Temporomandibular Joint Disorders, Temporomandibular Joint Dysfunction Syndrome, Temporomandibular Joint Pain
Conditions
Keywords
temporomandibular joint, CBD oil, non steroid antyinflammatory drug, nimesulide
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.
Interventions
DRUGCannabidiol Oil
Cannabidiol oil will be given twice a day, in a dose of 33,6mg, applied orally. The therapy will last 15 days.
DRUGNimesulide
Nimessulid will be given twice a day - 2x100mg, applied orally. The therapy will last 15 days.
Sponsors
Pomeranian Medical University Szczecin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Psychological conditions | 15 days | Measured on The General Health Questionnaire-28 (GHQ-28) |
Countries
Poland
Contacts
Primary ContactBartosz Dalewski, DMD, PhD
Backup ContactKamila Szczuchniak, DMD
Outcome results
None listed