CBD (Cannabidiol) Intraoral Application and TMD (Temporomandibular Disorders)

NCT ID: NCT05562635

Last Updated: 2023-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-18

Study Completion Date

2023-08-30

Brief Summary

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The aim of the project is to assess the effectiveness of reducing the masseter muscles tension and hyperactivity in patients with a painful form of TMD by using polymers containing CBD compared to placebo polymers.

Detailed Description

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Since the healing properties of CBD have been known for a long time, the assumption of the proposed research is to reduce the tension of the masseter muscles, reduce the bruxism index and occlusal strength, as well as reduce pain, from which patients with TMD suffer.

CBD intraoral application therapy seems promising in that field. Patients attending The Department of TMD in Zabrze, Polska will be randomly divided into two groups: experimental and placebo. sEMG activity values will be compared during 14 and 30 days therapy with polymers. the efficacy of the cannabis cream used in the study. Positive results will confirm the efficacy of CBD relaxing properties used in the study, compared to placebo.

Conditions

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Temporomandibular Disorder Myofascial Pain Orofacial Pain CBD Bruxism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

two groups parallel study: experimental and control group
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
Double masking

Study Groups

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5 % polymers with CBD application

Bilateral application of 5% polymer gel with CBD intraorally, on the masseter muscle

Group Type EXPERIMENTAL

5% polymer gel with CBD application

Intervention Type COMBINATION_PRODUCT

Bilateral application of 5% polymer gel with CBD intraorally, on the masseter muscle

10 % polymers with CBD application

Bilateral application of 10% polymer gel with CBD intraorally, on the masseter muscle

Group Type EXPERIMENTAL

10% polymer gel with CBD application

Intervention Type COMBINATION_PRODUCT

Bilateral application of 10% polymer gel with CBD intraorally, on the masseter muscle

Placebo group

Application of polymers without CBD on the masseter muscles, bilaterally

Group Type PLACEBO_COMPARATOR

Placebo intervention

Intervention Type COMBINATION_PRODUCT

Application of placebo without CBD

Interventions

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5% polymer gel with CBD application

Bilateral application of 5% polymer gel with CBD intraorally, on the masseter muscle

Intervention Type COMBINATION_PRODUCT

10% polymer gel with CBD application

Bilateral application of 10% polymer gel with CBD intraorally, on the masseter muscle

Intervention Type COMBINATION_PRODUCT

Placebo intervention

Application of placebo without CBD

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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Inclusion Criteria

* Patient agreement to participate into the research study
* Age ≥18 and ≤ 60
* Good general health,
* Temporomandibular disorder-positive RDC/TMD examination for group Ia and Ib
* Presence of all teeth (with the exception of the third molars)

Exclusion Criteria

* Cannabis cream/ placebo cream allergy
* Hypersensitivity to substances to be used in the study
* Wounds intra oral cavity
* Addiction to cannabis
* Patients being treated with analgesic drugs and/or drugs that affect muscle function
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medical University of Silesia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of TMD

Zabrze, , Poland

Site Status RECRUITING

Countries

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Poland

Facility Contacts

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Karolina Walczyńska-Dragon, PhD

Role: primary

0048609289137

Other Identifiers

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CBD (Cannabidiol)

Identifier Type: -

Identifier Source: org_study_id

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