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.

Study Overview
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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.

Official Title
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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.

Conditions
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Temporomandibular Joint Disorders, Temporomandibular Joint Dysfunction Syndrome, Temporomandibular Joint Pain

Intervention / Treatment
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* Drug: Cannabidiol Oil
* Drug: Nimesulide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients (female and male) aged 18-65 years, able to swallow tablets Patients with pain located in the temporomandibular and preauricular regions resulting from temporomandibular joint dysfunction Patients with clinical diagnosis of Temporomandibular Joint Dysfunction Exclusion Criteria: patients with clinically diagnosed acute inflammation of the outer ear, middle ear, sinuses of the nose patients allergic to nimesulide or cannabidiol oil 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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: The group that received nimesulide<br> | Drug: Nimesulide<br>* Nimessulid will be given twice a day - 2x100mg, applied orally. The therapy will last 15 days.<br>|
| Experimental: The group that received CBD Oil<br> | Drug: Cannabidiol Oil<br>* Cannabidiol oil will be given twice a day, in a dose of 33,6mg, applied orally. The therapy will last 15 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain relief | Measured on Visual Analogue Scale (VAS) scale. It consists of a line, approximately 100mm in length, at the left end of the scale Score 0 which means no pain, at the right end of the scale Score 100mm which means worst imaginable pain | 15 days | 
| Psychological conditions | Measured on The General Health Questionnaire-28 (GHQ-28) | 15 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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temporomandibular joint, CBD oil, non steroid antyinflammatory drug, nimesulide