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Comparative Analysis of the Effectiveness of the Use of Nimesulide and CBD Oil in Patients With Pain in the Preauricular Region Due to the Pain-dysfunctional Syndrome of the Temporomandibular Joint.

NCT ID: NCT04609748

Last Updated: 2021-01-29

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

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-27

Study Completion Date

2021-12-31

Brief Summary

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During the study, the effectiveness of analgesic therapy with nimmsulide and cannabidiol oil will be compared.

Two study groups will be formed. The study will be conducted on patients reporting to the Dental Prosthetics Clinic of PUM in Szczecin. Patients aged 18-65 years with pain located in the area of the temporomandibular joint and the preauricular area, resulting from a dysfunction of the temporomandibular joint, will be included in the study.

Detailed Description

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Conditions

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Temporomandibular Joint Disorders Temporomandibular Joint Dysfunction Syndrome Temporomandibular Joint Pain

Keywords

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temporomandibular joint CBD oil non steroid antyinflammatory drug nimesulide

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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The group that received nimesulide

Group Type ACTIVE_COMPARATOR

Nimesulide

Intervention Type DRUG

Nimessulid will be given twice a day - 2x100mg, applied orally. The therapy will last 15 days.

The group that received CBD Oil

Group Type EXPERIMENTAL

Cannabidiol Oil

Intervention Type DRUG

Cannabidiol oil will be given twice a day, in a dose of 33,6mg, applied orally. The therapy will last 15 days.

Interventions

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Cannabidiol Oil

Cannabidiol oil will be given twice a day, in a dose of 33,6mg, applied orally. The therapy will last 15 days.

Intervention Type DRUG

Nimesulide

Nimessulid will be given twice a day - 2x100mg, applied orally. The therapy will last 15 days.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Patients (female and male) aged 18-65 years, able to swallow tablets
2. Patients with pain located in the temporomandibular and preauricular regions resulting from temporomandibular joint dysfunction
3. Patients with clinical diagnosis of Temporomandibular Joint Dysfunction

Exclusion Criteria

1. patients with clinically diagnosed acute inflammation of the outer ear, middle ear, sinuses of the nose
2. patients allergic to nimesulide or cannabidiol oil
3. patients with contraindications to include therapy with nimesulide or cannabidiol oil such as:

* gastric or duodenal ulcer disease,
* severe blood clotting disorders,
* severe liver dysfunction,
* severe renal impairment,
* severe heart failure, pregnancy,
* breastfeeding,
* concomitant intake of citrochrome blockers CYP3A4 or CYPP2D6 (warfarin, macrolides, calcium channel blockers, benzodiazepines, cyclosporine, sildenafil, SSRI, tricyclic antidepressants, opioids)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pomeranian Medical University Szczecin

OTHER

Sponsor Role lead

Responsible Party

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Dalewski Bartosz

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Chair and Depratment of Dental Prosthetics

Szczecin, , Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Bartosz Dalewski, DMD, PhD

Role: CONTACT

Phone: 914661717

Email: [email protected]

Kamila Szczuchniak, DMD

Role: CONTACT

Facility Contacts

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Bartosz Dalewski, DMD, PhD

Role: primary

Other Identifiers

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KB-0012/149/2020

Identifier Type: -

Identifier Source: org_study_id