Temporomandibular Joint Dysfunction Syndrome
Conditions
Interventions
This is a randomized, double-blind, placebo-controlled clinical trial. A total of 50 people meeting the eligibility criteria will be randomized into 2 groups via the True Random Number Service. Both t
HP4.018.189.205
Sponsors
Faculdade de Odontologia do Campus de Araçatuba - Universidade Estadual Paulista Júlio de Mesquita Filho
Sociedade Brasileira de Estudo de Cannabis Sativa
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients at least 18 years old; both genders; able to understand the questions applied in the tests selected for the research; totally or partially dentate patients with a maximum absence of two (2) teeth per hemi-arch or rehabilitated by fixed prosthesis; patients with presence of Temporomandibular Muscle Dysfunction - TMD according to Axis I (CD/TMD) (Schiffman et al., 2014), whose main complaint of muscle pain is for a period longer than 3 months; patients who sign the Informed Consent Form
Exclusion criteria
Exclusion criteria: Patients with serious diseases, trigeminal neuralgia, tumors, neurological diseases, and psychological problems; patients with total prosthesis; people diagnosed with dental malocclusions and/or presenting with a difference between the central and maximum intercuspation ratio greater than 5 mm, overjet and overbite greater than 6 mm, and anterior or unilateral crossbite; people who have had previous history of Temporomandibular Joint - TMJ surgery, degenerative diseases and neuropathic pain; pregnancy; presence of primary headaches; people allergic to the formulation of the substance used in the study; patients with a history of psychiatric disorders, such as schizophrenia, or a family patients with a history of psychiatric disorders such as schizophrenia or a family history of this disorder; patients taking (or who have taken in the last 3 months before the beginning of the study) of any cannabis product (Liability Waiver present in Appendix 3); patients whose work requires toxicological tests, such as drivers and machine operators, competitive athletes in activities and members of the armed forces, since the substance can lead to labor losses by prohibition of these entities
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to find a reduction of chronic pain in patients with muscular TMD, using as method the application of questionnaires (Graded Chronic Pain Scale and McGrill Pain Questionnaire Short Version) and algometry and palpometry tests to compare the levels of pain in patients with the use of Cannabis Full Spectrum extract and the use of placebo, based on the finding of a variation of at least 5% between the groups | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected to find an improvement in electromyographic activity, using electromyographic examinations of the masticatory muscles as a method, in patients taking Cannabis Full Spectrum extract compared to the placebo group, based on the finding of a variation of at least 5% between the groups;It is expected to find an improvement in stress levels, using the Depression, Anxiety and Stress Scale questionnaire as a method, in patients taking Cannabis Full Spectrum extract compared to the placebo group, based on the finding of a variation of at least 5% between the groups.;It is expected to find an improvement in the range of mandibular movement, using as a method the application of the Mandibular Functional Limitation Scale questionnaire and measurement of mouth opening, in patients using Cannabis Full Spectrum extract compared to the placebo group, based on the finding of a variation of at least 5% between the groups;It is expected to find an improvement in quality of life, using questionnaires (Quality of Life Impact Profile and Health Status Questionnaire), in patients taking Cannabis Full Spectrum extract compared to the placebo group, based on the finding of a variation of at least 5% between the groups;It is expected to find an improvement in sleep quality, using the Pittsburg Sleep Quality Index questionnaire as a method, in patients taking the Full Spectrum Cannabis extract compared to the placebo group, based on the finding of a variation of at least 5% between the groups;It is expected to find a reduction in the frequency of intake of medications for pain control, using as a method the application of the Drug Intake Frequency Questionnaire, in patients using Cannabis Full Spectrum extract compared to the placebo group, based on the finding of a variation of at least 5% between the groups. | — |
Countries
Brazil
Contacts
Public ContactKarina de Carvalho
Universidade Estadual Paulista Julio de Mesquita Filho
Outcome results
None listed