Methodology for Developing an Occlusal Appliance With CBD Active Carrier

Status

UNKNOWN

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04775030

Acronym

CBD-OCC-APP

Enrollment

Registered

2021-03-01

Start date

2021-01-01

Completion date

2023-01-01

Last updated

2021-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cannabis, CBD, Electromyography, Myofascial Pain, Occlusal Appliance, Temporomandibular Disorder

Keywords

Temporomandibular Disorder, Myofascial Pain, Cannabis, Electromyography, Occlusal appliance, CBD

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.

Interventions

DRUGCBD occlusal appliance

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

DEVICEAcrylic resin occlusal appliance

Acrylic resin occlusal appliance during sleep time

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Intervention model description

experimental and control group

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Reduction of sEMG activity of masseter muscle	40 days	Reduction of sEMG activity of masseter muscle

Secondary

Measure	Time frame	Description
Reduction of pain intensity in VAS	40 days	Reduction of pain intensity in VAS

Countries

Poland

Contacts

Primary ContactAleksandra Nitecka-Buchta, Adiunct

aleksandranitecka@poczta.onet.pl601899069

Backup ContactStefan Baron, Prof

sbaron@sum.edu.pl0048322717217

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026