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

February 25, 2021 updated by: Aleksandra Nitecka-Buchta, Medical University of Silesia
Evaluation of the efficacy of the occlusal appliance with active cannabidiol (CBD) molecules in TMD patients

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Poland
      • Zabrze, Poland, 41-800
        • Recruiting
        • Department of TMD Silesian Medical University
        • Contact:
        • Principal Investigator:
          • Aleksandra Nitecka-Buchta, D.M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CBD occlusal appliance
Drug: CBD occlusal appliance
Occlusal appliance manufactured with CBD molecules released from material to patients oral cavity during sleep time
Other Names:
  • CBD OCC APP
Placebo Comparator: occlusal appliance
Traditional material occlusal appliance
Device: Acrylic resin occlusal appliance
Acrylic resin occlusal appliance during sleep time
Other Names:
  • ACRYLIC OCC APP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction of sEMG activity of masseter muscle
Time Frame: 40 days
Reduction of sEMG activity of masseter muscle
40 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction of pain intensity in VAS
Time Frame: 40 days
Reduction of pain intensity in VAS
40 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Silesia

Investigators

  • Principal Investigator: Magdalena Antonowicz, Adiunct, Technical University of Silesia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Anticipated)

January 1, 2022

Study Completion (Anticipated)

January 1, 2023

Study Registration Dates

First Submitted

February 25, 2021

First Submitted That Met QC Criteria

February 25, 2021

First Posted (Actual)

March 1, 2021

Study Record Updates

Last Update Posted (Actual)

March 1, 2021

Last Update Submitted That Met QC Criteria

February 25, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CBD-OCC-APP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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