The efficacy and safety of Cannabis Extract in muscle pain control

Phase 2

• Conditions: Temporomandibular Joint Dysfunction Syndrome; C05.500

• Registration Number: RBR-5996nhj
• Lead Sponsor: Faculdade de Odontologia do Campus de Araçatuba - Universidade Estadual Paulista Júlio de Mesquita Filho

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-07-25
• Last Update Posted: 22 August 2023
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Not specified
• Target Recruitment: Not specified

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

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

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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