The effectiveness of using systemic oral tablet Reparil 'Registered Trademark' vs. topical gel of Reparil 'Registered Trademark' compared to placebo in the treatment of temporomandibular joint (TMJ), masticatory muscle pain, mandibular function and Tolerability to treatment.

Hawler Medical University0 sites50 target enrollmentStarted: April 2, 2015Last updated: January 13, 2020

Conditions

Trial Snapshot

No summary available.

•Self report of facial ache or pain in the muscles of mastication, the TMJ, or the region in front of ear or inside the ear
•Positive clinical diagnosis of TMDs. The TMD diagnosis is classified using axis I of the research diagnostic criteria (RDC) for TMDs. The RDC diagnosis consists of joint pain at rest (spontaneous pain) and evoked pain (hyperalgesia) on palpation of the TMJ, TMJ reduction consists of reciprocal clicking or joint noise with mandibular movement examination.
•For joint pain complaint, subjects will be required to have a self-report of at least 1 month of daily or nearly daily pain.
•Subjects with myogenic pain will be included if they meet inclusion and exclusion criteria since patients with TMDs are known to exhibit muscle pain secondary to their joint dysfunction.

•Subjects with infectious arthritis, crystal induced arthropathies, musculoskeletal disorders, subjects with a primary diagnosis of myofascial pain based on the RDC;
•Subjects with pain attributable to confirmed migraine or head pain condition other than tension headache;
•Subjects with acute infection or other significant disease of teeth, ears, eyes, nose or throats; subjects with untreated depressive disorder or not on stable antidepressant medication for more than 6 months;
•Subjects with dental diseases that required ongoing treatment, which would confound the evaluation of orofacial pain;
•Subjects who are not competent in giving consents.
•Pregnant or lactating women
•Subjects with sensitivity to the ingredient of Reparil

Sponsor