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.

Pomeranian Medical University Szczecin

Status and phase: Unknown; Phase 2

Conditions: Temporomandibular Joint Pain; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome

Treatments: Drug: Nimesulide; Drug: Cannabidiol Oil

Study type: Interventional

Funder types: Other

Identifiers

NCT04609748

KB-0012/149/2020

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

The group that received nimesulide

Active Comparator group

Treatment:

Drug: Nimesulide

The group that received CBD Oil

Experimental group

Treatment:

Drug: Cannabidiol Oil