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.

January 26, 2021 updated by: Dalewski Bartosz, Pomeranian Medical University Szczecin

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Kamila Szczuchniak, DMD

Study Contact Backup

Study Locations

  • Poland
      • Szczecin, Poland
        • Recruiting
        • Chair and Depratment of Dental Prosthetics
        • Contact:
        • Sub-Investigator:
          • Kamila Szczuchniak, DMD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: The group that received nimesulide
Drug: Nimesulide
Nimessulid will be given twice a day - 2x100mg, applied orally. The therapy will last 15 days.
EXPERIMENTAL: The group that received CBD Oil
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain relief
Time Frame: 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"
15 days
Psychological conditions
Time Frame: 15 days
Measured on The General Health Questionnaire-28 (GHQ-28)
15 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pomeranian Medical University Szczecin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 27, 2021

Primary Completion (ANTICIPATED)

July 31, 2021

Study Completion (ANTICIPATED)

December 31, 2021

Study Registration Dates

First Submitted

October 26, 2020

First Submitted That Met QC Criteria

October 26, 2020

First Posted (ACTUAL)

October 30, 2020

Study Record Updates

Last Update Posted (ACTUAL)

January 29, 2021

Last Update Submitted That Met QC Criteria

January 26, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KB-0012/149/2020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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