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.

Temporomandibular Joint Disorders Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04609748
• Other study ID #: KB-0012/149/2020
• Status: Recruiting
• Phase: Phase 2
• Start date: January 27, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: January 2021
• Source: Pomeranian Medical University Szczecin
• Contact: Bartosz Dalewski, DMD, PhD
• Phone: 914661717
• Email: bartosz.dalewski[@]pum.edu.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Arthralgia
• Joint Diseases
• Syndrome
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome
• Temporomandibular Joint Pain

Intervention

Drug:
• Cannabidiol Oil
Cannabidiol oil will be given twice a day, in a dose of 33,6mg, applied orally. The therapy will last 15 days.
• Nimesulide
Nimessulid will be given twice a day - 2x100mg, applied orally. The therapy will last 15 days.

Locations

Country	Name	City	State
Poland	Chair and Depratment of Dental Prosthetics	Szczecin

Sponsors (1)

Lead Sponsor	Collaborator
Pomeranian Medical University Szczecin

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Psychological conditions	Measured on The General Health Questionnaire-28 (GHQ-28)	15 days