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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.

Primary Purpose

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

Status
Unknown status
Phase
Phase 2
Locations
Poland
Study Type
Interventional
Intervention
Cannabidiol Oil
Nimesulide
Sponsored by
Pomeranian Medical University Szczecin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Temporomandibular Joint Disorders focused on measuring temporomandibular joint, CBD oil, non steroid antyinflammatory drug, nimesulide

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Chair and Depratment of Dental ProstheticsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

The group that received nimesulide

The group that received CBD Oil

Arm Description

Outcomes

Primary Outcome Measures

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"
Psychological conditions
Measured on The General Health Questionnaire-28 (GHQ-28)

Secondary Outcome Measures

Full Information

First Posted
October 26, 2020
Last Updated
January 26, 2021
Sponsor
Pomeranian Medical University Szczecin
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1. Study Identification

Unique Protocol Identification Number
NCT04609748
Brief 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.
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.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 27, 2021 (Actual)
Primary Completion Date
July 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pomeranian Medical University Szczecin

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Joint Disorders, Temporomandibular Joint Dysfunction Syndrome, Temporomandibular Joint Pain
Keywords
temporomandibular joint, CBD oil, non steroid antyinflammatory drug, nimesulide

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
The group that received nimesulide
Arm Type
Active Comparator
Arm Title
The group that received CBD Oil
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Cannabidiol Oil
Intervention Description
Cannabidiol oil will be given twice a day, in a dose of 33,6mg, applied orally. The therapy will last 15 days.
Intervention Type
Drug
Intervention Name(s)
Nimesulide
Intervention Description
Nimessulid will be given twice a day - 2x100mg, applied orally. The therapy will last 15 days.
Primary Outcome Measure Information:
Title
Pain relief
Description
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"
Time Frame
15 days
Title
Psychological conditions
Description
Measured on The General Health Questionnaire-28 (GHQ-28)
Time Frame
15 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bartosz Dalewski, DMD, PhD
Phone
914661717
Email
bartosz.dalewski@pum.edu.pl
First Name & Middle Initial & Last Name or Official Title & Degree
Kamila Szczuchniak, DMD
Facility Information:
Facility Name
Chair and Depratment of Dental Prosthetics
City
Szczecin
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bartosz Dalewski, DMD, PhD
Email
bartosz.dalewski@pum.edu.pl
First Name & Middle Initial & Last Name & Degree
Kamila Szczuchniak, DMD

12. IPD Sharing Statement

Learn more about this trial

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.

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