appliance With CBD Active Carrier
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
January 1, 2022 (Anticipated)
Study Completion Date
January 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Silesia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Disorder, Myofascial Pain, Cannabis, Electromyography, Occlusal Appliance, CBD
Keywords
Temporomandibular Disorder, Myofascial Pain, Cannabis, Electromyography, Occlusal appliance, CBD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
experimental and control group
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CBD occlusal appliance
Arm Type
Experimental
Arm Description
CBD occlusal appliance
Arm Title
occlusal appliance
Arm Type
Placebo Comparator
Arm Description
Traditional material occlusal appliance
Intervention Type
Drug
Intervention Name(s)
CBD occlusal appliance
Other Intervention Name(s)
CBD OCC APP
Intervention Description
Occlusal appliance manufactured with CBD molecules released from material to patients oral cavity during sleep time
Intervention Type
Device
Intervention Name(s)
Acrylic resin occlusal appliance
Other Intervention Name(s)
ACRYLIC OCC APP
Intervention Description
Acrylic resin occlusal appliance during sleep time
Primary Outcome Measure Information:
Title
Reduction of sEMG activity of masseter muscle
Description
Reduction of sEMG activity of masseter muscle
Time Frame
40 days
Secondary Outcome Measure Information:
Title
Reduction of pain intensity in VAS
Description
Reduction of pain intensity in VAS
Time Frame
40 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aleksandra Nitecka-Buchta, Adiunct
Phone
601899069
Email
aleksandranitecka@poczta.onet.pl
First Name & Middle Initial & Last Name or Official Title & Degree
Stefan Baron, Prof
Phone
0048322717217
Email
sbaron@sum.edu.pl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Magdalena Antonowicz, Adiunct
Organizational Affiliation
Technical University of Silesia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of TMD Silesian Medical University
City
Zabrze
ZIP/Postal Code
41-800
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefan Baron, Prof
Phone
0048322717217
Email
s.baron@sum.edu.pl
First Name & Middle Initial & Last Name & Degree
Aleksandra Nitecka-Buchta, D.M.D.

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
15327040
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.
Results Reference
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PubMed Identifier
24778283
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: 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.
Results Reference
background
PubMed Identifier
24482784
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.
Results Reference
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PubMed Identifier
29926505
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.
Results Reference
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PubMed Identifier
31698733
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.
Results Reference
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Methodology for Developing an Occlusal Appliance With CBD Active Carrier

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