NCT04775030

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 1, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

March 1, 2021

Status Verified

February 1, 2021

Enrollment Period

1 year

First QC Date

February 25, 2021

Last Update Submit

February 25, 2021

Conditions

Temporomandibular DisorderMyofascial PainCannabisElectromyographyOcclusal ApplianceCBD

Keywords

Temporomandibular DisorderMyofascial PainCannabisElectromyographyOcclusal applianceCBD

Outcome Measures

Primary Outcomes (1)

  • Reduction of sEMG activity of masseter muscle

    Reduction of sEMG activity of masseter muscle

    40 days

Secondary Outcomes (1)

  • Reduction of pain intensity in VAS

    40 days

Study Arms (2)

CBD occlusal appliance

EXPERIMENTAL

CBD occlusal appliance

Drug: CBD occlusal appliance

occlusal appliance

PLACEBO COMPARATOR

Traditional material occlusal appliance

Device: Acrylic resin occlusal appliance

Interventions

CBD occlusal applianceDRUG

Occlusal appliance manufactured with CBD molecules released from material to patients oral cavity during sleep time

Also known as: CBD OCC APP
CBD occlusal appliance
Acrylic resin occlusal applianceDEVICE

Acrylic resin occlusal appliance during sleep time

Also known as: ACRYLIC OCC APP
occlusal appliance

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patient agreement to take part in the study
  • RDC/TMD group Ia and Ib
  • Bruxism Index\> 3 ( Brux-off polysomnography)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of TMD Silesian Medical University

Zabrze, 41-800, Poland

RECRUITING

Related Publications (5)

  • 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.

    PMID: 15327040BACKGROUND

  • 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.

    PMID: 24778283BACKGROUND

  • 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.

    PMID: 24482784BACKGROUND

  • 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.

    PMID: 29926505BACKGROUND

  • 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.

    PMID: 31698733BACKGROUND

MeSH Terms

Conditions

Temporomandibular Joint DisordersMarijuana Abuse

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic DiseasesSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Magdalena Antonowicz, Adiunct

    Technical University of Silesia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Aleksandra Nitecka-Buchta, Adiunct

CONTACT

601899069aleksandranitecka@poczta.onet.pl

Stefan Baron, Prof

CONTACT

0048322717217sbaron@sum.edu.pl

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: experimental and control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
dr n. med.

Study Record Dates

First Submitted

February 25, 2021

First Posted

March 1, 2021

Study Start

January 1, 2021

Primary Completion

January 1, 2022

Study Completion

January 1, 2023

Last Updated

March 1, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)