None listed
Conditions
Brief summary
To compare 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.
Interventions
Reparil dragees
COMPOSITION:
Aescin 1,0 g
Diethylamine salicylate 5,0 g
Dose:2 dragees (oral administration)
Duration 3 times daily
Mode of administration: oral drag
Method of monitor adherence: follow up the patients weekly for the progress of treatment with the compliance to treatment, by telephone or messenger or visit.
Duration of treatment: 1 month
Follow up duration: 3 months
Reparil-gel N
COMPOSITION:
100 g contains
Aescin 1,0 g
Diethylamine salicylate
Reparil dragees COMPOSITION: Aescin 1,0 g Diethylamine salicylate 5,0 g Dose:2 dragees (oral administration) Duration 3 times daily Mode of administration: oral drag Method of monitor adherence: follow up the patients weekly for the progress of treatment with the compliance to treatment, by telephone or messenger or visit. Duration of treatment: 1 month Follow up duration: 3 months Reparil-gel N COMPOSITION: 100 g contains Aescin 1,0 g Diethylamine salicylate 5,0 g Dose:Spread a thin layer of the gel onto the skin of the affected area Duration 3 times daily Mode of administration:Topical Method of monitor adherence: follow up the patients weekly for the progress of treatment with the compliance to treatment, by telephone or messenger or visit. Duration of treatment: 1 month Follow up duration: 3 months
Sponsors
Hawler Medical University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
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.
Exclusion criteria
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
Outcome results
None listed