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.

Phase 2

• Conditions: Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome; Temporomandibular Joint Pain
• Interventions: Drug: Cannabidiol Oil; Drug: Nimesulide

• Registration Number: NCT04609748
• Lead Sponsor: Pomeranian Medical University Szczecin

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2020-10-26
• Study First Submitted QC: 2020-10-26
• Study First Posted: 2020-10-30
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-26
• Study Start: 2021-01-27
• Last Update Posted: 2021-01-29
• Primary Completion: 2021-07-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The group that received CBD Oil	Cannabidiol Oil	-
The group that received nimesulide	Nimesulide	-

Primary Outcome Measures

Name	Time	Method
Psychological conditions	15 days	Measured on The General Health Questionnaire-28 (GHQ-28)
Pain relief	15 days	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"

Trial Locations

Locations (1)

Chair and Depratment of Dental Prosthetics; 🇵🇱 Szczecin, Poland