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.

NCT04609748 | Unknown Phase 2

• 1 other identifier: KB-0012/149/2020
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome; Temporomandibular Joint Pain

Keywords

temporomandibular joint; CBD oil; non steroid antyinflammatory drug; nimesulide

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

The group that received nimesulide

ACTIVE COMPARATOR

Drug: Nimesulide

The group that received CBD Oil

EXPERIMENTAL

Drug: Cannabidiol Oil

Interventions

Cannabidiol Oil DRUG

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

The group that received CBD Oil

Nimesulide DRUG

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

The group that received nimesulide

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Pomeranian Medical University Szczecin: lead

Study Sites (1)

Chair and Depratment of Dental Prosthetics

Szczecin, Poland

RECRUITING

MeSH Terms

Conditions

Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome

Interventions

Cannabidiol; nimesulide

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases; Myofascial Pain Syndromes

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Central Study Contacts

Bartosz Dalewski, DMD, PhD

CONTACT

914661717; bartosz.dalewski@pum.edu.pl

Kamila Szczuchniak, DMD

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 26, 2020
• First Posted: October 30, 2020
• Study Start: January 27, 2021
• Primary Completion: July 31, 2021
• Study Completion: December 31, 2021
• Last Updated: January 29, 2021

Record last verified: 2021-01

Locations

PL (1)